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ViperXTR CTQx CLSI 8081408(201012)

1. 14 For testing with the BD ProbeTec CT GC Q Amplified DNA Assays on the BD Viper System in Extracted Mode be sure to obtain aliquots of specimens collected in BD SurePath Preservative Fluid or PreservCyt Solution prior to processing for either the BD SurePath or ThinPrep Pap test Failure to do so may result in erroneous results 15 The BD ProbeTec CT GC Q Amplified DNA Assays may not be used with BD SurePath or PreservCyt residual specimens 16 Do not run PreservCyt specimens that have been treated with glacial acetic acid on the BD Viper System in Extracted Mode Extraction Control failures or False Negative results may occur 17 Use only polypropylene aerosol resistant pipette tips to transfer specimens to the LBC Specimen Dilution Tubes 18 Liquid based cytology specimens must be tested before the expiration date of the LBC Specimen Dilution Tube Assay Reagent 19 This reagent pack is for testing endocervical and patient collected vaginal swabs in a clinical setting male urethral swabs and male and female urine specimens with the BD Viper System in Extracted Mode 20 The Q UPT contains NAP Guard approximately 742 5 mM K EDTA WARNING H315 Causes skin irritation H319 Causes serious eye irritation H355 May cause respiratory irritation P280 Wear protective gloves protective clothing eye protection face protection P264 Wash thoroughly after handling P305 P351 P338 IF IN EYES Rinse cautiously with water for several minutes Rem
2. C Instructions Tiei Within 180 days within 7 days Within 30 Within 180 Aes ain to Within 30 days after transfer to Q UPT after transfer to of allech hours of days of g Q UPT collection collection Instructions LBC SPECIMEN COLLECTION STORAGE AND TRANSPORT BD SurePath or PreservCyt specimens must be collected using either an endocervical broom or a brush spatula combination as described in the BD SurePath or PreservCyt product insert Once collected BD SurePath or PreservCyt specimens can be stored and transported in their original vials for up to 30 days at 2 30 C prior to transfer to LBC Specimen Dilution Tubes Specimen Transfer to LBC Specimen Dilution Tubes A 0 5 mL aliquot of either the BD SurePath or PreservCyt specimen must be transferred from the original vial to the LBC Specimen Dilution Tube prior to processing for either the BD SurePath or ThinPrep Pap test Wear gloves when handling the LBC Specimen Dilution Tube and the BD SurePath or PreservCyt specimen vial If gloves come in contact with the specimen immediately change them to prevent contamination of other specimens BD SurePath Specimen Transfer NOTE Refer to the BD PrepStain Slide Processor Product Insert for instructions on removing an aliquot from the BD SurePath specimen vial prior to performing the BD SurePath liquid based Pap test 1 Label an LBC Specimen Dilution Tube with patient identification information 2 Remove t
3. For use with Package Insert BD ProbeTec Chlamydia trachomatis CT Q Amplified DNA Assay 8081408 05 2015 08 When used with the BD Viper System or the BD Viper LT System the BD ProbeTec CT Q Amplified DNA Assay involves automated ferric oxide based extraction of DNA from clinical specimens using BD FOX Extraction technology after the chemical lysis of cells followed by binding of DNA to para magnetic particles washing of the bound nucleic acid and elution in an amplification compatible buffer When present C trachomatis DNA is then detected by real time Strand Displacement Amplification SDA of a specific target sequence in the presence of a fluorescently labeled detector probe BD VIPER SYSTEM IN EXTRACTED MODE BD VIPER SYSTEM PRINCIPLES OF THE PROCEDURE The BD ProbeTec CT Q Amplified DNA Assay is designed for use with the BD ProbeTec Chlamydia trachomatis Neisseria gonorrhoeae CT GC Q specimen collection and transport devices applicable reagents the BD Viper System and BD FOX Extraction Specimens are collected and transported in their respective transport devices which preserve the integrity of C trachomatis DNA over the specified ranges of temperature and time Urine and swab specimens undergo a pre warm step in the BD Viper Lysing Heater to dissolve mucus and homogenize the specimen After cooling the specimens are loaded onto the BD Viper System which then performs all the steps involved in extraction and amplific
4. guidance and CLIA regulations for appropriate Quality Control practices The Control Set for the BD ProbeTec CT GC Q Amplified DNA Assays is provided separately One Positive and one Negative Control must be included in each assay run and for each new reagent kit lot number Controls must be positioned according to the BD Viper LT System User s Manual The CT GC Q Positive Control will monitor for substantial reagent failure only The CT GC Q Negative Control monitors for reagent and or environmental contamination Additional controls may be tested according to guidelines or requirements of local state and or federal regulations or accrediting organizations Refer to CLSI C24 A3 for additional guidance on appropriate internal quality control testing practices The Positive Control contains approximately 2400 copies per mL of pCTB4 and pGCint3 linearized plasmids The Extraction Control EC oligonucleotide is used to confirm the validity of the extraction process The EC is dried in the Extraction Tubes and is re hydrated by the BD Viper LT System upon addition of the specimen and extraction reagents At the end of the extraction process the EC fluorescence is monitored by the instrument and an automated algorithm is applied to both the EC and C trachomatis specific signals to report specimen results as positive negative or EC failure QUALITY CONTROL PREPARATION NOTE Do not re hydrate the controls prior to loading in the BD Viper LT Specimen
5. CLSI Wayne PA Morris R et al 1993 Prevalence of isolated urethral asymptomatic Chlamydia trachomatis infection in the absence of cervical infection in incarcerated adolescent girls Sex Transm Dis 20 4 198 200 Paavonen J 1979 Chlamydia trachomatis induced urethritis in female partners of men with nongonococcal urethritis Sex Transm Dis 6 2 69 71 Marrazo J et al 2005 Impact of patient characteristics on performance of nucleic acid amplification tests and DNA probe for detection of Chlamydia trachomatis in women with genital infections J Clin Microbiol 43 2 577 584 Shafer M et al 2003 Comparing first void urine specimens self collected vaginal swabs and endocervical specimens to detect Chlamydia trachomatis and Neisseria gonorrhoeae by nucleic acid amplification test J Clin Microbiol 47 9 4395 4399 Stamm W E 1999 Chlamydia trachomatis infections of the adult p 407 422 In Sexually transmitted diseases K Homes et al eds McGraw Hill New York Shank D N Jensen and D Wolfe 1999 A method to enumerate Chlamydia trachomatis by counting DFA stained elementary bodies on a printed microscope slide Abstr C 378 p 181 In Abstracts of the 99 General Meeting of the American Society of Microbiology ASM Washington D C Herrmann B 2008 Update on the new variant of Chlamydia trachomatis prevalence and diagnostics Eurosurveillance 13 4 6 1 2 Technical Information In the United State
6. Label with patient information and date time collected 12 Transport to laboratory Male Urethral Swab Specimen Collection using Male Urethral Specimen Collection Kit for the BD ProbeTec Q Amplified DNA Assays 1 Remove the swab from packaging 2 Insert the swab 2 4 cm into the urethra and rotate for 3 5 s 3 Withdraw the swab 4 Uncap the Q Swab Diluent tube 5 Fully insert the collection swab into the Q Swab Diluent tube BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure 6 Break the shaft of the swab at the score mark Use care to avoid splashing of contents 7 Tightly recap the tube 8 Label the tube with patient information and date time collected 9 Transport to laboratory Swab Storage and Transport Table 1 provides instructions for storage and transport conditions to the laboratory and or test site for swab specimens The endocervical and the male urethral swab specimens must be stored and transported to the laboratory and or test site within 30 days after collection if kept at 2 30 C or within 180 days after collection if kept frozen at 20 C Patient collected vaginal swab specimens must be stored and transported to the laboratory and or test site within 14 days after collection if kept at 2 30 C or within 180 days after collection if kept frozen at 20 C Patient collected vaginal swab specimens that are expressed in Q Swab Diluent may be store
7. Q Swab Diluent tube to avoid splashing Place the expressed swab back into the transport tube and discard with biohazardous waste Tightly recap the Q Swab Diluent tube with the black pierceable cap Repeat steps 1 6 for additional swab specimens Using the tube layout report place the tube in order in the BD Viper Lysing Rack and lock into place Oe DOF A 30M OTs PS 00 Specimens are ready to be pre warmed 10 Change gloves before proceeding to avoid contamination BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure URINE SPECIMEN PROCESSING NOTE If specimens are refrigerated or frozen make sure they are brought to room temperature and mixed by inversion prior to proceeding Processing procedure for the Q UPT 1 Make sure the urine volume in each Q UPT tube falls between the lines indicated on the tube label Under or over filling the tube may affect assay performance Over filling the tube may also result in liquid overflow on the BD Viper deck and could cause contamination 2 Make sure the Q UPT tube has a black pierceable cap 3 Repeat steps 1 and 2 for additional Q UPT tube specimens 4 Using the tube layout report place the Q UPT tube in order in the BD Viper Lysing Rack and lock into place 5 Specimens are ready to be pre warmed 6 Change gloves before proceeding to avoid contamination Processing procedure for unpreserved Neat urine specimens NOTE We
8. Rack 1 Using the tube layout report scan the CT GC Q Negative Control and place in the appropriate position in the BD Viper LT Specimen Rack Likewise scan the CT GC Q Positive Control and place in the appropriate position in the BD Viper LT Specimen Rack If using the Lighted Login Rack place tube in the position that is lit on the Lighted Login Rack 2 Using the tube layout report place CT GC Q Negative Controls into the appropriate positions in the BD Viper LT Specimen Rack 3 Using the tube layout report place CT GC Q Positive Controls into the appropriate positions in the BD Viper LT Specimen Rack 4 Controls are ready to be pre warmed with the specimens 23 BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure SPECIMEN PROCESSING CONTROLS Specimen Processing Controls may be tested in accordance with the requirements of appropriate accrediting organizations A positive Specimen Processing Control tests the entire assay system For this purpose known positive specimens can serve as controls by being processed and tested in conjunction with unknown specimens Specimens used as processing controls must be stored processed and tested according to the package insert instructions If a known positive specimen is not available additional options for Specimen Processing Controls are described below Preparation of Specimen Processing Controls in BD ProbeTec Q Swab Diluent ATCC Chla
9. a black pierceable cap Repeat steps 1 and 2 for additional Q UPT tube specimens 4 Using the tube layout report scan the Q UPT Tube with black pierceable cap and place in order in the BD Viper LT Specimen Rack If using the Lighted Login Rack place specimen tube in the position that is lit on the Login Rack 5 Specimens are ready to be pre warmed 6 Change gloves before proceeding to avoid contamination 22 BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure Processing procedure for unpreserved Neat urine specimens NOTE Wear clean gloves when handling the urine specimen If gloves come in contact with specimen immediately change them to prevent contamination of other specimens 1 Label a Specimen Tube for use on the BD Viper System Extracted Mode with the patient identification and date time collected 2 Swirl the urine cup to mix the urine specimen and open carefully NOTE Open carefully to avoid spills which may contaminate gloves or the work area 3 Uncap the tube and use a pipette to transfer the urine specimen into the tube The correct volume of urine has been added when the fluid level is between the purple lines on the fill window located on the label This volume corresponds to approximately 2 0 3 0 mL of urine DO NOT overfill or under fill the tube 4 Tighten a black pierceable cap securely on each tube 5 Repeat steps 1 through 4 for each urine specimen Us
10. and male and female urine specimens Performance with other specimen types has not been assessed 2 Optimal performance of the test requires adequate specimen collection and handling Refer to the Specimen Collection and Transport sections of this insert 3 Endocervical specimen adequacy can only be assessed by microscopic visualization of columnar epithelial cells in the specimen 4 Collection and testing of urine specimens with the BD ProbeTec CT Q Amplified DNA Assay is not intended to replace cervical exam and endocervical sampling for diagnosis of urogenital infection Cervicitis urethritis urinary tract infections and vaginal infections may result from other causes or concurrent infections may occur 5 The BD ProbeTec CT Q Amplified DNA Assay for male and female urine specimen testing should be performed on first catch random urine specimens defined as the first 20 60 mL of the urine stream 6 The effects of other potential variables such as vaginal discharge use of tampons douching and specimen collection variables have not been determined 7 A negative test result does not exclude the possibility of infection because test results may be affected by improper specimen collection technical error specimen mix up concurrent antibiotic therapy or the number of organisms in the specimen which may be below the sensitivity of the test 8 As with many diagnostic tests results from the BD ProbeTec CT Q Amplified DNA Assay s
11. cup 3 The patient should collect the first 20 60 mL of voided urine the first part of the stream NOT midstream into a urine collection cup 4 Cap and label with patient identification and date time collected Urine Transfer to Q UPT NOTE Urine specimens should be transferred from the collection cup to the Q UPT within 8 h of collection if the urine specimen has been stored at 2 30 C Urine specimens stored at 2 8 C can be held up to 24 h prior to transfer to the Q UPT Wear clean gloves when handling the Q UPT tube and urine specimen If gloves come in contact with the specimen immediately change them to prevent contamination of other specimens 1 Open the Q UPT Collection and Transport Kit and remove the Q UPT and transfer pipette from their packaging 2 Label the Q UPT with the patient identification and date time collected 3 Hold the Q UPT upright and firmly tap the bottom of the tube on a flat surface to dislodge any large drops from inside the cap Repeat if necessary 4 Uncap the Q UPT and use the transfer pipette to dispense urine into the tube The correct volume of urine has been added when the fluid level is between the purple lines on the fill window located on the Q UPT label This volume corresponds to approximately 2 0 3 0 mL of urine DO NOT overfill or under fill the tube 5 Discard the transfer pipette in a biohazard waste container NOTE The transfer pipette is intended for use
12. section for expected control values Reported results are determined as follows Table 4 Interpretation of Test Results for CT Q Assays another specimen for testing Tube Report CT Q Result MaxRFU Report Interpretation Result Positive for C trachomatis O gt 125 C trachomatis plasmid DNA C trachomatis organism viability and or infectivity Positive detected by SDA cannot be inferred since target DNA may persist in the absence of viable organisms Presumed negative for C trachomatis F A negative result does not preclude C J lt 125 C trachomatis plasmid DNA trachomatis infection because results are Negative not detected by SDA dependent on adequate specimen collection absence of inhibitors and the presence of sufficient DNA to be detected Extraction control failure Repeat test from initial hn Extraction be lt 125 specimen tube or obtain C trachomatis if present not detectable Control Failure another specimen for testing Extraction Transfer Failure Repeat test from initial A Extraction ET Any value specimen tube or obtain C trachomatis if present not detectable Transfer Failure another specimen for testing Liquid Level Failure Repeat test from initial specimen tube eee Liquid Level H Any value or obtain another specimen for C trachomatis if present not detectable Failure testing Error Repeat test from initial 0 Any value specimen tube or obtain C trachomatis if presen
13. with a single specimen 6 Tighten the cap securely on the Q UPT 7 Invert the Q UPT 3 4 times to ensure that the specimen and reagent are well mixed Q UPT Urine Storage and Transport Store and transport Q UPT urine specimens at 2 30 C and pre warm them within 30 days of transfer to the Q UPT Specimens may be stored in the Q UPT at 20 C for up to 180 days prior to pre warming Neat Urine Storage and Transport Store and transport neat urine specimens from the collection site to the test site at 2 8 C and pre warm them within 7 days of collection Neat urine stored at 2 30 C must be pre warmed within 30 h of collection Neat urine specimens may also be stored frozen at 20 C for up to 180 days prior to pre warming 20 BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure Table 18 Urine Specimen Storage and Transport Urine Specimen Type to be Processed Q UPT NEAT Store urine specimen 2 30 C and transfer to Q UPT within 8 h of collection Urine Handling or Options Prior To Store urine specimen 2 8 C and transfer to Q UPT Transtento Q within 24 h of collection UPT or Transfer to Q UPT immediately Process Specimen 4 a A i According to 2 87 2 30 C 20 C 2 87 2 30 C 20 C Instructions Process and as a ast Test Specimen Within 30 days after transfer to Q pela lanes i Within 7 days a p According to UPT x of collecti
14. with the BD Viper LT System 28 Use only the BD Viper SDA Extraction Reagent Trough with Piercing Tool with the BD ProbeTec Chlamydia trachomatis CT Q Amplified DNA Assay Gray Amp Reagent Pack on the BD Viper LT System 29 The BD Viper SDA Extraction Reagent Trough and Piercing Tool contains corrosive substances These solutions have a strong caustic effect and may cause severe burns to skin and mucous membranes DANGER H H302 Harmful if swallowed H314 Causes severe skin burns and eye damage P260 Do not breathe dust fume gas mist vapors spray P280 Wear protective gloves protective clothing eye protection face protection P303 P361 P353 IF ON SKIN or hair Remove take off immediately all contaminated clothing Rinse skin with water shower P304 P340 IF INHALED Remove victim to fresh air and keep at rest in a position comfortable for breathing P405 Store locked up P501 Dispose of contents container in accordance with local regional national international regulations 30 Use only the Clear Plate Seals from the BD Viper LT System SDA Accessory Kit on the Gray Amp plates with the BD Viper LT System Using other seals for sealing the Gray Amp plates may cause erroneous results 31 Reagent pouches containing unused Priming Microwells and Amplification Microwells MUST be carefully resealed after opening Verify that desiccant is present prior to resealing the reagent pouches 32 Because the CT GC Q Positive Control is used for both C
15. 1 The patient should not have urinated for at least 1 h prior to specimen collection 2 Collect the specimen in a sterile preservative free specimen collection cup 3 The patient should collect the first 20 60 mL of voided urine the first part of the stream NOT midstream into a urine collection cup 4 Cap and label with patient identification and date time collected Urine Transfer to Q UPT NOTE Urine specimens should be transferred from the collection cup to the Q UPT within 8 h of collection if the urine specimen has been stored at 2 30 C Urine specimens stored at 2 8 C can be held up to 24 h prior to transfer to the Q UPT Wear clean gloves when handling the Q UPT tube and urine specimen If gloves come in contact with the specimen immediately change them to prevent contamination of other specimens 1 Open the Q UPT Collection and Transport Kit and remove the Q UPT and transfer pipette from their packaging 2 Label the Q UPT with the patient identification and date time collected 3 Hold the Q UPT upright and firmly tap the bottom of the tube on a flat surface to dislodge any large drops from inside the cap Repeat if necessary BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure 4 Uncap the Q UPT and use the transfer pipette to dispense urine into the tube The correct volume of urine has been added when the fluid level is between the purple lines on the f
16. 8081408 05 BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure Kr Supersedes Procedure Prepared by Revision Any modifications to this document are the sole responsibility of the facility This Sample Procedure is not intended as a substitute for your facility procedure manual instrument manual or reagent labeling package insert This Sample Procedure is intended as a model for use by your facility to meet the needs of your laboratory BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure 8081408 05 INTENDED USE The BD ProbeTec Chlamydia trachomatis Q Amplified DNA Assay when tested with either the BD Viper System in Extracted Mode or the BD Viper LT System uses Strand Displacement Amplification technology for the direct qualitative detection of Chlamydia trachomatis DNA in clinician collected female endocervical and male urethral swab specimens patient collected vaginal swab specimens in a clinical setting and male and female urine specimens both UPT and neat The assay is also intended for use with gynecological specimens collected in BD SurePath Preservative Fluid or PreservCyt Solution using an aliquot that is removed prior to processing for either the BD SurePath or ThinPrep Pap test The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogeni
17. BD Viper System TEST PROCEDURE Refer to the BD Viper Instrument User s Manual Extracted Mode Operation for specific instructions for operating and maintaining the components of the system The optimum environmental conditions for the CT Q Assays were found to be 18 27 C and 20 85 Relative Humidity INTEPRETATION OF QUALITY CONTROL RESULTS Interpretation of Quality Control Results The CT GC Q Positive Control and the CT GC Q Negative Control must test as positive and negative respectively in order to obtain patient results If controls do not perform as expected the run is considered invalid and patient results will not be reported by the instrument If either of the controls does not provide the expected results repeat the entire run using a new set of controls new extraction tubes new extraction reagent trough new lysis trough and new microwells If the repeat QC does not provide the expected results contact BD Technical Services If the C trachomatis specific signal is greater than or equal to a threshold of 125 Maximum Relative Fluorescent Units MaxRFU the EC fluorescence is ignored by the algorithm If the C trachomatis specific signal is less than a threshold of 125 MaxRFU the EC fluorescence is utilized by the algorithm in the interpretation of the result Table 3 Interpretation of Quality Control Results Control Type Tube Result Report Symbol CT Q Max RFU QC Disposition CT Q Positive Co
18. Control will monitor for substantial reagent failure only The CT GC Q Negative Control monitors for reagent and or environmental contamination Additional controls may be tested according to guidelines or requirements of local state and or federal regulations or accrediting organizations Refer to CLSI C24 A3 for additional guidance on appropriate internal quality control testing practices 14 The Positive Control contains approximately 2400 copies per mL of pCTB4 and pGCint3 linearized plasmids The Extraction Control EC oligonucleotide is used to confirm the validity of the extraction process The EC is dried in the Extraction Tubes and is re hydrated by the BD Viper System upon addition of the specimen and extraction reagents At the end of the extraction process the EC fluorescence is monitored by the instrument and an automated algorithm is applied to both the EC and C trachomatis specific signals to report specimen results as positive negative or EC failure QUALITY CONTROL PREPARATION NOTE Do not re hydrate the controls prior to loading in the BD Viper Lysing Rack 1 Using the tube layout report place CT GC Q Negative Controls into the appropriate positions in the BD Viper Lysing Rack 2 Using the tube layout report place CT GC Q Positive Controls into the appropriate positions in the BD Viper Lysing Rack 3 Controls are ready to be pre warmed with the specimens if desired SPECIMEN PROCESSING CONTROLS Specimen Processing Cont
19. MC J Andrews R Moore et al 1999 Strand displacement amplification and homogenous real time detection incorporated in a second generation DNA probe system BDProbeTec ET Clin Chem 45 777 784 Hellyer T J J G Nadeau 2004 Strand displacement amplification a versatile tool for molecular diagnostics Expert Rev Mol Diagn 4 251 261 Clinical and Laboratory Standards Institute 2005 Approved Guidelines M29 A3 Protection of laboratory workers from occupationally acquired infections 3 ed CLIS Wayne PA Garner J S 1996 Hospital Infection Control Practices Advisory Committee U S Department of Health and Human Services Centers for Disease Control and Prevention Guideline for isolation precautions in hospitals nfect Control Hospital Epidemiol 1996 17 53 80 U S Department of Health and Human Services 2007 Biosafety in microbiological and biomedical laboratories HHS Publication CDC 5 ed U S Government Printing Office Washington D C Directive 2000 54 EC of the European Parliament and of the Council 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work seventh individual directive within the meaning of Article 16 1 of Directive 89 391 EEC Office Journal L262 17 10 2000 p 0021 0045 Clinical and Laboratory Standards Institute 2006 Approved Guideline C24 A3 Statistical quality control for quantitative measurement procedures principles and definitions 3 ed
20. PETOBE SPECIMEN MALE URETHRAL SWAB pry VAGINAL SWAB SPECIMEN EXPRESSED VAGINAL SWAB PROCESSSED DECINE COLLECTION SITE SPECIMEN TEST SITE Temperature Condition for Transport to 2 30 C 20 C 2 30 C 20 C 2 30 C 20 C Test Site and Storage Process Express and Express and eee ages Specimen Within 30 days of Within 180 days of process within process within i tle wee ie According to collection collection 14 days of 180 days of Sx te Bi abit toe Instructions collection collection P P For U S and international shipments specimens should be labeled in compliance with applicable state federal and international regulations covering the transport of clinical specimens and etiologic agents infectious substances Time and temperature conditions for storage must be maintained during transport BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure URINE SPECIMEN COLLECTION STORAGE AND TRANSPORT For urine specimens performance has been established with the Q UPT and with urine collected in a sterile plastic preservative free specimen collection cup i e neat urine without preservatives Performance with other collection methods and collection devices has not been established Urine Specimen Collection 1 The patient should not have urinated for at least 1 h prior to specimen collection 2 Collect the specimen in a sterile preservative free specimen collection
21. T Q and GC Q testing correct positioning of the microwell strips is important for final results reporting 33 The plate containing the Gray Amp Microwells MUST be properly sealed with the BD Viper LT Clear Plate Sealer prior to moving the plate from the BD Viper LT System Sealing ensures a closed reaction for amplification and detection and is necessary to avoid contamination of the instrument and work area with amplification products Do not remove sealing material from microwells at any time 34 Priming Microwells with residual fluid after transfer of liquid from the Priming Microwells to the Gray Amp Microwells represent a source of target contamination Carefully seal Priming Microwells with BD Viper Black Plate Sealers prior to disposal 35 To prevent contamination of the work environment with amplification products use the disposal bags provided in the BD Viper LT System SDA Accessory Kit to dispose of tested Amplification Microwells Make sure the bags are properly closed before disposal BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure 36 Although dedicated work areas are not required because the BD Viper LT design reduces the possibility of amplicon contamination in the testing environment other precautions for controlling contamination particularly to avoid contamination of specimens during manipulation are necessary 37 CHANGE GLOVES if they come in contact with specimen or appear
22. Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure INTEPRETATION OF TEST RESULTS The BD ProbeTec CT Q Amplified DNA Assay uses fluorescent energy transfer as the detection method to test for the presence of C trachomatis in clinical specimens All calculations are performed automatically by the BD Viper LT software The presence or absence of C trachomatis DNA is determined by calculating the peak fluorescence MaxRFU over the course of the amplification process and by comparing this measurement to a predetermined threshold value The magnitude of the MaxRFU score is not indicative of the level of organism in the specimen If the C trachomatis specific signal is greater than or equal to a threshold of 125 MaxRFU the EC fluorescence is ignored by the algorithm If the C trachomatis specific signal is less than a threshold of 125 MaxRFU the EC fluorescence is utilized by the algorithm in the interpretation of the result If assay control results are not as expected patient results are not reported See the Quality Control section for expected control values Reported results are determined as follows Table 20 Interpretation of Test Results for the CT Q Assays another specimen for testing Tube CT Q Report Report Interpretation Result MaxRFU Result Positive for C trachomatis p 3125 C trachomatis plasmid DNA C trachomatis organism viability and or infe
23. and transport of vaginal swabs use only the Vaginal Specimen Transport for the BD ProbeTec Q Amplified DNA Assays 6 For collection of male urethral swab specimens use only the Male Urethral Specimen Collection Kit for the BD ProbeTec Q Amplified DNA Assays 7 For urine specimens use only the Q UPT or unpreserved neat urine 8 Under or over dispensing of urine into Specimen Tubes or the Q UPT may affect assay performance Over filling the tubes may also result in liquid overflow on the BD Viper deck and could cause contamination 9 For male urethral and female endocervical swab specimens specimens must be collected and tested before the expiration date of the Q Swab Diluent tube 10 For vaginal specimens specimens must be collected and processed before the expiration date of the Vaginal Specimen Transport Once expressed specimens must be tested before the expiration date of the Q Swab Diluent tube 11 For urine specimens specimens must be tested before the expiration date of the Q UPT 12 For liquid based cytology specimens use only the Liquid Based Cytology Specimen LBC Dilution Tube for the BD ProbeTec Q Amplified DNA Assays 13 Liquid based cytology solutions contain flammable substances Do not place specimens transferred to the LBC Specimen Dilution Tubes in the BD Viper Lysing Rack or the Lysing Heater Specimens transferred to the LBC Specimen Dilution Tubes should be placed in the BD Viper LBC Specimen Rack
24. ar clean gloves when handling the urine specimen If gloves come in contact with specimen immediately change them to prevent contamination of other specimens 1 Label a Specimen Tube for use on the BD Viper System Extracted Mode with the patient identification and date time collected 2 Swirl the urine cup to mix the urine specimen and open carefully NOTE Open carefully to avoid spills which may contaminate gloves or the work area 3 Uncap the tube and use a pipette to transfer the urine specimen into the tube The correct volume of urine has been added when the fluid level is between the purple lines on the fill window located on the label This volume corresponds to approximately 2 0 3 0 mL of urine DO NOT overfill or under fill the tube 4 Tighten a black pierceable cap securely on each tube 5 Repeat steps 1 through 4 for each urine specimen Use a new pipette or pipette tip for each sample 6 Using the tube layout report place the neat urine specimens in order in the BD Viper Lysing Rack and lock into place 7 Specimens are ready to be pre warmed 8 Change gloves before proceeding to avoid contamination NOTE The pre warm step must be started within 30 h of collection if the urine has been stored at 2 30 C within 7 days of collection if stored at 2 8 C or within 180 days if stored frozen at 20 C PROCESSING PROCEDURE FOR LBC SPECIMENS TRANSFERRED TO THE LBC SPECIMEN DILUTION TUBES NOTE Do not place
25. ard pipette tip NOTE A separate pipette tip must be used for each specimen 4 Tighten the cap on the LBC Specimen Dilution Tube securely 5 Invert the LBC Specimen Dilution Tube 3 4 times to ensure that the specimen and diluent are well mixed PreservCyt Specimen Transfer NOTE Refer to the ThinPrep 2000 3000 System Operator s Manual Addendum for instructions on removing an aliquot from the PreservCyt specimen vial prior to performing the ThinPrep Pap test 1 Label an LBC Specimen Dilution Tube with patient identification information 2 Remove the cap from the LBC Specimen Dilution Tube 3 Transfer 0 5 mL from the specimen vial to the LBC Specimen Dilution Tube Avoid pipetting fluid from the bottom of the vial Discard pipette tip NOTE A separate pipette tip must be used for each specimen 4 Tighten the cap on the LBC Specimen Dilution Tube securely 5 Invert the LBC Specimen Dilution Tube 3 4 times to ensure that the specimen and diluent are well mixed 21 BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure Storage and Transport of Specimens Transferred to the LBC Specimen Dilution Tubes After transfer to an LBC Specimen Dilution Tube the diluted specimen can be stored at 2 30 C for up to 30 days Diluted specimens may also be stored at 20 C for up to 90 days SWAB SPECIMEN PROCESSING NOTE The optional Lighted Login Rack assists in correct specimen tube pla
26. ated upon addition of the specimen and extraction reagents At the end of the extraction process the EC fluorescence is monitored by the BD Viper LT instrument and an automated algorithm is applied to both the EC and C trachomatis specific signals to report specimen results as positive negative or EC failure REAGENTS Each BD ProbeTec CT Q Assay Gray Amp Reagent Pack contains e CT Q Amplified DNA Assay Priming Microwells 12 x 96 each Priming Microwell contains approximately 110 pmol oligonucleotides 45 pmol fluorescently labeled detector probe 80 nmol dNTPs with stabilizers and buffer components e CT Q Amplified DNA Assay Gray Amplification Microwells 12 x 96 each Amplification Microwell contains approximately 10 units DNA polymerase and 62 units restriction enzyme with stabilizers and buffer components NOTE Each microwell pouch contains one desiccant bag MATERIALS REQUIRED BUT NOT PROVIDED Control Set for the BD ProbeTec CT GC Q Amplified DNA Assays 24 CT GC Q Positive Control Tubes containing approximately 2400 copies each of pCTB4 and pGCint3 linearized plasmids in carrier nucleic acid and 24 CT GC Q Negative Control Tubes containing carrier nucleic acid alone The concentrations of the pCTB4 and pGCint3 plasmids are determined by UV spectrophotometry Swab Diluent for the BD ProbeTec Q Amplified DNA Assays Q Swab Diluent 48 tubes each containing approximately 2 mL of potassium phosphate potassium hydroxide buffer w
27. ation of target DNA without further user intervention For gynecological specimens that are collected and transported in BD SurePath Preservative Fluid or PreservCyt Solution the pre warm step is not necessary i e an aliquot is simply transferred to a Liquid Based Cytology Specimen LBC Dilution Tube for the BD ProbeTec Q Amplified DNA Assays prior to loading on the instrument The specimen is transferred to an Extraction Tube that contains ferric oxide particles in a dissolvable film and dried Extraction Control A high pH is used to lyse the bacterial cells and liberate their DNA into solution Acid is then added to lower the pH and induce a positive charge on the ferric oxide which in turn binds the negatively charged DNA The particles and bound DNA are then pulled to the sides of the Extraction Tube by magnets and the treated specimen is aspirated to waste The particles are washed and a high pH Elution Buffer is added to recover the purified DNA Finally a Neutralization Buffer is used to bring the pH of the extracted solution to the optimum for amplification of the target The BD ProbeTec CT Q Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification primers and a fluorescently labeled detector probe The reagents for SDA are dried in two separate disposable microwells the Priming Microwell contains the amplification primers fluorescently labeled detector probe nucleotides and other rea
28. ay cause erroneous results 28 Reagent pouches containing unused Priming Microwells and Amplification Microwells MUST be carefully resealed after opening Verify that desiccant is present prior to resealing the reagent pouches 29 Because the CT GC Q Positive control is used for both CT Q and GC Q testing correct positioning of the microwell strips is important for final results reporting 30 The plate containing the Amplification Microwells MUST be properly sealed with the BD Viper Amplification Plate Sealer Black prior to moving the plate from the BD Viper System Sealing ensures a closed reaction for amplification and detection and is necessary to avoid contamination of the instrument and work area with amplification products Do not remove sealing material from microwells at any time 31 Priming Microwells with residual fluid after transfer of liquid from the Priming Microwells to the Amplification Microwells represent a source of target contamination Carefully seal Priming Microwells with plate sealer prior to disposal 32 To prevent contamination of the work environment with amplification products use the disposal bags provided in the Accessory kit to dispose of tested Amplification Microwells Make sure the bags are properly closed before disposal 33 Although dedicated work areas are not required because the BD Viper design reduces the possibility of amplicon contamination in the testing environment other precautions for cont
29. by patients at home 22 The performance of vaginal swab specimens has not been evaluated in patients less than 17 years of age 23 The performance of vaginal swab specimens has not been evaluated in pregnant women AVAILABILITY The following BD ProbeTec CT GC Q and BD Viper products for use on the BD Viper LT are also available Cat No Description 440724 BD Viper Pipette Tips 960 441392 BD Viper Trash Box 441391 BD Viper Trash Bags 440818 BD Viper Trash Boxes and Bags 440974 BD Viper Tube Lockdown Cover 440975 BD Viper Lysing Heater 115V 440976 BD Viper Lysing Heater 230V 440977 BD Viper Lysing Rack 440984 Amplification Plate Sealers Black 441072 BD Viper Liquid Waste Bottle 441074 BD Viper Plate Seal Tool 440752 Microwell Package for BD Viper System 441091 BD Viper System 441122 Vaginal Specimen Transport for the BD ProbeTec Q Amplified DNA Assays 100 units 441124 BD ProbeTec GC Q Amplified DNA Assay Reagent Pack 1152 tests 441126 BD ProbeTec CT Q Amplified DNA Assay Reagent Pack 1152 tests 441125 Control Set for the BD ProbeTec CT GC Q Amplified DNA Assays 24 positive and 24 negative 441128 BD Viper Extraction Reagent and Lysis Trough 12 Extraction Reagent Troughs and 12 Lysis Troughs 441129 BD FOX Extraction Tubes 441354 BD Viper Neutralization Pouch 12 pouches 441357 BD ProbeTec Q Collection Kit for Endocervical or Lesion Specimens 100 unit
30. cement during specimen login The Lighted Login Rack is connected to the BD Viper LT instrument Before starting specimen login the Specimen Rack is placed on the Lighted Login Rack As a specimen is logged the assigned location on the rack lights to indicate where to place the tube This continues until all specimens are logged in Processing procedure for the BD ProbeTec Q Collection Kit for Endocervical or Lesion Specimens or the Male Urethral Specimen Collection Kit for the BD ProbeTec Q Amplified DNA Assays NOTE If specimens are refrigerated or frozen make sure they are brought to room temperature and mixed by inversion prior to proceeding 1 Using the tube layout report scan the Q Swab Diluent tube with black pierceable cap and place in order in the BD Viper LT Specimen Rack If using the Lighted Login Rack place specimen tube in the position that is lit on the Lighted Login Rack 2 Repeat step 1 for additional swab specimens 3 Specimens are ready to be pre warmed 4 Change gloves before proceeding to avoid contamination Processing procedure for the Vaginal Specimen Transport for the BD ProbeTec Q Amplified DNA Assays NOTE Wear clean gloves when handling the vaginal swab specimen If gloves come in contact with specimen immediately change them to prevent contamination of other specimens NOTE If specimens are refrigerated or frozen make sure they are brought to room temperature prior to expression 1 Label a pre fille
31. cted 12 Transport to laboratory Vaginal Swab Patient Collection Procedure using Vaginal Specimen Transport for the BD ProbeTec Q Amplified DNA Assays NOTE Ensure that patients read the Patient Collection Instructions before providing them with a collection kit 1 Wash hands with soap and water Rinse and dry 2 Itis important to maintain a comfortable balance during the collection procedure 3 Twist the cap to break the seal Pull the cap with attached swab from the tube Do not touch the soft tip or lay the swab down If you touch or drop the swab tip or the swab is laid down discard the swab and request a new vaginal swab 4 Hold the swab by the cap with one hand so that the swab tip is pointing toward you 5 With your other hand gently spread the skin outside the vagina Insert the tip of the swab into the vaginal opening Point the tip toward your lower back and relax your muscles 6 Gently slide the swab no more than 2 inches into the vagina If the swab does not slide easily gently rotate the swab as you push If it is still difficult do not attempt to continue Make sure the swab touches the walls of the vagina so that moisture is absorbed by the swab 7 Rotate the swab for 10 15s 8 Withdraw the swab without touching the skin Place the swab in the tube and cap securely 9 After collection wash hands with soap and water rinse and dry 10 Return the tube with the swab to the nurse or clinician as instructed 11
32. ctivity Positive detected by SDA cannot be inferred since target DNA may persist in the absence of viable organisms Presumed negative for C trachomatis A negative result does not preclude C J lt 125 C trachomatis plasmid DNA trachomatis infection because results are Negative not detected by SDA dependent on adequate specimen collection absence of inhibitors and the presence of sufficient DNA to be detected Extraction control failure Repeat test from initial _ Extraction be lt 125 specimen tube or obtain C trachomatis if present not detectable Coniirol Failur another specimen for testing Extraction Transfer Failure Repeat test from initial Extraction ef Any value specimen tube or obtain C trachomatis if present not detectable Tranter Failte another specimen for testing Liquid Level Failure Repeat test from initial specimen tube bo Liquid Level H Any value or obtain another specimen for C trachomatis if present not detectable Failure testing Error Repeat test from initial 0 Any value specimen tube or obtain C trachomatis if present not detectable Error BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure MONITORING FOR THE PRESENCE OF DNA CONTAMINATION At least monthly the following test procedure should be performed to monitor the work area and equipment surfaces for the presence of DNA contamination Environmental monitoring is essential to detec
33. d BD ProbeTec Q Swab Diluent tube for each swab specimen to be processed 2 Remove the cap and insert the swab specimen into the Q Swab Diluent Mix by swirling the swab in the Q Swab Diluent for 5 10s Express the swab along the inside of the tube so that liquid runs back into the bottom of the tube Remove the swab carefully from the Q Swab Diluent tube to avoid splashing Place the expressed swab back into the transport tube and discard with biohazardous waste Tightly recap the Q Swab Diluent tube with the black pierceable cap Repeat steps 1 6 for additional swab specimens oN Oa PP Using the tube layout report scan the Q Swab Diluent tube with black pierceable cap and place in order in the BD Viper LT Specimen Rack If using the Lighted Login Rack place specimen tube in the position that is lit on the Lighted Login Rack 9 Specimens are ready to be pre warmed 10 Change gloves before proceeding to avoid contamination URINE SPECIMEN PROCESSING NOTE If specimens are refrigerated or frozen make sure they are brought to room temperature and mixed by inversion prior to proceeding Processing procedure for the Q UPT 1 Make sure the urine volume in each Q UPT tube falls between the lines indicated on the tube label Under or over filling the tube may affect assay performance Over filling the tube may also result in liquid overflow on the BD Viper deck and could cause contamination 2 Make sure the Q UPT tube has
34. d and processed within 30 days after expression if kept at 2 30 C or within 180 days after the date of expression if kept frozen at 20 C Table 1 Swab Specimen Storage and Transport VAGINAL SWAB SPECIMEN Ele FEMALE ENDOCERVICAL SWAB TYPETOBE SPECIMEN MALE URETHRAL SWAB DRY VAGINAL SWAB SPECIMEN EXPRESSED VAGINAL SWAB PROCESSSED BEECIMEN COLLECTION SITE SPECIMEN TEST SITE Temperature Condition for Transport to 2 30 C 20 C 2 30 C 20 C 2 30 C 20 C Test Site and Storage Process Express and Express and zi es Specimen Within 30 days of Within 180 days of process within process within ae seen According to collection collection 14 days of 180 days of os ee a cacti Instructions collection collection p P For U S and international shipments specimens should be labeled in compliance with applicable state federal and international regulations covering the transport of clinical specimens and etiologic agents infectious substances Time and temperature conditions for storage must be maintained during transport URINE SPECIMEN COLLECTION STORAGE AND TRANSPORT For urine specimens performance has been established with the Q UPT and with urine collected in a sterile plastic preservative free specimen collection cup i e neat urine without preservatives Performance with other collection methods and collection devices has not been established Urine Specimen Collection
35. e a new pipette or pipette tip for each sample 6 Using the tube layout report scan the Specimen Tube with black pierceable cap and place in order in the BD Viper LT Specimen Rack If using the Lighted Login Rack place tube in the position that is lit on the Login Rack 7 Specimens are ready to be pre warmed 8 Change gloves before proceeding to avoid contamination NOTE The pre warm step must be started within 30 h of collection if the urine has been stored at 2 30 C within 7 days of collection if stored at 2 8 C or within 180 days if stored frozen at 20 C PROCESSING PROCEDURE FOR LBC SPECIMENS TRANSFERRED TO THE LBC SPECIMEN DILUTION TUBES NOTE If specimens are frozen make sure they are thawed completely at room temperature and mixed by inversion prior to proceeding 1 Make sure the LBC Specimen Dilution Tube has a pierceable cap 2 Using the tube layout report scan the Specimen Tube with black pierceable cap and place in order in the BD Viper LT Specimen Rack If using the Lighted Login Rack place tube in the position that is lit on the Login Rack 3 Specimens are ready to be pre warmed 4 Change gloves prior to proceeding to avoid contamination QUALITY CONTROL Quality control must be performed in accordance with applicable local state and or federal regulations or accreditation requirements and your laboratory s standard Quality Control procedures It is recommended that the user refer to pertinent CLS
36. e event of a spill of extraction reagents BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure SWAB SPECIMEN COLLECTION STORAGE AND TRANSPORT For swab specimens performance data in this package insert have been established with the BD ProbeTec collection kits listed Performance with collection devices other than those listed has not been evaluated e BD ProbeTec Q Collection Kit for Endocervical or Lesion Specimens e Vaginal Specimen Transport for the BD ProbeTec Q Amplified DNA Assays e Male Urethral Specimen Collection Kit for the BD ProbeTec Q Amplified DNA Assays Swab Specimen Collection Endocervical Swab Specimen Collection using BD ProbeTec Q Collection Kit for Endocervical or Lesion Specimens 1 Remove the cleaning swab from packaging 2 Using the polyester fiber tipped cleaning swab with the white shaft remove excess blood and mucus from the cervical os 3 Discard the used cleaning swab 4 Remove the pink collection swab from packaging 5 Insert the collection swab into the cervical canal and rotate for 15 30 s 6 Withdraw the swab carefully Avoid contact with the vaginal mucosa 7 Uncap the Q Swab Diluent tube 8 Fully insert the collection swab into the Q Swab Diluent tube 9 Break the shaft of the swab at the score mark Use care to avoid splashing of contents 10 Tightly recap the tube 11 Label the tube with patient information and date time colle
37. en established with the BD ProbeTec collection kits listed Performance with collection devices other than those listed has not been evaluated e BD ProbeTec Q Collection Kit for Endocervical or Lesion Specimens e Vaginal Specimen Transport for the BD ProbeTec Q Amplified DNA Assays e Male Urethral Specimen Collection Kit for the BD ProbeTec Q Amplified DNA Assays Swab Specimen Collection Endocervical Swab Specimen Collection using BD ProbeTec Q Collection Kit for Endocervical or Lesion Specimens 1 Remove the cleaning swab from packaging 2 Using the polyester fiber tipped cleaning swab with the white shaft remove excess blood and mucus from the cervical os 3 Discard the used cleaning swab 4 Remove the pink collection swab from packaging 5 Insert the collection swab into the cervical canal and rotate for 15 30 s 6 Withdraw the swab carefully Avoid contact with the vaginal mucosa 7 Uncap the Q Swab Diluent tube 8 Fully insert the collection swab into the Q Swab Diluent tube 9 Break the shaft of the swab at the score mark Use care to avoid splashing of contents 10 Tightly recap the tube 11 Label the tube with patient information and date time collected 12 Transport to laboratory Vaginal Swab Patient Collection Procedure using Vaginal Specimen Transport for the BD ProbeTec Q Amplified DNA Assays NOTE Ensure that patients read the Patient Collection Instructions before providing them with a co
38. es These solutions have a strong caustic effect and may cause severe burns to skin and mucous membranes WARNING H302 Harmful if swallowed H314 Causes severe skin burns and eye damage P260 Do not breathe dust fume gas mist vapours spray P264 Wash thoroughly after handling P270 Do not eat drink or smoke when using this product P280 Wear protective gloves protective clothing eye protection face protection P301 P312 IF SWALLOWED Call a POISON CENTER or doctor physician if you feel unwell P301 P330 P331 IF SWALLOWED rinse mouth Do NOT induce vomiting P303 P361 P353 IF ON SKIN or hair Remove take off immediately all contaminated clothing Rinse skin with water shower P304 P340 IF INHALED Remove victim to fresh air and keep at rest in a position comfortable for breathing P305 P351 P338 IF IN EYES Rinse cautiously with water for several minutes Remove contact lenses if present and easy to do Continue rinsing P310 Immediately call a POISON CENTER or doctor physician P312 Call a POISON CENTER or doctor physician if you feel unwell P321 Specific treatment see on this label P330 Rinse mouth P363 Wash contaminated clothing before reuse P405 Store locked up P501 Dispose of contents container in accordance with local regional national international regulations 27 Use only the BD Viper Amplification Plate Sealers Black on the Amplification plates with the BD Viper System Using the clear sealers for sealing the Amplification plates m
39. esult The CT GC Q Positive Control and the CT GC Q Negative Control must test as positive and negative respectively in order to obtain patient results If controls do not perform as expected the run is considered invalid and patient results will not be reported by the instrument If either of the controls does not provide the expected results repeat the entire run using a new set of controls new extraction tubes new extraction reagent trough and new microwells If the repeat QC does not provide the expected results contact BD Technical Services If the C trachomatis specific signal is greater than or equal to a threshold of 125 Maximum Relative Fluorescent Units MaxRFU the EC fluorescence is ignored by the algorithm If the C trachomatis specific signal is less than a threshold of 125 MaxRFU the EC fluorescence is utilized by the algorithm in the interpretation of the result Table 19 Interpretation of Quality Control Results Control Type Tube Result Report Symbol CT Q Max RFU QC Disposition CT Q Positive Control OK 2125 QC Pass CT Q Positive Control DF lt 125 QC Failure CT Q Positive Control Et ai pe ot H 0 Any value QC Failure CT Q Negative Control OK lt 125 QC Pass CT Q Negative Control DF 2125 QC Failure CT Q Negative Control pf e pe ot H oi 0 Any value QC Failure Refer to the Interpretation of Test Results for a description of Tube Result Report symbols 25 BD
40. fied ranges of temperature and time All specimens undergo a pre warm step in the BD Pre warm Heater to dissolve mucus and homogenize the specimen After cooling the specimens are loaded onto the BD Viper LT System which then performs all of the steps involved in extraction and amplification of target DNA without further user intervention For gynecological specimens that are collected and transported in BD SurePath Preservative Fluid or PreservCyt Solution an aliquot is y transferred to a Liquid Based Cytology Specimen LBC Dilution Tube for the BD ProbeTec Q Amplified DNA Assays prior to pre warming the specimen The specimen is transferred to an Extraction Tube that contains ferric oxide particles in a dissolvable film and dried Extraction Control A high pH is used to lyse the bacterial cells and liberate their DNA into solution Acid is then added to lower the pH and induce a positive charge on the ferric oxide which in turn binds the negatively charged DNA The particles and bound DNA are then pulled to the sides of the Extraction Tube by magnets and the treated specimen is aspirated to waste The particles are washed and a high pH Elution Buffer is added to recover the purified DNA Finally a Neutralization Buffer is used to bring the pH of the extracted solution to the optimum for amplification of the target The BD ProbeTec CT Q Amplified DNA Assay is based on the simultaneous amplification and detection of target DNA using amplification pr
41. g approximately 1 7 mL of Tris Sodium Chloride solution and preservative BD FOX Extraction Tubes 48 strips of 8 tubes each containing approximately 10 mg of iron oxide in a dissolvable film and approximately 240 pmol fluorescently labeled Extraction Control oligonucleotide BD Viper Extraction Reagent and Lysis Trough each 4 cavity Extraction Reagent trough contains approximately 16 5 mL Binding Acid 117 mL Wash Buffer 35 mL Elution Buffer and 29 mL Neutralization Buffer with preservative each Lysis Trough contains approximately 11 5 mL Lysis Reagent INSTRUMENT EQUIPMENT AND SUPPLIES Materials Available from BD BD Viper Instrument BD Viper Instrument Plates BD Viper Pipette Tips BD Viper Tip Waste Boxes BD Viper Amplification Plate Sealers Black BD Viper Lysing Heater BD Viper Lysing Rack BD Viper Neutralization Pouches Specimen Tubes and Caps for use on the BD Viper Extracted Mode Urine Preservative Transport for the BD ProbeTec Q Amplified DNA Assays Q UPT BD ProbeTec Q Collection Kit for Endocervical or Lesion Specimens Male Urethral Specimen Collection Kit for the BD ProbeTec Q Amplified DNA Assays Vaginal Specimen Transport for the BD ProbeTec Q Amplified DNA Assays BD ProbeTec Accessories Liquid Based Cytology Specimen LBC Dilution Tube Caps for the BD ProbeTec Q Amplified DNA Assays BD Viper Liquid Based Cytology Specimen Rack Materials Required But Not Available from BD Nitrile gloves 3 w v hydroge
42. gents necessary for amplification while the Amplification Microwell contains the two enzymes a DNA polymerase and a BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure restriction endonuclease that are required for SDA The BD Viper System pipettes a portion of the purified DNA solution from each Extraction Tube into a Priming Microwell to rehydrate the contents After a brief incubation the reaction mixture is transferred to a corresponding pre warmed Amplification Microwell which is sealed to prevent contamination and then incubated in one of the two thermally controlled fluorescent readers The presence or absence of C trachomatis DNA is determined by calculating the peak fluorescence Maximum Relative Fluorescent Units MaxRFU over the course of the amplification process and by comparing this measurement to a predetermined threshold value In addition to the fluorescent probe used to detect amplified C trachomatis target DNA a second fluorescently labeled oligonucleotide is incorporated in each reaction The Extraction Control EC oligonucleotide is labeled with a different dye than that used for detection of the C trachomatis specific target and is used to confirm the validity of the extraction process The EC is dried in the Extraction Tubes and is re hydrated upon addition of the specimen and extraction reagents At the end of the extraction process the EC fluorescence is monitored by the BD V
43. he cap from the LBC Specimen Dilution Tube 3 Transfer 0 5 mL from the specimen vial to the LBC Specimen Dilution Tube Avoid pipetting fluid from the bottom of the vial Discard pipette tip BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure NOTE A separate pipette tip must be used for each specimen 4 Tighten the cap on the LBC Specimen Dilution Tube securely 5 Invert the LBC Specimen Dilution Tube 3 4 times to ensure that the specimen and diluent are well mixed PreservCyt Specimen Transfer NOTE Refer to the ThinPrep 2000 3000 System Operator s Manual Addendum for instructions on removing an aliquot from the PreservCyt specimen vial prior to performing the ThinPrep Pap test 1 Label an LBC Specimen Dilution Tube with patient identification information 2 Remove the cap from the LBC Specimen Dilution Tube 3 Transfer 0 5 mL from the specimen vial to the LBC Specimen Dilution Tube Avoid pipetting fluid from the bottom of the vial Discard pipette tip NOTE A separate pipette tip must be used for each specimen 4 Tighten the cap on the LBC Specimen Dilution Tube securely 5 Invert the LBC Specimen Dilution Tube 3 4 times to ensure that the specimen and diluent are well mixed Storage and Transport of Specimens Transferred to the LBC Specimen Dilution Tubes After transfer to an LBC Specimen Dilution Tube the diluted specimen can be stored at 2 30 C for up to 30 days Dil
44. hly after handling P305 P351 P338 IF IN EYES Rinse cautiously with water for several minutes Remove contact lenses if present and easy to do P302 P352 IF ON SKIN Wash with plenty of soap and water P403 P233 Store in a well ventilated place Keep container tightly closed P501 Dispose of contents container in accordance with local regional national international regulations 22 Use only sample and control tubes with pierceable caps on the BD Viper LT System Do not remove pierceable caps prior to running the instrument Be sure to replace any punctured pierceable caps with new pierceable caps prior to running the instrument 23 Do not interchange or mix kit reagents from kits with different lot numbers 24 The Q Swab Diluent for the BD ProbeTec Q Amplified DNA Assays contains dimethyl sulfoxide DMSO DMSO is harmful by inhalation in contact with skin and if swallowed Avoid contact with eyes In case of contact with eyes rinse immediately with plenty of water and seek medical advice After contact with skin wash immediately with plenty of water 25 Do not test the Q Swab Diluent tube from the Endocervical Lesion or the Male Urethral Specimen Collection Kits if received in the laboratory without the swab present A false negative test result may occur 26 Use only the BD Viper LT pipette tips as supplied by BD with the BD Viper LT System 27 Use only Gray Amp Microwells as supplied in the BD ProbeTec CT Q Assay Gray Amp Reagent Pack
45. hould be interpreted in conjunction with other laboratory and clinical data available to the physician The BD ProbeTec CT Q Amplified DNA Assay does not detect plasmid free variants of C trachomatis 10 The BD ProbeTec CT Q Amplified DNA Assay should not be used for the evaluation of suspected sexual abuse or for other medico legal indications Additional testing is recommended in any circumstance when false positive or false negative results could lead to adverse medical social or psychological consequences 11 The BD ProbeTec CT Q Amplified DNA Assay cannot be used to assess therapeutic success or failure since nucleic acids from C trachomatis may persist following antimicrobial therapy 12 The BD ProbeTec CT Q Amplified DNA Assay provides qualitative results No correlation can be drawn between the magnitude of the positive assay signal MaxRFU and the number of cells in an infected sample 13 The predictive value of an assay depends on the prevalence of the disease in any particular population See Table 5 for hypothetical predictive values when testing varied populations 14 Because the Positive Control for the BD ProbeTec CT GC Q Amplified DNA Assays is used in testing for both C trachomatis and N gonorrhoeae correct positioning of the microwell strips is important for final results reporting 15 Use of the BD ProbeTec CT Q Amplified DNA Assay is limited to personnel who have been trained in the assay procedure and the BD Vi
46. ia trachomatis LGV Bio Rad AmpliTrol CT GC is available from Bio Rad Laboratories Blackhawk Biosystems 12945 Alcosta Blvd 2 Floor San Ramon CA 94583 1 800 866 0305 AmpliTrol CT GC 00126 29 BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure REFERENCES 1 12 13 14 15 20 21 World Health Organization 2001 Global prevalence and incidence of selected curable sexually transmitted infections overview and estimates WHO Centers for Disease Control and Prevention STD surveillance 2006 national profile http www cdc gov std stats chlamydia htm US Preventative Services Task Force 2001 Screening of chlamydial infection recommendations and rationale Am J Prev Med 20 3S 90 94 Centers for Disease Control and Prevention 2006 Sexually transmitted diseases treatment guidelines 2006 MMWR 55 RR 11 1 94 Advisory Committee for HIV and STD Prevention 1998 HIV prevention through early detection and treatment of other sexually transmitted diseases United States MMWR 47 RR 12 1 24 Centers for Disease Control and Prevention 2002 Screening tests to detect Chlamydia trachomatis and Neisseria gonorrhoeae infections 2002 MMWR 51 RR 15 L 1 40 Essig A 2007 Chlamydia and Chlamydophila In PR Murray EJ Baron ML Landry JH Jorgensen and MA Pfaller eds Manual of clinical microbiology 9 Edition ASM Press Little
47. ient sample is C1 For plate two full plate the last two positions G12 and H12 are reserved for the positive G12 and negative H12 controls respectively For plate two partial plate the last two positions after the last patient sample are automatically assigned as the positive and negative controls respectively BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure PRE WARM PROCEDURE FOR SWAB AND URINE SPECIMENS NOTE The pre warm procedure must be applied to all swab and urine specimens to ensure that the specimen matrix is homogenous prior to loading on the BD Viper System Failure to pre warm specimens may have an adverse impact on the performance of the BD ProbeTec CT GC Q Assays and or BD Viper System Swabs and urine specimens must be pre warmed however pre warming of the controls is optional NOTE Refrigerated or frozen specimens must be brought to room temperature prior to pre warming 1 Insert the BD Viper Lysing Rack into the BD Viper Lysing Heater 2 Pre warm the specimens for 15 min at 114 C 2 C 3 Remove the Lysing Rack from the Lysing Heater and let specimens cool at room temperature for a minimum of 15 min before loading into the BD Viper instrument 4 Refer to the Test Procedure for testing specimens and controls 5 After pre warming specimens may be stored for 7 days at 2 30 C or for 180 days at 20 C without additional pre warming prior to testing on the
48. ill window located on the Q UPT label This volume corresponds to approximately 2 0 3 0 mL of urine DO NOT overfill or under fill the tube 5 Discard the transfer pipette in a biohazard waste container NOTE The transfer pipette is intended for use with a single specimen 6 Tighten the cap securely on the Q UPT 7 Invert the Q UPT 3 4 times to ensure that the specimen and reagent are well mixed Q UPT Urine Storage and Transport Store and transport Q UPT urine specimens at 2 30 C and pre warm them within 30 days of transfer to the Q UPT Specimens may be stored in the Q UPT at 20 C for up to 180 days prior to pre warming Neat Urine Storage and Transport Store and transport neat urine specimens from the collection site to the test site at 2 8 C and pre warm them within 7 days of collection Neat urine stored at 2 30 C must be pre warmed within 30 h of collection Neat urine specimens may also be stored frozen at 20 C for up to 180 days prior to pre warming Table 2 Urine Specimen Storage and Transport Urine Specimen Type to be Processed Q UPT NEAT Store urine specimen 2 30 C and transfer to Q UPT within 8 h of collection Urine Handling or Options Prior Store urine specimen 2 8 C and transfer to Q UPT within To Transfer to 24 h of collection Q UPT or Transfer to Q UPT immediately Process Specimen According to 2 8 C 2 30 C 20 C 2 8 2 30 C 20
49. imers and a fluorescently labeled detector probe The reagents for SDA are dried in two separate disposable microwells the Priming Microwell contains the amplification primers fluorescently labeled detector probe nucleotides and other reagents necessary for amplification while the Gray Amplification Microwell contains the two enzymes a DNA polymerase and a restriction endonuclease that are required for SDA The BD Viper LT System pipettes a portion of the purified DNA solution from each Extraction Tube into a Priming Microwell to rehydrate the contents After a brief incubation the reaction mixture is transferred to a corresponding pre warmed Gray Amplification Microwell which is sealed to prevent contamination and then incubated in a thermally controlled fluorescent reader The presence or absence of C trachomatis DNA is determined by calculating the peak fluorescence Maximum Relative Fluorescent Units MaxRFU over the course of the amplification process and by comparing this measurement to a predetermined threshold value In addition to the fluorescent probe used to detect amplified C trachomatis target DNA a second fluorescently labeled oligonucleotide is incorporated in each reaction The Extraction Control EC oligonucleotide is labeled with a different dye than that used for detection of the C trachomatis specific target and is used to confirm the validity of the extraction process The EC is dried in the Extraction Tubes and is re hydr
50. in the BD Viper LBC Specimen Rack and lock into place 4 Specimen Processing Controls are ready to be tested on the BD Viper System in Extracted Mode 5 Change gloves prior to proceeding to avoid contamination General QC Information for the BD Viper System The location of the microwells is shown in a color coded plate layout screen on the LCD Monitor The plus symbol within the microwell indicates the positive QC sample The minus symbol within the microwell indicates the negative QC sample A QC pair must be logged in for each reagent kit lot number and for each plate to be tested If QC pairs have not been properly logged in a message box appears that prevents saving the rack and proceeding with the run until complete A maximum of two QC pairs per rack is permitted Additional control materials may be added provided they are logged in as samples NOTE The BD Viper System will re hydrate the controls during the assay run Do not attempt to hydrate the assay controls prior to loading them into the BD Viper Lysing Rack Running one plate on a BD Viper System The first two positions A1 and B1 are reserved for the positive A1 and negative B1 controls respectively The first available position for a patient sample is C1 Running two plates on a BD Viper System For plate one the first two positions A1 and B1 are reserved for the positive A1 and negative B1 controls respectively The first available position for a pat
51. iper instrument and an automated algorithm is applied to both the EC and C trachomatis specific signals to report specimen results as positive negative or EC failure REAGENTS Each BD ProbeTec CT Q Reagent Pack contains e CT Q Amplified DNA Assay Priming Microwells 12 x 96 each Priming Microwell contains approximately 110 pmol oligonucleotides 45 pmol fluorescently labeled detector probe 80 nmol dNTPs with stabilizers and buffer components e CT Q Amplified DNA Assay Amplification Microwells 12 x 96 each Amplification Microwell contains approximately 10 units DNA polymerase and 62 units restriction enzyme with stabilizers and buffer components NOTE Each microwell pouch contains one desiccant bag MATERIALS REQUIRED BUT NOT PROVIDED Control Set for the BD ProbeTec CT GC Q Amplified DNA Assays 24 CT GC Q Positive Control Tubes containing approximately 2400 copies each of pCTB4 and pGCint3 linearized plasmids in carrier nucleic acid and 24 CT GC Q Negative Control Tubes containing carrier nucleic acid alone The concentrations of the pCTB4 and pGCint3 plasmids are determined by UV spectrophotometry Q Swab Diluent for the BD ProbeTec Q Amplified DNA Assays 48 tubes each containing approximately 2 mL of potassium phosphate potassium hydroxide buffer with DMSO and preservative Liquid Based Cytology Specimen LBC Dilution Tube for the BD ProbeTec Q Amplified DNA Assays LBC Specimen Dilution Tube 400 tubes each containin
52. ith DMSO and preservative Liquid Based Cytology Specimen LBC Dilution Tubes for the BD ProbeTec Q Amplified DNA Assays LBC Specimen Dilution Tube 400 tubes each containing approximately 1 7 mL of Tris Sodium Chloride solution and preservative BD FOX Extraction Tubes 48 strips of 8 tubes each containing approximately 10 mg of iron oxide in a dissolvable film and approximately 240 pmol fluorescently labeled Extraction Control oligonucleotide BD Viper SDA Extraction Reagent Trough with Piercing Tool 5 cavity Extraction Reagent trough contains approximately 11 5 mL Lysis Reagent 16 5 mL Binding Acid 72 5 mL Wash Buffer 25 4 mL Elution Buffer and 19 4 mL Neutralization Buffer with preservative BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure INSTRUMENT EQUIPMENT AND SUPPLIES Materials Available from BD BD Viper LT Instrument BD Viper Instrument Plates BD Viper LT Amplification Plate Carriers BD Viper LT Pipette Tips BD Viper LT Solid Waste Liners BD Viper LT Waste Bottle BD Viper LT Clear Plate Sealers BD Viper Black Plate Sealers BD Pre warm Heater BD Viper LT Specimen Rack BD Viper LT Extraction Rack BD Viper Neutralization Pouches Specimen Tubes and Caps for use on the BD Viper System Extracted Mode Urine Preservative Transport for the BD ProbeTec Q Amplified DNA Assays Q UPT BD ProbeTec Q Collection Kit for Endocervical or Lesion Specimens Male Urethral Specimen Col
53. l Specimen 4 For collection of endocervical swab specimens use only the BD ProbeTec Q Collection Kit for Endocervical or Lesion Specimens 5 For patient collection and transport of vaginal swabs use only the Vaginal Specimen Transport for the BD ProbeTec Q Amplified DNA Assays 6 For collection of male urethral swab specimens use only the Male Urethral Specimen Collection Kit for the BD ProbeTec Q Amplified DNA Assays 7 For urine specimens use only the Q UPT or unpreserved neat urine 8 Under or over dispensing of urine into Specimen Tubes or the Q UPT may affect assay performance Over filling the tube may also result in liquid overflow on the BD Viper LT deck and could cause contamination 9 For male urethral and female endocervical swab specimens specimens must be collected and tested before the expiration date of the Q Swab Diluent tube 10 For vaginal specimens specimens must be collected and processed before the expiration date of the Vaginal Specimen Transport Once expressed specimens must be tested before the expiration date of the Q Swab Diluent tube 11 For urine specimens specimens must be tested before the expiration date of the Q UPT 12 For liquid based cytology specimens use only the Liquid Based Cytology Specimen LBC Dilution Tube for the BD ProbeTec Q Amplified DNA Assays 13 Liquid based cytology solutions contain flammable substances 14 For testing with the BD ProbeTec CT GC Q Amp
54. lection Kit for the BD ProbeTec Q Amplified DNA Assays 1 Remove the swab from packaging Insert the swab 2 4 cm into the urethra and rotate for 3 5 s Withdraw the swab Uncap the Q Swab Diluent tube Fully insert the collection swab into the Q Swab Diluent tube Break the shaft of the swab at the score mark Use care to avoid splashing of contents Tightly recap the tube Label the tube with patient information and date time collected MP Noap wOD Transport to laboratory Swab Storage and Transport Table 17 provides instructions for storage and transport conditions to the laboratory and or test site for swab specimens The endocervical and the male urethral swab specimens must be stored and transported to the laboratory and or test site within 30 days after collection if kept at 2 30 C or within 180 days after collection if kept frozen at 20 C Patient collected vaginal swab specimens must be stored and transported to the laboratory and or test site within 14 days after collection if kept at 2 30 C or within 180 days after collection if kept frozen at 20 C Patient collected vaginal swab specimens that are expressed in Q Swab Diluent may be stored and processed within 30 days after expression if kept at 2 30 C or within 180 days after the date of expression if kept frozen at 20 C Table 17 Swab Specimen Storage and Transport VAGINAL SWAB SPECIMEN Rieti FEMALE ENDOCERVICAL SWAB TY
55. lection Kit for the BD ProbeTec Q Amplified DNA Assays Vaginal Specimen Transport for the BD ProbeTec Q Amplified DNA Assays BD Viper LT System SDA Accessory Kit Materials Required But Not Available from BD Nitrile gloves 3 w v hydrogen peroxide 1 v v sodium hypochlorite DNA AWAY Chlamydia trachomatis ATCC VR 879 Serovar H or VR 902B LGV II diluted in phosphate buffered saline or Bio Rad AmpliTrol CT GC displacement pipettes polypropylene aerosol resistant pipette tips capable of delivering 0 5 0 05 mL molecular biology nuclease free water and a vortex mixer Do not use hydrogen peroxide from a bottle that has remained open for longer than 8 days Prepare fresh daily Storage and Handling Requirements Reagents may be stored at 2 33 C Unopened Reagent Packs are stable until the expiration date Once a pouch is opened the microwells are stable for 6 weeks if properly sealed or until the expiration date whichever comes first Do not freeze WARNINGS AND PRECAUTIONS General 1 For in vitro Diagnostic Use 2 Pathogenic microorganisms including hepatitis viruses and Human Immunodeficiency Virus may be present in clinical specimens Standard Precautions and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids 3 For additional specific warnings cautions and notes specific to the BD Viper LT consult the BD Viper LT System User s Manua
56. lified DNA Assay on the BD Viper LT System be sure to obtain aliquots of specimens collected in BD SurePath Preservative Fluid or PreservCyt Solution prior to processing for either the BD SurePath or ThinPrep Pap test Failure to do so may result in erroneous results 15 The BD ProbeTec CT GC Q Amplified DNA Assay may not be used with BD SurePath or PreservCyt residual specimens 16 Do not run PreservCyt specimens that have been treated with glacial acetic acid on the BD Viper LT System Extraction Control failures or False Negative results may occur 17 Use only polypropylene aerosol resistant pipette tips to transfer specimens to the LBC Specimen Dilution Tube 18 Liquid based cytology specimens must be tested before the expiration date of the LBC Specimen Dilution Tube 19 Specimens should not be pre warmed more than two times BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure Assay Reagent 20 This reagent pack is for testing endocervical and patient collected vaginal swabs in a clinical setting male urethral swabs male and female urine specimens and BD SurePath and PreservCyt specimens with the BD Viper LT System 21 The Q UPT contains NAP Guard approximately 742 5 mM K EDTA WARNING H315 Causes skin irritation H319 Causes serious eye irritation H355 May cause respiratory irritation P280 Wear protective gloves protective clothing eye protection face protection P264 Wash thoroug
57. llection kit 1 Wash hands with soap and water Rinse and dry 2 Itis important to maintain a comfortable balance during the collection procedure 3 Twist the cap to break the seal Pull the cap with attached swab from the tube Do not touch the soft tip or lay the swab down If you touch or drop the swab tip or the swab is laid down discard the swab and request a new vaginal swab 4 Hold the swab by the cap with one hand so that the swab tip is pointing toward you 5 With your other hand gently spread the skin outside the vagina Insert the tip of the swab into the vaginal opening Point the tip toward your lower back and relax your muscles BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure 6 Gently slide the swab no more than 2 inches into the vagina If the swab does not slide easily gently rotate the swab as you push If it is still difficult do not attempt to continue Make sure the swab touches the walls of the vagina so that moisture is absorbed by the swab 7 Rotate the swab for 10 15 s 8 Withdraw the swab without touching the skin Place the swab in the tube and cap securely 9 After collection wash hands with soap and water rinse and dry 10 Return the tube with the swab to the nurse or clinician as instructed 11 Label with patient information and date time collected 12 Transport to laboratory Male Urethral Swab Specimen Collection using Male Urethral Specimen Col
58. mydia trachomatis 1 Thaw a vial of C trachomatis LGV II or C trachomatis serovar H cells received from ATCC 2 Prepare 10 fold serial dilutions to a 10 dilution at least 4 mL final volume in phosphate buffered saline PBS 3 Place 0 1 mL of the 10 dilution in a BD ProbeTec Q Swab Diluent tube and tightly recap using a black pierceable cap 4 Using the tube layout report place the Specimen Processing Control s in order in the BD Viper LT Specimen Rack and lock into place 5 Process the controls according to the Pre warm Procedure and then follow the Test Procedure 6 Specimen Processing Controls are ready to be tested on the BD Viper LT System 7 Change gloves prior to proceeding to avoid contamination Bio Rad AmpliTrol Chlamydia trachomatis amp Neisseria gonorrhoeae NOTE Refer to manufacturer s processing instructions 1 Add the appropriate volume of Bio Rad AmpliTro CT GC to a BD ProbeTec Q Swab Diluent tube and tightly recap using a black pierceable cap 2 Mix the solution by vortexing or with inversion 3 Using the tube layout report place the Specimen Processing Control s in order in the BD Viper LT Specimen Rack 4 Process the controls according to the Pre warm Procedure and then follow the Test Procedure 5 Specimen Processing Controls are ready to be tested on the BD Viper LT System 6 Change gloves prior to proceeding to avoid contamination Preparation of Specimen Processing Controls in LBC S
59. n peroxide 1 v v sodium hypochlorite DNA AWAY Chlamydia trachomatis ATCC VR 879 Serovar H or VR 902B LGV II diluted in phosphate buffered saline or Bio Rad AmpliTrol CT GC displacement pipettes polypropylene aerosol resistant pipette tips capable of delivering 0 5 0 05 mL and a vortex mixer Do not use hydrogen peroxide from a bottle that has remained open for longer than 8 days Prepare fresh daily Storage and Handling Requirements Reagents may be stored at 2 33 C Unopened Reagent Packs are stable until the expiration date Once a pouch is opened the microwells are stable for 6 weeks if properly sealed or until the expiration date whichever comes first Do not freeze BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure Warnings and Precautions General 1 For in vitro Diagnostic Use 2 Pathogenic microorganisms including hepatitis viruses and Human Immunodeficiency Virus may be present in clinical specimens Standard Precautions and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids 3 For additional specific warnings cautions and notes specific to the BD Viper System consult the BD Viper System User s Manual Specimen 4 For collection of endocervical swab specimens use only the BD ProbeTec Q Collection Kit for Endocervical or Lesion Specimens 5 For patient collection
60. ner Staging Area Locking Plate and Fixed Metal Base Accessories Tube Lockdown cover BD Viper Lysing Rack Table Base BD Viper Lysing Heater Metal Microwell Plates Timer Laboratory Bench Surfaces If an area gives a positive result or if contamination is suspected clean the area with fresh 1 v v sodium hypochlorite DNA AWAY or 3 w v hydrogen peroxide Do not use hydrogen peroxide from a bottle that has remained open for longer than 8 days Make sure the entire area is wetted with the solution and allowed to remain on the surface for at least 2 min or until dry If necessary remove excess cleaning solution with a clean towel Wipe the area with a clean towel saturated with water and allow the surface to dry Retest the area Repeat cleaning process until negative results are obtained If the contamination does not resolve contact BD Technical Service and Support for additional information BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure BD VIPER LT SYSTEM PRINCIPLES OF THE PROCEDURE The BD ProbeTec CT Q Amplified DNA Assay Gray Amp Reagent Pack is designed for use with the BD ProbeTec Chlamydia trachomatis Neisseria gonorrhoeae CT GC Q specimen collection and transport devices applicable reagents the BD Viper LT System and BD FOX Extraction Specimens are collected and transported in their respective transport devices which preserve the integrity of C trachomatis DNA over the speci
61. ntion in the HIV epidemic In order to prevent complications and reduce transmission the US Preventive Services Task Force has also published recommendations for screening young sexually active women and those who are older and considered at increased risk of infection The Chlamydiaceae are gram negative obligate intracellular bacteria that form characteristic intracellular inclusions which can be observed in cell culture by fluorescence microscopy after antigen specific staining is applied Fifteen serovars of C trachomatis are recognized comprising three groups each of which is associated with a different disease state the trachoma serovars A C the occulogenital serovars D K and the Lymphogranuloma venereum serovars L1 L3 Current methods for diagnosis of C trachomatis infection include culture and immunological assays as well as the detection of nucleic acids by direct hybridization or amplification Although historically culture has been the gold standard for detection of C trachomatis the enhanced sensitivity of amplified methods has led to their increasing adoption and in turn contributed to the rise in the number of reported cases of infection This Sample Procedure is not indicated as a substitute for your facility procedure manual instrument manual or reagent labeling package insert This Sample Procedure is intended as a model for use by your facility to be customized to meet the needs of your laboratory
62. ntrol OK gt 125 QC Pass CT Q Positive Control DF lt 125 QC Failure CT Q Positive Control ET 2 Hr 0 Any value QC Failure CT Q Negative Control OK lt 125 QC Pass CT Q Negative Control DF 2125 QC Failure CT Q Negative Control pf or pe or Ki ar 0 Any value QC Failure Refer to the Interpretation of Test Results for a description of Tube Result Report symbols BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure INTEPRETATION OF TEST RESULTS The BD ProbeTec CT Q Amplified DNA Assay uses fluorescent energy transfer as the detection method to test for the presence of C trachomatis in clinical specimens All calculations are performed automatically by the BD Viper software The presence or absence of C trachomatis DNA is determined by calculating the peak fluorescence MaxRFU over the course of the amplification process and by comparing this measurement to a predetermined threshold value The magnitude of the MaxRFU score is not indicative of the level of organism in the specimen If the C trachomatis specific signal is greater than or equal to a threshold of 125 MaxRFU the EC fluorescence is ignored by the algorithm If the C trachomatis specific signal is less than a threshold of 125 MaxRFU the EC fluorescence is utilized by the algorithm in the interpretation of the result If assay control results are not as expected patient results are not reported See the Quality Control
63. ol s in order in the BD Viper LT Specimen Rack Process the controls according to the Pre warm Procedure and then follow the Test Procedure Specimen Processing Controls are ready to be tested on the BD Viper LT System oak oD Change gloves prior to proceeding to avoid contamination 24 BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure General QC Information for the BD Viper LT System The location of the microwells is shown in a color coded plate layout screen on the LCD Monitor The plus symbol within the microwell indicates the positive QC sample The minus symbol within the microwell indicates the negative QC sample A QC pair must be logged in for each reagent kit lot number If QC pairs have not been properly logged in a message box appears that prevents saving the rack and proceeding with the run until complete A maximum of two QC pairs per rack is permitted Additional optional QC tubes for testing may be logged in These tubes are tested as regular samples and do not affect the Pass Fail status of the run Refer to the BD Viper LT System User s Manual for instructions NOTE The BD Viper LT System will re hydrate the controls during the assay run Do not attempt to hydrate the assay controls prior to loading them into the BD Viper LT Specimen Rack PRE WARM PROCEDURE SPECIMENS AND CONTROLS NOTE The pre warm procedure must be applied to all specimens to ensure that the s
64. on 2 Instructions Q UPT collection collection LBC SPECIMEN COLLECTION STORAGE AND TRANSPORT BD SurePath or PreservCyt specimens must be collected using either an endocervical broom or a brush spatula combination as described in the BD SurePath or PreservCyt product insert Once collected BD SurePath or PreservCyt specimens can be stored and transported in their original vials for up to 30 days at 2 30 C prior to transfer to LBC Specimen Dilution Tubes Specimen Transfer to LBC Specimen Dilution Tubes A 0 5 mL aliquot of either the BD SurePath or PreservCyt specimen must be transferred from the original vial to the LBC Specimen Dilution Tube prior to processing for either the BD SurePath or ThinPrep Pap test Wear gloves when handling the LBC Specimen Dilution Tube and the BD SurePath or PreservCyt specimen vial If gloves come in contact with the specimen immediately change them to prevent contamination of other specimens BD SurePath Specimen Transfer NOTE Refer to the BD PrepStain Slide Processor Product Insert for instructions on removing an aliquot from the BD SurePath specimen vial prior to performing the BD SurePath liquid based Pap test 1 Label an LBC Specimen Dilution Tube with patient identification information 2 Remove the cap from the LBC Specimen Dilution Tube 3 Transfer 0 5 mL from the specimen vial to the LBC Specimen Dilution Tube Avoid pipetting fluid from the bottom of the vial Disc
65. ove contact lenses if present and easy to do P302 P352 IF ON SKIN Wash with plenty of soap and water P403 P233 Store in a well ventilated place Keep container tightly closed P501 Dispose of contents container in accordance with local regional national international regulations 2 e Use only sample and control tubes with pierceable caps on the BD Viper System in Extracted Mode Do not remove pierceable caps prior to running the instrument Be sure to replace any punctured pierceable caps with new pierceable caps prior to running the instrument BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure 22 Do not interchange or mix kit reagents from kits with different lot numbers 23 The Q Swab Diluent for the BD ProbeTec Q Amplified DNA Assays contains dimethyl sulfoxide DMSO DMSO is harmful by inhalation in contact with skin and if swallowed Avoid contact with eyes In case of contact with eyes rinse immediately with plenty of water and seek medical advice After contact with skin wash immediately with plenty of water 24 Do not test the Q Swab Diluent tube from the Endocervical Lesion or the Male Urethral Specimen Collection Kits if received in the laboratory without the swab present A false negative test result may occur 25 Use only the BD Viper pipette tips as supplied by BD with the BD Viper System 26 The BD Viper Extraction Reagent and Lysis Troughs contain corrosive substanc
66. overnight on chocolate agar plates Resuspend N gonorrhoeae colonies in PBS Prepare a McFarland 1 turbidity standard from the resuspended colonies Prepare 10 fold serial dilutions of the McFarland 1 suspension to 10 NO Fw LD Add 0 1 mL of 10 dilution of C trachomatis and 0 1 mL of 10 dilution of N gonorrhoeae to an LBC Specimen Dilution Tube containing 0 5 mL of BD SurePath Preservative Fluid or PreservCyt Solution Tightly recap the LBC Specimen Dilution Tube using the blue pierceable cap 8 Invert the LBC Specimen Dilution Tube 3 4 times to ensure that the contents are well mixed 9 Using the tube layout report place the Specimen Processing Control s in order in the BD Viper LBC Specimen Rack and lock into place 10 Specimen Processing Controls are ready to be tested on the BD Viper System in Extracted Mode 11 Change gloves prior to proceeding to avoid contamination Bio Rad AmpliTrol Chlamydia trachomatis and Neisseria gonorrhoeae NOTE Refer to manufacturer s processing instructions 1 Add the appropriate volume of Bio Rad AmpliTrol CT GC to an LBC Specimen Dilution Tube containing 0 5 mL of BD SurePath Preservative Fluid or PreservCyt Solution Tightly recap the LBC Specimen Dilution Tube using the blue pierceable cap 2 Invert the LBC Specimen Dilution Tube 3 4 times to ensure that the contents are well mixed 3 Using the tube layout report place the Specimen Processing Control s in order
67. pecimen Dilution Tubes ATCC Chlamydia trachomatis 1 Thaw a vial of C trachomatis LGV2 or C trachomatis serovar H cells received from ATCC 2 Prepare 10 fold serial dilutions to a 10 dilution at least 4 mL final volume in phosphate buffered saline PBS 3 Place 0 1 mL of 10 dilution in an LBC Specimen Dilution Tube containing 0 5 mL of BD SurePath Preservative Fluid or PreservCyt solution Tightly recap the LBC Specimen Dilution Tube using the blue pierceable cap 4 Invert the LBC Specimen Dilution Tube 3 4 times to ensure that the contents are well mixed 5 Using the tube layout report place the Specimen Processing Control s in order in the BD Viper LT specimen Rack 6 Process the controls according to the Pre warm Procedure and then follow the Test Procedure 7 Specimen Processing Controls are ready to be tested on the BD Viper LT System 8 Change gloves prior to proceeding to avoid contamination Bio Rad AmpliTrol Chlamydia trachomatis and Neisseria gonorrhoeae NOTE Refer to manufacturer s processing instructions 1 Add the appropriate volume of Bio Rad AmpliTrol CT GC to an LBC Specimen Dilution Tube containing 0 5 mL of BD SurePath Preservative Fluid or PreservCyt solution Tightly recap the LBC specimen Dilution Tube using the blue pierceable cap Invert the LBC Specimen Dilution Tube 3 4 times to ensure that the contents are well mixed Using the tube layout report place the Specimen Processing Contr
68. pecimen matrix is homogeneous prior to loading on the BD Viper LT System Failure to pre warm specimens may have an adverse impact on performance of the BD ProbeTec CT GC Q assays and or BD Viper LT System NOTE Refrigerated or frozen specimens must be brought to room temperature prior to pre warming 1 Insert the BD Viper LT Specimen Rack into the BD Pre warm Heater The BD Pre warm Heater scanner reads the specimen rack barcode and begins the appropriate heating and cooling protocol 2 When the Instrument indicates that the pre warm cycle is complete remove the BD Viper LT Specimen Rack from the BD Pre warm Heater and load into the BD Viper LT instrument 3 Refer to the Test Procedure for testing specimens and controls 4 After pre warming urine and swab specimens may be stored for up to 7 days at 2 30 C or up to 180 days at 20 C without additional pre warming prior to testing on the BD Viper LT System LBC specimens that have been pre warmed may be stored for up to 7 days at 2 30 C or up to 90 days at 20 C without additional pre warming prior to testing on the BD Viper LT System TEST PROCEDURE Refer to the BD Viper LT User s Manual for specific instructions for operating and maintaining the components of the system The optimum environmental conditions for the CT Q Assays were found to be 18 27 C and 20 85 Relative Humidity INTEPRETATION OF QUALITY CONTROL RESULTS Interpretation of Quality Control R
69. per System 16 The reproducibility of the BD ProbeTec CT Q Amplified DNA Assay was established using seeded simulated swabs and seeded Q Swab Diluent to simulate urine specimens These specimens were inoculated with either C trachomatis alone or C trachomatis plus N gonorrhoeae 17 Performance has not been established for urine specimens in Q UPT when fill volumes other than those falling within the purple lines on the fill window approximately 2 0 mL to 3 0 mL are used 27 BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure 18 The performance of the BD ProbeTec CT Q Amplified DNA Assay on the BD Viper System in extracted mode with swab specimens was evaluated for interference by blood gynecological lubricants and spermicides The performance with urine specimens was evaluated for interference by blood and commonly used over the counter pain relievers No interference was observed with any of the substances at the concentrations tested 19 The patient collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated 20 The patient collected vaginal swab specimen application is limited to healthcare facilities where support counseling is available to explain procedures and precautions 21 The BD ProbeTec CT Q Amplified DNA Assay has not been validated for vaginal swab specimens collected
70. pierceable cap 2 Mix the solution by vortexing or with inversion 3 Using the tube layout report place the Specimen Processing Control s in order in the BD Viper Lysing Rack and lock into place 4 Process the controls according to the Pre warming Procedure and then follow the Test Procedure Preparation of Specimen Processing Controls in LBC Specimen Dilution Tubes ATCC Chlamydia trachomatis 1 Thaw vial of C trachomatis serovar H or LGV II cells received from ATCC 2 Prepare 10 fold serial dilutions to 10 in PBS 3 Add 0 1 mL of 10 dilution of CT to an LBC Specimen Dilution Tube containing 0 5 mL of BD SurePath Preservative Fluid or PreservCyt solution Tightly recap the LBC Specimen Dilution Tube using the blue pierceable cap 4 Invert the LBC Specimen Dilution Tube 3 4 times to ensure that the contents are well mixed 5 Using the tube layout report place the Specimen Processing Control s in order in the BD Viper LBC Specimen Rack and lock into place BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure 6 Specimen Processing Controls are ready to be tested on the BD Viper System in Extracted Mode 7 Change gloves prior to proceeding to avoid contamination ATCC Chlamydia trachomatis and Neisseria gonorrhoeae 1 Thaw vial of C trachomatis serovar H or LGV II cells received from ATCC Prepare 10 fold serial dilutions to 10 in PBS Grow N gonorrhoeae culture
71. rolling contamination particularly to avoid contamination of specimens during manipulation are necessary 34 CHANGE GLOVES if they come in contact with specimen or appear to be wet to avoid contaminating other specimens Change gloves before leaving work area and upon entry into work area 35 In the event of contamination of the work area or equipment with specimens or controls thoroughly clean the contaminated area with 3 w v hydrogen peroxide do not use hydrogen peroxide from a bottle that has remained open for longer than 8 days 1 v v sodium hypochlorite or DNA AWAY and rinse thoroughly with water Allow surface to dry completely before proceeding 36 In case of a spill on the BD Viper Lysing Rack immerse the rack in 1 v v sodium hypochlorite for 1 2 min Do not exceed 2 min Thoroughly rinse the rack with water and allow to air dry 37 Clean the entire work area counter tops and instrument surfaces with 3 w v hydrogen peroxide do not use hydrogen peroxide from a bottle that has remained open for longer than 8 days 1 v v sodium hypochlorite or DNA AWAY on a daily basis Thoroughly rinse with water Allow surfaces to dry completely before proceeding with additional testing 38 Contact BD Technical Service and Support in the event of an unusual situation such as a spill into the BD Viper instrument or DNA contamination that cannot be removed by cleaning 39 Acid and Base spill kits should be on hand in th
72. rols may be tested in accordance with the requirements of appropriate accrediting organizations A positive Specimen Processing Control tests the entire assay system For this purpose known positive specimens can serve as controls by being processed and tested in conjunction with unknown specimens Specimens used as processing controls must be stored processed and tested according to the package insert instructions If a known positive specimen is not available additional options for Specimen Processing Controls are described below Preparation of Specimen Processing Controls in BD ProbeTec Q Swab Diluent ATCC Chlamydia trachomatis 1 Thaw a vial of C trachomatis LGV II or C trachomatis serovar H cells received from ATCC 2 Prepare 10 fold serial dilutions to a 10 dilution at least 4 mL final volume in phosphate buffered saline PBS 3 Place 0 1 mL of the 10 dilution in a BD ProbeTec Q Swab Diluent tube and tightly recap using a black pierceable cap 4 Using the tube layout report place the Specimen Processing Control s in order in the BD Viper Lysing Rack and lock into place 5 Process the controls according to the Pre warming Procedure and then follow the Test Procedure Bio Rad AmpliTrol Chlamydia trachomatis amp Neisseria gonorrhoeae NOTE Refer to manufacturer s processing instructions 1 Add the appropriate volume of Bio Rad AmpliTrol CT GC to a BD ProbeTec Q Swab Diluent tube and tightly recap using a black
73. s 28 BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure 441358 Male Urethral Specimen Collection Kit for the BD ProbeTec Q Amplified DNA Assays 441359 Caps for use on the BD Viper Extracted Mode 4 x 100 441360 Specimen Tubes and Caps for use on the BD Viper Extracted Mode 4 x 100 441361 Swab Diluent for the BD ProbeTec Q Amplified DNA Assays 2 mL x 48 441362 BD Urine Preservative Transport for the Q Amplified DNA Assays 100 units 441444 Liquid Based Cytology Specimen LBC Dilution Tubes for the BD ProbeTec Q Amplified DNA Assays 441443 Liquid Based Cytology Specimen LBC Dilution Tube Caps for the BD ProbeTec Q Amplified DNA Assays 441996 BD Viper LT Pipette Tips 3840 441995 BD Viper LT Solid Waste Liners 80 442950 BD Pre warming Heater 442958 BD Viper LT System SDA Accessory Kit 442839 BD Viper LT System 442842 BD ProbeTec GC Q Assay Gray Amp Reagent Pack 384 tests 442959 BD ProbeTec CT Q Assay Gray Amp Reagent Pack 384 tests 441994 BD Viper SDA Extraction Reagent Trough with Piercing Tool 12 Extraction Reagent Troughs The following strains are available from American Type Culture Collection ATCC 10801 University Boulevard Manassas VA 20110 2209 USA ATCC 19424 Neisseria gonorrhoeae ATCC VR 879 Chlamydia trachomatis serotype H ATCC VR 902B Chlamyd
74. s contact BD Technical Service and Support at 800 638 8663 or www bd com ds 30
75. specimens transferred to the LBC Specimen Dilution Tubes in the BD Viper Lysing Rack or the BD Viper Lysing Heater Specimens transferred to the LBC Specimen Dilution Tubes should be placed in the BD Viper LBC Specimen Rack NOTE If specimens are frozen make sure they are thawed completely at room temperature and mixed by inversion prior to proceeding 1 Make sure the LBC Specimen Dilution Tube has a blue pierceable cap 2 Using the tube layout report place the LBC Specimen Dilution Tube containing the specimen in order in the BD Viper LBC Specimen Rack and lock into place Specimens are ready to be tested on the BD Viper System in Extracted Mode 4 Change gloves prior to proceeding to avoid contamination BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure QUALITY CONTROL Quality control must be performed in accordance with applicable local state and or federal regulations or accreditation requirements and your laboratory s standard Quality Control procedures It is recommended that the user refer to pertinent CLSI guidance and CLIA regulations for appropriate Quality Control practices The Control Set for the BD ProbeTec CT GC Q Amplified DNA Assays is provided separately One Positive and one Negative Control must be included in each assay run and for each new reagent kit lot number Controls must be positioned according to the BD Viper Instrument User s Manual The CT GC Q Positive
76. t not detectable Error BD Viper System with XTR Technology and BD Viper LT System CLSI Laboratory Procedure MONITORING FOR THE PRESENCE OF DNA CONTAMINATION At least monthly the following test procedure should be performed to monitor the work area and equipment surfaces for the presence of DNA contamination Environmental monitoring is essential to detect contamination prior to the development of a problem 1 For each are to be tested use a clean collection swab from the BD ProbeTec Q Collection Kit for Endocervical or Lesion Specimens Dip the swab into the BD ProbeTec Q Swab Diluent Tube and wipe the first area using a broad sweeping motion Fully insert the collection swab into the BD ProbeTec Q Swab Diluent tube Break the shaft of the swab at the score mark Use care to avoid splashing of contents Tightly recap the tube using the black pierceable cap Repeat for each desired area NOap wD After all swabs have been collected and processed according to the Pre warming Procedure and then follow the Test Procedure Recommended areas to test include Instrument deck Pipette Tip Station Covers 2 Tube Processing Station Tube Alignment Block and Fixed Metal Base Deck Waste Area Priming and Warming Heaters Stage Extraction Block Plate Sealing Tool Tip Exchange Stations 2 Instrument Exterior Upper Door Handle Lower Door Handle Waste Liquid Quick Release Valve LCD Monitor Touchscreen Keyboard Scan
77. t contamination prior to the development of a problem 1 For each area to be tested use a clean collection swab from the BD ProbeTec Q Collection Kit for Endocervical or Lesion Specimens 2 Pour off some molecular biology grade nuclease free water into a small clean container Dip the swab into the molecular biology grade nuclease free water and wipe the first area using a broad sweeping motion gt Remove the cap of a tube of Swab Diluent for the BD ProbeTec Q Amplified DNA Assays and insert the swab into the diluent Mix by swirling the swab in the diluent for 5 10s Express the swab along the inside of the tube so that liquid runs back into the bottom of the tube Remove the swab carefully from the swab diluent tube to avoid splashing Discard the swab Tightly recap the diluent tube with the black pierceable cap Repeat for each desired area ONO After all swabs have been collected and expressed process them according to the Pre warming Procedure and then follow the Test Procedure Consult the BD Viper LT System User s Manual for more information on Environmental Monitoring and Cleaning Procedures If a contamination event does not resolve contact BD Technical Service and Support for additional information LIMITATIONS OF THE PROCEDURE 1 This method has been tested only with endocervical vaginal male urethral swab specimens BD SurePath or PreservCyt specimens collected with cytobrush spatula or broom device
78. tal disease SUMMARY AND EXPLANATION The World Health Organization estimates that 92 million new cases of infection due to Chlamydia trachomatis are diagnosed each year In 2008 1 210 523 cases of sexually transmitted Chlamydia trachomatis infection were reported to CDC and case rates were nearly threefold higher among women than men Case rates for chlamydia infection have increased over the past decade in large part due to the expansion of screening programs for asymptomatic individuals and the use of increasingly sensitive diagnostic tests Seventy to 90 of chlamydia infections in women are asymptomatic with the result that long term health problems can develop before a woman even knows she is at risk C trachomatis can cause long term sequelae such as pelvic inflammatory disease and infertility in addition to the birth of underweight babies Fifty percent of C trachomatis infected men are also asymptomatic and in the absence of treatment infection can result in acute urethritis or epididymitis and chronic proctitis Transmission of C trachomatis occurs through sexual contact but can also take place in the birth canal leading to neonatal conjunctivitis and or chlamydial pneumonia Effective antibiotic treatment exists for chlamydial infections and the Advisory Committee on Human Immunodeficiency Virus HIV and Sexually Transmitted Disease STD Prevention encourages active control programs that target treatable STDs as a primary interve
79. to be wet to avoid contaminating other specimens Change gloves before leaving work area and upon entry into work area 38 In the event of contamination of the work area or equipment with specimens or controls thoroughly clean the contaminated area with 3 w v hydrogen peroxide do not use hydrogen peroxide from a bottle that has remained open for longer than 8 days 1 v v sodium hypochlorite or DNA AWAY and rinse thoroughly with water Allow surface to dry completely before proceeding 39 In case of a spill on the BD Viper LT Specimen Rack immerse the rack in 1 v v sodium hypochlorite for 1 2 min Do not exceed 2 min Thoroughly rinse the rack with water and allow to air dry 40 Clean the entire work area including counter tops with 1 v v sodium hypochlorite on a daily basis Thoroughly rinse with water Allow surfaces to dry completely before proceeding with additional testing Clean instrument surfaces with 3 hydrogen peroxide only sodium hypochlorite can damage the electronics located under the deck of the BD Viper LT instrument 41 Contact BD Technical Service and Support in the event of an unusual situation such as a spill into the BD Viper LT instrument or DNA contamination that cannot be removed by cleaning 42 Acid and Base spill kits should be on hand in the event of a spill of extraction reagents SWAB SPECIMEN COLLECTION STORAGE AND TRANSPORT For swab specimens performance data in this package insert have be
80. uted specimens may also be stored at 20 C for up to 90 days SWAB SPECIMEN PROCESSING Processing procedure for the BD ProbeTec Q Collection Kit for Endocervical or Lesion Specimens or the Male Urethral Specimen Collection Kit for the BD ProbeTec Q Amplified DNA Assays NOTE If specimens are refrigerated or frozen make sure they are brought to room temperature and mixed by inversion prior to proceeding 1 Using the tube layout report place the Q Swab Diluent Tube with black pierceable cap in order in the BD Viper Lysing Rack and lock into place 2 Repeat step 1 for additional swab specimens 3 Specimens are ready to be pre warmed 4 Change gloves before proceeding to avoid contamination Processing procedure for the Vaginal Specimen Transport for the BD ProbeTec Q Amplified DNA Assays NOTE Wear clean gloves when handling the vaginal swab specimen If gloves come in contact with specimen immediately change them to prevent contamination of other specimens NOTE If specimens are refrigerated or frozen make sure they are brought to room temperature prior to expression 1 Label a pre filled BD ProbeTec Q Swab Diluent tube for each swab specimen to be processed 2 Remove the cap and insert the swab specimen into the Q Swab Diluent Mix by swirling the swab in the Q Swab Diluent for 5 10s Express the swab along the inside of the tube so that liquid runs back into the bottom of the tube Remove the swab carefully from the

ViperXTR CTQx CLSI 8081408(201012)

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