Influenza A & B Package Insert
Contents
1. If the transport of samples is required the transport medias listed below were tested and are acceptable for use in the Alere i Influenza A amp B system Minimal dilution of the sample is recommended as dilution may result in decreased test sensitivity Elute the swab into 0 5 to 3 0 mL of saline or viral transport media by rotating the swab in the liquid for 10 seconds within 1 hour of sample collection Eluted swab samples can be held at 2 8 C for up to 24 hours prior to testing with Alere i Influenza A amp B If needed transport sample at 2 8 C in a leak proof container Swirl eluted viral transport media samples gently to mix before testing Transport Media Hank s Balanced Salt Solution Stuart s Media M4 Media Tryptose Phosphate Broth M4 RT Media Veal Infusion Broth M5 Media Universal Transport Media M6 Media Starplex Multitrans Phosphate Buffered Saline Vircell Saline It has been determined that Amie s Media Brain Heart Infusion Broth and Dulbecco s Modified Eagles Medium are not suitable for use with this test TEST PROCEDURE Before testing with Alere i Influenza A amp B e Allow all samples to reach room temperature e If stored at 2 8 C allow the blue Sample Receiver to reach room temperature e The orange Test Base can be tested without the need to warm to room temperature e Turn on the Alere i Instrument and log in so that you can see the Home screen ft Home 6 F2. Performance characteristics of the test when other influenza A virus subtypes are emerging as human pathogens have not been established Influenza Strain A California 7 2009 H1N1 A New Caledonia 20 1999 H1N1 A New Jersey 8 76 H1N1 A WSN 33 H1N1 A Port Chalmers 1 73 H3N2 A Hong Kong 8 68 H3N2 A Aichi 2 68 H3N2 A Victoria 3 75 H3N2 A Wisconsin 67 2005 H3N2 15 Alere i Influenza A amp B Package Insert A Perth 16 2009 H3N2 Influenza Strain Bacteria Viruses Yeast A Brisbane 10 2007 H3N2 Acinetobacter Adenovirus type 1 Candida calcoaceticus albicans A Anhui 1 2013 H7N9 B Lee 40 Bacteroides fragilis Adenovirus type 7 B Russia 69 B Bangladesh 3333 2007 B Victoria 504 2000 B Wisconsin 01 2010 B Maryland 1 59 Analytical Specificity Cross Reactivity To determine the analytical specificity of Alere i Influenza A amp B 53 commensal and pathogenic microorganisms 37 bacteria 15 viruses and 1 yeast that may be present in the nasal cavity or nasopharynx were tested All of the following microorganisms were negative when tested at concentrations ranging from 108 to 10 cells mL CFU mL or IFU mL bacteria 104 to 108 TCID mL or CEID mL viruses and 108 cells mL yeast Bordetella pertussis Human Coronavirus 0C43 Chlamydia Human Coronavirus pneumoniae 229E Corynebacterium En
3. due to Flu B cannot be ruled out If infection with Flu B is suspected repeat testing of the sample using new test components If repeated Flu B Invalid results are obtained results should be confirmed by another method prior to reporting the results Test Results 1 Jan 2014 Patient ID 10AX425 User ID Alereuser1 Flu A Invalid Flu B Negative New Test h 11 22am Procedural Control Valid Negative for Flu B viral RNA Infection due to Flu A cannot be ruled out If infection with Flu A is suspected repeat testing of the sample using new test components If repeated Flu A Invalid results are obtained results should be confirmed by another method prior to reporting the results Test Results 7 Feb 2013 Patient ID 10AX425 Flu A Invalid Flu B Invalid New Test ft Invalid Repeat the test using new test components If repeated Invalid results are obtained repeat test with a new patient sample and new test components LIMITATIONS Alere i Influenza A amp B performance depends on viral RNA load and may not correlate with cell culture performed on the same specimen Viral nucleic acid may persist in vivo independent of virus viability Detection of analyte target does not imply the corresponding virus es are infectious or are the causative agents for clinical symptoms Performance of Alere i Influenza A amp B has not been established for monitoring a
4. robust At a very low frequency clinical samples can contain inhibitors that may generate invalid results Procedural Control Valid displayed on the instrument screen indicates that the assay reagents maintained their functional integrity and the sample did not significantly inhibit assay performance 4 Alere i Influenza A amp B Package Insert External Positive and Negative Controls Good laboratory practice suggests the use of positive and negative controls to ensure that test reagents are working and that the test is correctly performed Alere i Influenza A amp B kits contain Positive and Negative Control Swabs These swabs will monitor the entire assay Test these swabs once with each new shipment received and once for each untrained operator Further controls may be tested in order to conform with local state and or federal regulations accrediting groups or your lab s standard Quality Control procedures CONTROL SWAB PROCEDURE External Positive and Negative Control swabs are provided and should be tested following the Run QC Test instructions on the Alere i Instrument Refer to Test Procedure or Instrument User Manual for further details Note The Alere i Instrument reports QC results as Pass or Fail Flu A B Positve QC pass indicates a positive result for both influenza A and influenza B If the correct control results are not obtained do not perform patient tests or report patient results Contact Techn
5. symptom information was self reported and 92 6 99 1 96 7 100 was not colleted using clinical study controls NASAL SWAB SAMPLES IN VIRAL TRANSPORT MEDIA Alere i Influenza A amp B Performance vs Culture All Age Groups Combined Influenza Type A Culture Culture Alere i 86 37 123 Alere i 3 316 319 89 353 442 Sensitivity 86 89 96 6 95 Cl 90 6 98 8 Specificity 316 353 89 5 95 Cl 85 9 92 3 Influenza Type B Culture Culture Alere i 53 13 66 Alere i 10 365 375 63 378 441 Sensitivity 53 63 84 1 95 Cl 73 2 91 1 Specificity 365 378 96 6 95 Cl 94 2 98 0 Less than one percent 0 5 2 444 of the total number of specimens tested generated invalid results for Flu A 95 Cl 0 1 1 6 Less than one percent 0 7 3 444 of the total number of specimens tested generated invalid results for Flu B 95 Cl 0 2 2 0 There were a large number of samples with discrepant Alere i Influenza A amp B and culture results In most cases Alere i Influenza A amp B was positive and culture was negative indicating that Alere i Influenza A amp B is more sensitive than viral culture for the detection of influenza A and or B All discrepant samples were tested on an FDA cleared RT PCR assay at a central testing laboratory to confirm influenza status Performance of Alere i Influenza A am
6. 1 4an 2014 Patient ID 10AX425 User ID Alereusert Flu A Positive Flu B Invalid New Test 11 22am Procedural Control Valid Positive for Flu A viral RNA This result does not rule out co infections with other pathogens or identify any specific influenza A virus subtype Test Results 1 Jan 2014 Flu A Negative Flu B Positive New Test ft 11 22am Procedural Control Valid Positive for Flu B viral RNA This result does not rule out co infections with other pathogens or identify any specific influenza B virus subtype Test Results 1 Jan 2014 11 22am Patient ID 1 Procedural User ID Alere Control Valid Flu A Positive Flu B Positive New Test Positive for Flu A and Flu B viral RNA Co infection with influenza A and B is rare This result does not rule out co infections with other pathogens or identify any specific influenza A or influenza B virus subtype Test Results 1 Jan 2014 11 22am Patient ID 10AX425 Procedural User ID Alereusert Control Valid Flu A Negative Flu B Negative New Test hA Negative for Flu A and Flu B viral RNA 7 Alere i Influenza A amp B Package Insert Instrument Display Suggested Report Test Results 1 Jan 2014 Patient ID 10AX425 User ID Alereuser1 Flu A Negative Flu B Invalid New Test h 11 22am Procedural Control Valid Negative for Flu A viral RNA Infection
7. Alere i Influenza A amp B Package Insert Alere i Influenza A amp B Package Insert INTENDED USE Alere i Influenza A amp B is a rapid instrument based molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of influenza A and B viral nucleic acid in nasal swab and viral transport media specimens It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections SUMMARY AND EXPLANATION OF THE TEST Influenza is a highly contagious acute viral infection of the respiratory tract It is a communicable disease that is easily transmitted through the coughing and sneezing of aerosolized droplets containing live virus Influenza outbreaks occur each year during the fall and winter months Type A viruses are typically more prevalent than type B viruses and are associated with most serious influenza epidemics while Type B infections are usually milder Rapid diagnostics with increased sensitivity are essential for the reliable detection of influenza A and B allowing immediate effective treatment decisions Rapid diagnosis of influenza can lead to reduced hospital stays reduced secondary complications and reduced cost of hospital care and allow effective implementation of infection control measures Alere i Influenza A amp B is a rapid instrument based isothermal test for the qualitative detection and differ
8. a the Transfer Cartridge to the Test Base initiating target amplification Heating mixing and detection is provided by the instrument with results automatically reported REAGENTS AND MATERIALS Materials Provided Test Bases Orange plastic components containing two reaction tubes of lyophilized reagents for the targeted amplification of Influenza A and B viral RNA Sample Receivers Blue plastic components containing 2 5 mL of elution buffer Transfer Cartridges White plastic components used to transfer 2 x 100 uL of sample extract from the Sample Receiver to the Test Base Sterile swabs for use with the Alere i Influenza A amp B Test The positive control swab is coated with inactivated influenza A and B viruses Nasal Swabs Positive Control Swab Negative Control Swab The negative control swab is coated with inactivated Group C Streptococcus Package Insert Quick Reference Guide Materials Required but not Provided Alere i Instrument 2 Alere i Influenza A amp B Package Insert PRECAUTIONS wo A D OVP For in vitro diagnostic use To be used in conjunction with the Alere i Instrument Leave test pieces sealed in their foil pouches until just before use Do not tamper with test pieces prior to use Do not use kit past its expiration date Do not mix components from different kit lots Solutions used to make the control swabs are inactivated using standard methods H
9. an in vitro diagnostics IN425001 Rev 2 2014 11
10. ators 6 operators 14 Alere i Influenza A amp B Package Insert Analytical Sensitivity Limit of Detection Alere i Influenza A amp B limit of detection LOD or Cos defined as the concentration of influenza virus that produces positive Alere i Influenza A amp B results approximately 95 of the time was identified by evaluating different concentrations of 2 strains of influenza A and 2 strains of influenza B virus in Alere i Influenza A amp B The concentrations identified as the LOD or Cogs levels for each strain tested are listed below Influenza Strain Concentration Detected TCID mL per Total Detected Tests A Solomon 4 75 x 10 19 20 95 Islands 3 2006 H1N1 A Puerto Rico 8 34 5 48 x 103 19 20 95 H1N1 B Malaysia 7 5 x 10 19 20 95 2506 2004 B Brisbane 5 00 x 10 19 20 95 6 2008 A Brisbane 59 2007 H1N1 Analytical Reactivity The influenza A and B strains listed tested positive with Alere i Influenza A amp B at concentrations ranging from 10 to 10 TCIDso mL 10 ElDso mL or 10 CEIDso mL Although the specific influenza strains causing infection in humans can vary year to year all contain the conserved nucleic acid sequence targeted by Alere i Influenza A amp B Performance characteristics of Alere i Influenza A amp B for detecting influenza A virus from human specimens were established when H1 and H3 subtypes were prevalent
11. e sensitive than viral culture for the detection of influenza A and or B All discrepant samples were tested on an FDA cleared RT PCR assay at a central testing laboratory to confirm influenza status Performance of Alere i Influenza A amp B for the detection of Flu A and Flu B when the results of PCR are incorporated for all age groups combined is presented in the table below Alere i Influenza A amp B Performance vs Culture All Age Groups Combined Discrepant Results Resolved by RT PCR Influenza Type A Culture or Culture or PCR PCR Alere i 150 8 158 Alere i 1 412 413 151 420 571 Culture Culture Alere i 92 66 158 Alere i 2 411 413 94 477 571 Sensitivity 92 94 97 9 95 Cl 92 6 99 4 Specificity 411 477 86 2 95 Cl 82 8 89 0 Influenza Type B Culture Culture Alere i 74 17 91 Alere i 6 472 478 80 489 569 Sensitivity 150 151 99 3 95 Cl 96 3 99 9 Specificity 412 420 98 1 95 Cl 96 3 99 0 Sensitivity 74 80 92 5 95 Cl 84 6 96 5 Specificity 472 489 96 5 95 Cl 94 5 97 8 Two percent 2 14 585 of the total number of specimens tested generated invalid results for Flu A 95 Cl 1 4 4 0 Three percent 3 16 585 of the total number of specimens tested generated invalid results for Flu B 95 Cl 1 7 4 4 There were a large nu
12. eb 2014 12 00pm Run Run QC Test Test Review Memory Preferences Setup Log Out To Perform Test 1 Select Run Test 2 Scan or input Patient ID 3 Follow the step by step instructions shown on the instrument screen Refer to the Running a Test in the Alere i Instrument User Manual for further details For QC testing select Run QC Test on the Home screen and follow the displayed instructions Refer to Running a QC Test in the Alere i Instrument User Manual for further details 6 Alere i Influenza A amp B Package Insert RESULT INTERPRETATION When the test is complete the results are clearly displayed on the instrument screen An individual result for both influenza A and influenza B will be provided Instrument Display Suggested Report Instrument Display Suggested Report Test Results Patient ID 10AX425 User ID Alereuser1 Flu A Positive Flu B Negative New Test 11 22am Procedural Control Valid Positive for Flu A viral RNA This result does not rule out co infections with other pathogens or identify any specific influenza A virus subtype Test Results 1 4an 2014 11 22am Patient ID 10AX425 Procedural User ID Alereuser1 Control Valid Flu A Invalid Flu B Positive New Test Positive for Flu B viral RNA This result does not rule out co infections with other pathogens or identify any specific influenza B virus subtype Test Results
13. entiation of influenza A and influenza B from nasal swab and viral transport media specimens The Alere i Instrument has a small footprint and easy to use graphical user interface for convenience within a busy hospital or point of care environment The Alere i Influenza A amp B kit contains all components required to carry out an assay for influenza A and B on the Alere i Instrument 1 Alere i Influenza A amp B Package Insert PRINCIPLES OF THE PROCEDURE Alere i Influenza A amp B utilizes isothermal nucleic acid amplification technology for the differential and qualitative detection of influenza A and influenza B viral nucleic acids It is comprised of a Sample Receiver containing elution buffer a Test Base comprising two sealed reaction tubes each containing a lyophilized pellet a Transfer Cartridge for transfer of the eluted sample to the Test Base and the Alere i Instrument The reaction tubes in the Test Base contain the reagents required for amplification of the target nucleic acid and an internal control Alere i Influenza A amp B utilizes a pair of templates similar to primers for the specific amplification of RNA from influenza A and B and a fluorescently labelled molecular beacon designed to specifically identify the amplified RNA targets To perform the assay the Sample Receiver and Test Base are inserted into the Alere i Instrument The sample is added to the Sample Receiver and transferred vi
14. ere evaluated with Alere i Influenza A amp B at the concentrations listed below and were found not to affect test performance Substance Concentration Mucin 20 ug mL Whole Blood 50 ul mL Sinus Buster Nasal Spray 200 ul mL NeoSynephrine Cold amp Sinus Extra 200 ul mL Strength Spray Zicam Extreme Congestion Relief 200 ul mL 4 acetamidophenol 200 ug mL Acetylsalicylic acid 650 ug mL Albuterol 400 ng mL 17 Alere i Influenza A amp B Package Insert Substance Concentration Chlorpheniramine 145 ng mL Dexamethasone 0 80 mg mL Dextromethorphan 1 ug mL Diphenhydramine 5 ug mL Doxylamine Succinate 236 ng mL Ephedrine 273 ng mL Flunisolide 6 8 ng mL Guaiacol glycerol ether 3 5 ng mL Mupirocin 12 mg mL Oxymetazoline 0 6 mg mL Phenylephrine 12 mg mL Rebetol 4 5 ug mL Relenza 282 ng mL Rimatadine 282 ng mL Tamiflu 1 1 ug mL Tobramycin 2 43 mg mL Triamcinolone 40 ug mL SYMBOLS Fragile handle with care Test Base Transfer Cartridge Sample Receiver 18 Alere i Influenza A amp B Package Insert ORDERING AND CONTACT INFORMATION Reorder numbers 425 000 Alere i Influenza A amp B 24 Test Kit NAT 000 Alere i Instrument 425 080 Alere i Influenza A amp B Control Swab Kit OUS 1 321 441 7200 Technical Support Advice Line Further information can be obtained from your distributor or by c
15. ical Support during normal business hours before testing patient specimens SPECIMEN COLLECTION AND HANDLING Use freshly collected specimens for optimal test performance Inadequate specimen collection or improper sample handling storage transport may yield erroneous results Nasal Swab For optimal performance use the swabs provided in the test kit Alternatively rayon foam flocked or polyester nasal swabs can be used to collect nasal swab samples Calcium alginate and Puritan Purflock Ultra flocked swabs are not suitable for use in this assay Other flocked swabs have been validated for use To collect a nasal swab sample carefully insert the swab into the nostril exhibiting the most visible drainage or the nostril that is most congested if drainage is not visible Using gentle rotation push the swab until resistance is met at the level of the turbinates less than one inch into the nostril Rotate the swab several times against the nasal wall then slowly remove from the nostril Swab specimens should be tested as soon as possible after collection If immediate testing is not possible the nasal swab can be held in its original package at room temperature for up to two 2 hours prior to testing If the swab will be held longer than two 2 hours it must be refrigerated at 2 8 C and tested within 24 hours from the time of sample collection 5 Alere i Influenza A amp B Package Insert SPECIMEN TRANSPORT AND STORAGE
16. llection 93 96 96 9 36 39 92 3 95 Cl 91 2 98 9 79 7 97 4 2 4 Days Type A Type B Between Onset amp 5 5 100 5 5 100 Sample Collection 56 6 100 56 6 100 95 Cl gt 4 Days Type A Type B Between Onset amp Ak sE 1 1 100 1 1 100 Sample Collection 95 Cl 20 7 100 20 7 100 Note The patients symptom information was self reported and was not collected using clinical study controls ANALYTICAL STUDIES Reproducibility A reproducibility study of Alere i Influenza A amp B was conducted by operators from 3 sites using panels of blind coded specimens containing negative high negative below the limit of detection low positive at the limit of detection and moderate positive above the limit of detection influenza A and B viral samples Participants tested each sample multiple times on 5 different days The detection rates for the influenza A moderate positive low positive and high negative samples were 100 90 90 100 90 90 and 30 27 90 respectfully The detection rates for the influenza B moderate positive low positive and high negative samples were 100 90 90 92 83 90 and 10 9 90 respectfully All of the negative samples 90 generated negative test results There were no significant differences within run replicates tested by one operator between run 5 different days between sites 3 sites or between oper
17. mber of samples with discrepant Alere i Influenza A amp B and culture results In most cases Alere i Influenza A amp B was positive and culture was negative indicating Influenza Type B Culture or Culture or PCR PCR Alere i 89 2 91 Alere i 2 476 478 91 478 569 Sensitivity 89 91 97 8 95 Cl 92 3 99 4 Specificity 476 478 99 6 95 Cl 98 5 99 9 10 Alere i Influenza A amp B Package Insert Alere i Influenza A amp B Performance vs Culture By Age Group Discrepant Results Resolved by RT PCR si 98 8 100 95 CI 85 86 38 38 112 113 99 1 93 7 99 8 90 8 100 95 2 99 8 98 8 100 Spec uc 243 246 292 292 96 5 99 6 98 7 100 aoei 77 2 100 85 5 98 8 Alere i Influenza A amp B Sensitivity vs Culture By Time Between Onset of Symptoms and Sample Collection Discrepant Results Resolved by RT PCR 44 46 95 7 19 19 100 83 2 100 ean 100 100 dii 18 18 13 13 82 4 100 77 2 100 dei 96 6 96 9 du 57 59 62 64 88 5 99 1 89 3 99 1 11 Alere i Influenza A amp B Package Insert ou 100 95 0 95 CI 47 47 38 40 1 1 100 1 1 100 92 4 100 83 5 98 6 20 7 100 20 7 100 Spee 97 4 100 95 Cl 112 115 122 122 Note The patients
18. ments and surrounding surfaces according to instructions provided in the cleaning section of the instrument User Manual Refer to Section 1 6 Maintenance amp Cleaning for further information STORAGE AND STABILITY For convenience the entire kit may be refrigerated at 2 8 C The orange Test Base kit must be stored at 2 8 C The remainder of the kit can be stored at room temperature 15 30 C if preferred The blue Sample Receiver must be allowed to reach room temperature prior to use if stored at 2 8 C Do not freeze The orange Test Base stored at 2 8 C can be tested without the need to warm to room temperature Alere i Influenza A amp B kits are stable until the expiration dates marked on their outer packaging and containers QUALITY CONTROL Alere i Influenza A amp B has built in procedural controls The result of the Procedural Control is displayed on the screen and is automatically stored in the instrument with each test result This can be reviewed later by selecting Review Memory on the instrument Procedural Controls Alere i Influenza A amp B contains an internal control that has been designed to control for sample inhibition amplification and assay reagent function In positive samples where target amplification is strong the internal control is ignored and the target amplification serves as the control to confirm that the clinical sample was not inhibitory and that assay reagent performance was
19. ntiviral treatment of influenza Visibly bloody samples must not be used with Alere i Influenza A amp B Individuals who have received nasally administered influenza vaccine may test positive in commercially available influenza rapid diagnostic tests for up to three days after vaccination If differentiation of specific influenza subtypes and strains is needed additional testing in consultation with state or local public health departments is required 8 Alere i Influenza A amp B Package Insert EXPECTED VALUES The prevalence of influenza varies from year to year with outbreaks typically occurring during the fall and winter months The rate of positivity found in influenza testing is dependent on many factors including the method of specimen collection the test method used geographic location and the disease prevalence in specific localities Type A viruses are typically associated with most serious influenza epidemics while Type B are typically milder In multi center clinical studies conducted in the U S during the 2012 2013 respiratory season the average prevalence of influenza A as determined by viral cell culture was 16 The average prevalence of influenza B was 14 PERFORMANCE CHARACTERISTICS Clinical Study The clinical performance of Alere i Influenza A amp B was established in a multi center prospective clinical study conducted at 8 US trial sites during the 2012 2013 respiratory seasons A
20. ontacting Technical Support on Africa Russia CIS 972 8 9429 683 ARCISproductsupport alere com Asia Pacific 61 7 3363 7711 APproductsupport alere com Canada 1 800 818 8335 CANproductsupport alere com Europe amp Middle East 44 161 483 9032 EMEproductsupport alere com Latin America 57 2 6618797 LAproductsupport alere com REFERENCES 1 Williams KM Jackson MA Hamilton M Rapid Diagnostic Testing for URIs in Children Impact on Physician Decision Making and Cost Infect Med 19 3 109 111 2002 Bonner A B et al Impact of the Rapid Diagnosis of Influenza on Physician Decision Making and Patient Management in the Pediatric Emergency Department Results of a Randomized Prospective Controlled Trial Pediatrics 2003 Vol 112 No 2 19 Alere i Influenza A amp B Package Insert Alere Scarborough Inc 10 Southgate Road Scarborough Maine 04074 USA www alere com EMERGO EUROPE Molenstraat 15 C 2513 BH The Hague The Netherlands Alere i Influenza A amp B Product Insert 2014 Alere All rights reserved The Alere Logo and Alere are trademarks of the Alere group of companies Software 2014 Axxin used under license All trademarks referenced are trademarks of their respective owners This product is licensed and sold under agreement with Biosearch Technologies Inc This product is sold under license from PHRI Properties and may be used under PHRI Properties patent rights only for hum
21. owever patient samples controls and test pieces should be handled as though they could transmit disease Observe established precautions against microbial hazards during use and disposal If any assay components are dropped cracked found to be damaged or opened when received DO NOT USE and discard Do not use scissors or sharp objects to open foil pouches as damage to test pieces can occur Do not open the Sample Receiver before placing in the instrument It will prohibit the Elution Buffer from reaching temperature and may impact test performance 10 If the Sample Receiver is spilled while opening clean the instrument per instructions provided in the instrument User Manual and cancel test Repeat test with a new Sample Receiver 11 All test pieces must be removed from the instrument according to removal instructions displayed on the instrument and disposed of according to country and local requirements Pieces must not be separated once they are assembled 12 If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing Viral culture should not be attempted in these cases unless a BSL 3 facility is available to receive and culture specimens 13 All tes
22. p B for the detection of Flu A and Flu B when the results of PCR are incorporated for all age groups combined is presented in the table below 12 Alere i Influenza A amp B Package Insert Alere i Influenza A amp B Performance vs Culture Alere i Influenza A amp B Performance vs Culture All Age Groups Combined By Age Group Discrepant Results Resolved by RT PCR Discrepant Results Resolved by RT PCR Influenza Type A n 97 5 90 6 05 ch 79 81 29 32 91 4 99 3 75 8 96 8 99 1 99 6 sd ee 219 221 268 269 Sensitivity 119 122 97 5 95 Cl 93 0 99 2 95 Cl 96 8 99 8 97 9 99 9 Specificity 316 320 98 8 95 Cl 96 8 99 5 Influenza Type B a 97 4 89 3 esso 38 39 25 28 86 8 99 5 72 8 96 3 ron 97 6 96 8 65 ci 81 83 91 94 91 6 99 3 91 0 98 9 Sensitivity 57 63 90 5 95 Cl 80 7 95 6 Specificity 369 378 97 6 95 Cl 95 5 98 7 She 100 100 95 CI 2 2 3 3 34 2 100 43 9 100 Spec 100 66 7 95 Cl 16 16 10 15 80 6 100 41 7 84 8 18 Alere i Influenza A amp B Package Insert Alere i Influenza A amp B Sensitivity vs Culture By Time Between Onset of Symptoms and Sample Collection Discrepant Results Resolved by RT PCR Influenza Type lt 2 Days Type A Type B Between Onset amp Sample Co
23. t pieces are single use items Do not use with multiple specimens 14 Performance characteristics for influenza A were established when influenza A H3 and A H1 were the predominant influenza A viruses in circulation When other influenza A viruses are emerging performance characteristics may vary 15 The regions selected for amplification are conserved among all known Influenza A and Influenza B subtypes and strains where sequence data is available from public databases Laboratory testing has shown that Alere i Influenza A amp B can readily amplify and detect H1N1 H3N2 variant and H7N9 influenza subtypes but the utility of the assay for detection of these subtypes in a clinical setting has not been established due to the lack of sufficient numbers of samples 3 Alere i Influenza A amp B Package Insert 16 Once reacted the Test Base contains large amounts of amplified target Amplicon Do not disassemble the Test Base and Transfer Cartridge In the case of a positive sample this could lead to amplicon leakage and potential Alere i Influenza A amp B false positive test results 17 At a very low frequency clinical samples can contain inhibitors that may generate invalid results 18 Due to the high sensitivity of the assays run on the instrument contamination of the work area with previous positive samples may cause false positive results Handle samples according to standard laboratory practices Clean instru
24. terovirus diphtheriae Coxsackievirus B4 Enterococcus Human faecalis Cytomegalovirus CMV Herpes V Escherichia coli Epstein Barr Virus Gardnerella vaginalis Human metapneumovirus Haemophilus influenzae Measles Edmonston Klebsiella pneumoniae Mumps Enders Lactobacillus casei Parainfluenza 1 Lactobacillus plantarum Parainfluenza 2 Legionella pneumophila Parainfluenza 3 Listeria monocytogenes Respiratory Syncytial Virus type B 16 Alere i Influenza A amp B Package Insert Bacteria Viruses Yeast Bacteria Viruses Yeast Moraxella Branhamella catarrhalis Rhinovirus type 1A Mycobacterium avium Mycobacterium intracellulare Mycobacterium tuberculosis Mycoplasma pneumoniae Neisseria gonorrhoeae Neisseria meningitidis Neisseria sicca Neisseria subflava Proteus vulgaris Pseudomonas aeruginosa Serratia marcescens Staphylococcus aureus Staphylococcus epidermidis Streptococcus Group A Streptococcus Group B Streptococcus Group C Streptococcus Group F Streptococcus Group G Streptococcus mutans Streptococcus pneumoniae Streptococcus salivarius Streptococcus sanguinis Interfering Substances The following substances naturally present in respiratory specimens or that may be artificially introduced into the nasal cavity or nasopharynx w
25. total of 571 prospective nasal swab specimens collected from patients of all ages presenting with influenza like symptoms were evaluated with Alere i Influenza A amp B and compared to viral culture Fifty eight percent 68 of the population tested was lt 5 years of age 28 was 6 21 years of age and 13 was gt 21 years A H3 and A H1 were the predominant influenza A subtypes observed during the times the specimens were collected In this study two 2 nasal swabs were collected from each of a total of 571 patients One nasal swab from each patient was tested with Alere i Influenza A amp B The other nasal swab was placed in 3 mL of VTM eluted and used for viral culture At four 4 designated sites the eluted sample was also tested with Alere i Influenza A amp B Alere i Influenza A amp B performance including 95 confidence intervals versus viral culture presented by sample type and stratified by age group is provided below Alere i Influenza A amp B sensitivity versus positive culture results for influenza A or influenza B is also presented by the duration of time that passed between the onset of symptoms and when the sample was collected 9 Alere i Influenza A amp B Package Insert NASAL SWAB DIRECT WITHOUT DILUTION IN VIRAL TRANSPORT MEDIA Alere i Influenza A amp B Performance vs Culture All Age Groups Combined Influenza Type A that Alere i Influenza A amp B is mor
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