. MAXTM
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1. SBD MAX ExK DNA 2 BD MAX ExK DNA 2 442819 Cerebral Spinal Fluid or Dry Swabs ie Be For use with the BD MAX System INTENDED USE The BD MAX ExK DNA 2 is intended to extract DNA from cerebral spinal fluid CSF or dry swab specimens The DNA Extraction Tube contains a Sample Processing Control sequence from Drosophila melanogaster GenBank AC246436 nucleotides 35779 to 35978 cloned in a pUC119 derivative GenBank U07650 1 The BD MAX ExK DNA 2 has not been validated for use with any specific test method PRINCIPLES OF THE PROCEDURE The specimen is mixed with the BD MAX Sample Buffer Tube and processed using the BD MAX System The BD MAX System automates sample lysis DNA extraction and concentration reagent rehydration nucleic acid amplification and detection of the target nucleic acid sequence using real time polymerase chain reaction PCR The BD MAX System contains a combination of lytic and extraction reagents designed to perform cell lysis and DNA extraction Following cell lysis the released DNA is captured by magnetic affinity beads The beads with the bound DNA are washed and then the DNA is eluted using 12 5 uL of Elution Buffer The solution may be prepared for PCR using Neutralization Buffer from the Unitized Reagent Strip The eluted DNA may be used for applications on the BD MAX System or another PCR Amplification Detection System REAGENTS COMPONENT NAME QUANTITY BD MAX E2. ation Extraction Preparation Note The following extraction preparation procedures are provided as guidance Some specimens may require pre processing Application specific extraction preparation procedures should be developed and validated by the user 1 CSF Pipette 200 uL of specimen into a BD MAX DNA Sample Buffer Tube SB 2 and close the tube with a septum cap Ensure complete mixing by vortexing the sample 2 Dry Swab Insert swab into a BD MAX DNA Sample Buffer Tube SB 2 and swirl at least three times Lift the swab out of the liquid and press against the side of the Sample Buffer Tube to expel residual specimen Completely remove the swab from the tube discard appropriately and close the tube with a septum cap Ensure complete mixing by vortexing the sample 3 Proceed to BD MAX System Operation BD MAX System Operation Note Refer to the BD MAX System User s Manual for detailed instructions Operation section 1 Power on the BD MAX System if not already done and log in by entering lt user name gt and lt password gt 2 Gloves must be changed before manipulating reagents and cartridges 3 Remove the required number of Unitized Reagent Strips from the BD MAX ExK DNA 2 kit Gently tap each strip onto a hard surface to ensure that all the liquids are at the bottom of the tubes 4 Remove the required number of Extraction Tube s and Master Mix Tube s if applicable from their protective pouches Remove exc
3. e seals of the BD MAX PCR Cartridges are designed to prevent contamination e The laboratory should routinely perform environmental monitoring to minimize the risk of cross contamination Always handle specimens as if they are infectious and in accordance with safe laboratory procedures such as those described in CLS Document M29 and in Biosafety in Microbiological and Biomedical Laboratories Wear protective clothing and disposable gloves while handling all reagents Wash hands thoroughly after performing the test Do not pipette by mouth Do not smoke drink chew or eat in areas where specimens or kit reagents are being handled Dispose of unused reagents and waste in accordance with local state provincial and or federal regulations Consult the BD MAX System User s Manual for additional warnings precautions and procedures STORAGE AND STABILITY e BD MAX ExK DNA 2 components are stable at 2 25 C through the stated expiration date Do not use if expired e The BD MAX DNA Extraction Tubes A8 are provided in sealed pouches To protect product from humidity immediately re seal after opening The Extraction Tubes are stable for up to 7 days at 2 25 C after initial opening and re sealing of the pouch INSTRUCTIONS FOR USE Specimen Collection 1 Collect specimen and label appropriately 2 Collected specimens should be maintained per the conditions validated by the user 3 Proceed to Extraction Prepar
4. eagent Strips assembled in step 5 Note Place the Sample Buffer Tubes in the sample rack s with the 1D barcode labels facing outward this makes scanning Sample Buffer Tubes easier during sample login If the BD MAX System is also being used for DNA amplification place the required number of BD MAX PCR Cartridge s into the BD MAX System see Figure 2 e Each cartridge accommodates 2 runs of up to 12 samples for a total of 24 samples e The BD MAX System will automatically select the position and row on the PCR Cartridge for each run e PCR Cartridges are used on a per run AND rack basis 2 runs per cartridge and 1 cartridge per rack Figure 2 BD MAX System Pipette Tips Buffers Extraction Tube Master Mix Tube Sample Rack A Sample Rack B 13 Load rack s onto the BD MAX System Figure 2 14 Close the BD MAX System lid and click lt Start gt to begin processing LIMITATIONS OF THE PROCEDURE 1 The BD MAX ExK DNA 2 can only be used on the BD MAX System by trained personnel 2 Use of the BD MAX ExK DNA 2 for clinical specimen types other than those specified have not been validated 3 The selected application of this product must be validated by the user Validations should be performed in accordance with country federal provincial state local and or accrediting organization guidelines regulations and standards REFERENCES 1 Clinical and Laboratory Standards Institute Protec
5. ess air and close pouches with the zip seal 5 For each specimen to be tested place one 1 Unitized Reagent Strip on the BD MAX System Rack starting with Position 1 of Rack A Assemble the strip as follows N 10 11 Figure 1 BD MAX Unitized Reagent Strip Note A tube is fully seated in the strip when a click is heard Refer to Figure 1 for reagent placement in the Unitized Reagent Strip a Extraction only e Position 1 Snap the DNA Extraction Tube into position 1 e Position 2 Leave position 2 empty e Position 3 Snap a BD MAX Conical Tube into position 3 b Type 1 BD MMK or MMK SPC and Dried Primers and Probes e Position 1 Snap the DNA Extraction Tube into Position 1 e Position 2 Snap the BD MAX DNA MMK SPC or BD MAX DNA MMK Master Mix Tube into position 2 e Position 3 Snap a BD MAX Conical Tube containing dried down primer and probe mixture at a final concentration of 2X into position 3 c Type 2 BD MMK or MMK SPC and Liquid Primers and Probes e Position 1 Snap the DNA Extraction Tube into Position 1 e Position 2 Snap the BD MAX DNA MMK SPC or BD MAX DNA MMK Master Mix Tube into position 2 follow the instructions for use accompanying that product e Position 3 Snap a BD MAX Conical Tube into position 3 Pipette 12 5 uL of user supplied primer and probe mixture at a final concentration of 2X into the bottom of the Conical Tube
6. in position 3 d Type 3 Liquid MM with Primers and Probes e Position 1 Snap the DNA Extraction Tube into Position 1 e Position 2 Leave position 2 empty e Position 3 Snap a BD MAX Conical Tube into position 3 Pipette 12 5 uL of the user supplied master mix primer and probe mixture at a final concentration of 2X into the BD MAX Conical Tube in position 3 e Type 4 Lyophilized MM with Primers and Probes e Position 1 Snap the DNA Extraction Tube into Position 1 e Position 2 Snap a BD MAX Conical Tube containg user supplied lyophilized master mix in position 2 e Position 3 Snap a BD MAX Conical Tube into position 3 Pipette 12 5 uL of user supplied rehydration buffer into the BD MAX Conical Tube in position 3 Click on the Run icon and enter the kit lot number for the BD MAX ExK DNA 2 for lot traceability by either scanning the barcode with the scanner or by manual entry Note Repeat step 6 each time a new kit lot is used Navigate to the Worklist Using the pull down menu select lt ExK DNA 2 gt Enter the Sample Buffer Tube ID Patient ID and Accession Number if applicable into the Worklist either by scanning the barcode with the scanner or by manual entry Select the appropriate kit lot number found on the outer box from the pull down menu Repeat Steps 7 9 for all remaining Sample Buffer Tubes Place the Sample Buffer Tubes in the BD MAX System Rack s corresponding to the Unitized R
7. st heat and humidity Prolonged exposure to humidity may affect product performance Do not use reagents if the foil has been broken or damaged Do not mix reagents from different pouches and or kits and or lots Do not interchange or reuse caps as contamination may occur and compromise test results Check Unitized Reagent Strips for proper liquid fills ensure that the liquids are at the bottom of the tubes refer to Figure 1 Check Unitized Reagent Strips to ensure that all pipette tips are present refer to Figure 1 Proceed with caution when using chemical solutions as Extraction Tube barcode readability may be altered Good laboratory technique is essential for the proper use of this product Extreme care should be taken to preserve the purity of all materials and reagents e In cases where other PCR tests are conducted in the same general area of the laboratory care must be taken to ensure that the BD MAX DNA 2 any additional reagents required for testing and the BD MAX System are not contaminated Avoid microbial and ribonuclease RNase deoxyribonuclease DNase contamination of reagents at all times The use of sterile RNase DNase free disposable aerosol resistant or positive displacement pipette tips is recommended Use a new tip for each specimen Gloves must be changed before manipulating reagents and cartridges e To avoid contamination of the environment by amplicons do not break apart the BD MAX PCR Cartridge after use Th
8. tion of laboratory workers from occupationally acquired infections Approved Guideline Document M29 Refer to the latest edition 2 Centers for Disease Control and Prevention and National Institutes of Health Biosafety in microbiological and biomedical laboratories Chosewood L C and Wilson D E eds 2009 HHS Publication No CDC 21 1112 3 BD MAX System Users Manual US Open System version 8089571 or International version 8089570 refer to the latest revision BD Diagnostics Sparks MD USA si Temperature limitations Perforation ad Manufacturer E Batch code Lot Catalog number z Use by YYYY MM DD YYYY MM MM end of month IVD In vitro Diagnostic Use Medical Use W Contains sufficient for lt n gt tests aa Keep dry Ba Consult Instructions for Use This product is sold under license and purchase of this product does not include rights to use for certain blood and tissue screening applications nor for certain industrial applications BD Technical Information In the United States contact BD Technical Service and Support at 1 800 638 8663 or www bd com ds mi GeneOhm Sciences Canada Inc 2555 Boul du Parc Technologique Qu bec QC G1P 495 Canada Made in Canada Brands are trademarks of their respective owners BD BD Logo and all other trademarks are property of Becton Dickinson and Company 2014 BD
9. xtraction Tubes A8 Dried extraction reagent containing magnetic affinity beads Proteinase K and Sample Processing Control BD MAX Sample Buffer Tube SB 2 with 25 septum caps 442819 BD MAX DNA Reagent Strip DNA Unitized Reagent Strip containing all liquid reagents and disposable pipette tips necessary for specimen processing and DNA extraction BD MAX Conical Tubes EQUIPMENT AND MATERIALS REQUIRED BUT NOT PROVIDED BD MAX System REF 441916 or 441927 e Micropipettes accurate between 2 and 1000 uL e Aerosol resistant micropipette tips e Disposable gloves lab coat e Specimen collection container s e Dry swabs e PCR Cartridges REF 437519 if applicable BD MAX DNA MMK SPC REF 442829 or BD MAX DNA MMK REF 442848 if applicable BD MAX Conical Tubes REF 437016 if applicable WARNINGS AND PRECAUTIONS e The BD MAX ExK DNA 2 is for in vitro diagnostic use e Do not use expired reagents and or materials TI T P0123 05 Do not use the kit if the label that seals the outer box is broken upon arrival Do not use reagents if the protective pouches are open or broken upon arrival Do not use reagents if desiccant is not present or is broken inside reagent pouches Do not remove desiccant from reagent pouches Close protective pouches of reagents promptly with the zip seal after each use Remove any excess air in the pouches prior to sealing Protect reagents again
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