BD MAX™ ExK™ TNA-2 442825 - BD Molecular Diagnostics
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1. BD MAX ExK TNA 2 BD MAX ExK TNA 2 442825 Cerebral spinal fluid I For use with the BD MAX System INTENDED USE The BD MAX ExK TNA 2 is intended to extract total nucleic acid TNA from cerebral spinal fluid CSF specimens The TNA Extraction Tube contains a Specimen Processing Control sequence from a proprietary Armored RNA Quant Asuragen Inc The BD MAX ExK TNA 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 Iysis TNA 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 TNA extraction Following cell lysis the released nucleic acids are captured by magnetic affinity beads The beads with the bound nucleic acids are washed and then the TNA 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 TNA may be used for applications on the BD MAX System or another PCR Amplification Detection System REAGENTS REF COMPONENT NAME QUANTITY BD MAX ExK TNA Extraction Tube B4 Dried extraction reagent containing magnetic aff2. prevent contamination 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 eatin 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 BD MAX ExK TNA 2 components are stable at 2 25 C through the stated expiration date Do not use if expired The BD MAX TNA Extraction Tubes B4 are provided in sealed pouches To protect product from humidity immediately re seal after opening The Extraction Tubes are stable for up to 14 days at 2 25 C after initial opening and re sealing of the pouch Unreconstituted Extraction Tubes are stable for up to 4 hours at 2 25 C after being removed from their protective pouch INSTRUCTIONS FOR USE Specimen Collection Collect specimen and label appropriately Collected specimens should be maintained per the conditions validated by the us
3. er Proceed to Extraction Preparation k 2 3 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 Pipette 200 uL of specimen into a BD MAX TNA 2 Sample Buffer Tube and close the tube with a septum cap Ensure complete mixing by vortexing the sample 2 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 TNA 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 excess air and close pouches with the zip seal 5 Foreach 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 Note A tube is fully seated in the strip when a click is heard Refer to Figure 1 for reagent placement in the Unitized Rea
4. gent Strip a Extraction only Posi ti Posit iti Posit Pos ion 1 Snap the TNA Extraction Tube into position 1 ion 2 Leave position 2 empty on 3 Snap a BD MAX Conical Tube into position 3 ion 4 Leave position 4 empty b Type 1 BD MMK or MMK SPC and Dried Primers and Probes Pos Pos Pos ition 1 Snap the TNA Extraction Tube into Position 1 ition 2 Snap the BD MAX TNA MMK SPC or BD MAX TNA MMK Master Mix Tube into position 2 ition 3 Snap a BD MAX Conical Tube containing dried down primer and probe mixture at a final concentration of 2X into position 3 Pos ition 4 Leave position 4 empty c Type 2 BD MMK or MMK SPC and Liquid Primers and Probes Pos Pos ition 1 Snap the TNA Extraction Tube into Position 1 ition 2 Snap the BD MAX TNA MMK SPC or BD MAX TNA MMK Master Mix Tube into position 2 follow the instructions for use accompanying that product Pos ition 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 in position 3 Pos ition 4 Leave position 4 empty d Type 3 Liquid MM with Primers and Probes Pos Pos Pos and Pos ition 1 Snap the TNA Extraction Tube into Position 1 ition 2 Leave position 2 empty ition 3 Snap a BD MAX Conical Tube into position 3 Pipette 12 5 uL of the user supplied master mix primer probe mixture at a f
5. inal concentration of 2X into the BD MAX Conical Tube in position 3 ition 4 Leave position 4 empty e Type 4 Lyophilized MM with Primers and Probes Pos Pos ition 1 Snap the TNA Extraction Tube into Position 1 ition 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 e Position 4 Leave position 4 empty f Dual Master Mix Liquid MM with Primers and Probes e Position 1 Snap the TNA Extraction Tube into Position 1 e Position 2 Snap a BD MAX Conical Tube into position 2 Pipette 12 5 uL of user supplied master mix primer and probe mixture 1 ata final concentration of 2X into the BD MAX Conical Tube in position 2 e Position 3 Snap a BD MAX Conical Tube into position 3 Pipette 25 uL of user supplied rehydration buffer into the BD MAX Conical Tube in position 3 e Position 4 Snap a BD MAX Conical Tube into position 4 Pipette 12 5 uL of user supplied master mix primer and probe mixture 2 at a final concentration of 2X into the BD MAX Conical Tube in position 4 g Dual Master Mix Dried MM with Primers and Probes e Position 1 Snap the TNA Extraction Tube into Position 1 e Position 2 Snap a BD MAX Conical Tube containing user supplied lyophilized master mix 1 into position 2 e Position 3 Snap a BD MAX Conical T
6. inity beads Proteinase K and Specimen Processing Control BD MAX ExK TNA 2 Sample Buffer Tube 442825 with 25 septum caps YA BD MAX TNA Reagent Strip TNA Unitized Reagent Strip containing all liquid reagents and disposable pipette tips necessary for specimen processing and TNA extraction BD MAX Conical Tubes e P0069 03 EQUIPMENT AND MATERIALS REQUIRED BUT NOT PROVIDED BD MAX System REF 441916 or 441927 Micropipettes accurate between 2 and 1000 uL Aerosol resistant micropipette tips Disposable gloves lab coat Specimen collection container s PCR Cartridges REF 437519 if applicable BD MAX TNA MMK SPC REF 442830 or BD MAX TNA MMK REF 442845 if applicable BD MAX Conical Tubes REF 437016 if applicable WARNINGS AND PRECAUTIONS The BD MAX ExK TNA 2 is for in vitro diagnostic use Do not use expired reagents and or materials 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 against heat and humidity Prolonged exposure to humidity may affect product performance Do not use reagen
7. ntion and National Institutes of Health Biosafety in microbiological and biomedical laboratories Chosewood L C and Wislon D E eds 2009 HHS Publication No CDC 21 1112 3 BD MAX System User s Manual US Open System version 8089571 or International version 8089570 refer to the latest revision BD Diagnostics Sparks MD USA iy y Temperature limitations Perforation wal Manufacturer Batch code Lot Catalog number gt Use by YYYY MM DD YYYY MM MM end of month IVD In vitro Diagnostic Use Medical Use Y Contains sufficient for lt n gt tests u Keep dry ME 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 Y BD Technical Information In the United States contact BD Technical Service and Support at 1 800 638 8663 or www bd com ds ml GeneOhm Sciences Canada Inc 2555 Boul du Parc Technologique Qu bec QC G1P 455 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 2015 BD
8. r each run PCR Cartridges are used on a per run AND rack basis 2 runs per cartridge and 1 cartridge per rack Figure 1 BD MAX Unitized Reagent Strip Figure 2 BD MAX System Snap in tubes Waste Aa Reservoir Pipette Tips 1 2 9 4 o ET ETETET DNA RNA 1 2 3 4 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 2 3 The BD MAX ExK TNA 2 can only be used on the BD MAX System by trained personnel Use of the BD MAX ExK TNA 2 for clinical specimen type other than CSF specimens have not been validated The BD MAX ExK TNA 2 has only been validated for use on BD MAX System software version 4 01 and subsequent releases 4 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 5 For TNA extraction IgG BSA proteins showed slight inhibition delay of Second Derivative Peak Abscissa when tested with model organisms at 2 5X LoD however expected assay results were still obtained REFERENCES 1 Clinical and Laboratory Standards Institute Protection of laboratory workers from occupationally acquired infections Approved Guideline Document M29 Refer to the latest edition 2 Centers for Disease Control and Preve
9. ts 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 re use 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 to the proper performance of this assay Due to the high analytical sensitivity of this test extreme care should be taken to preserve the purity of all materials and reagents 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 ExK TNA 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 To avoid contamination of the environment by amplicons do not break apart the BD MAX PCR Cartridge after use The seals of the BD MAX PCR Cartridges are designed to
10. ube into position 3 Pipette 25 uL of user supplied rehydration buffer into the BD MAX Conical Tube in position 3 e Position 4 Snap a BD MAX Conical Tube containing user supplied lyophilized master mix 2 into position 4 6 Click on the Run icon and enter the kit lot number for the BD MAX ExK TNA 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 lotis used 7 Navigate to the Worklist Using the pull down menu select lt ExK TNA 2 gt 8 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 9 Select the appropriate kit lot number found on the outer box from the pull down menu 10 Repeat Steps 7 9 for all remaining Sample Buffer Tubes 11 Place the Sample Buffer Tubes in the BD MAX System Rack s corresponding to the Unitized Reagent 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 12 Ifthe BD MAX System is also being used for TNA 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 The BD MAX System will automatically select the position and row on the PCR Cartridge fo
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