ExK DNA-4 Package Insert - BD Molecular Diagnostics
Contents
1. System Rack Start with Position 1 of Rack A i BIOS ONNE BD MAX SYSLER ANA RACK B 15 OWENE nig Figune Approved Guideline Document M29 Refer to the latest edition specimen patient using the barcode scanner or manual entry 7 Repeat Steps 1 6 for all soecimens Always move from Position 1 through Position 12 on each Rack ensuring that no positions are Temperature skipped limitation 8 Ifthe BD MAX System is also being used for DNA amplification include additional disposables as required Contains Consult 9 Load Rack s into the BD MAX System Figure 2 Ensure that sufficient instructions the placement of the Rack s corresponds to the Work List for n tests for use definition 10 Close the BD MAX System door and press Start to begin the test run Reseal pouch Figure 1 DNA Strip after use In vitro Diagnostic Use THIS PRODUCT IS SOLD UNDER LICENSE AND PURCHASE OF THIS PRODUCT DOES NOT INCLUDE RIGHTS TO USE FOR CERTAIN BLOOD Buffers AND TISSUE SCREENING APPLICATIONS NOR FOR CERTAIN INDUSTRIAL APPLICATIONS am 2 a wi oO EL m 1z rho g km shard Lu Master Mix position Conical tube position wy BD Technical Information In the United States telephone Technical Services toll free 800 638 8663 GeneOhm Sciences Canada Inc 2555 boul du Parc Technologique Qu bec Qc Canada G1P 4S5 BD BD Logo and all other trademarks are property of Becton Dickinson and Compa2. VBD MAX BD MAX ExK DNA 4 Stool 25 C REF 442851 ivo X Y For use with the BD MAX System INTENDED USE The BD MAX ExK DNA 4 is intended to extract DNA from unpreserved or preserved Cary Blair medium stool specimens The DNA Extraction Tube contains a Specimen Processing Control SPC sequence from Drosophila melanogaster GenBank AC246436 nucleotides 35779 to 35978 cloned in a pUC119 derivative GenBank U07650 1 The BD MAX ExK DNA 4 has not been validated for use with any specific analytical 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 DNA extraction and concentration No operator intervention is necessary once the specimen is loaded onto the BD MAX System The BD MAX System contains a combination of lytic and extraction reagents designed to perform cell lysis DNA extraction and removal of inhibitors Following cell lysis the released DNA is captured by magnetic affinity beads The beads with the bound DNA are washed and the DNA is eluted using 12 5 uL of Elution Buffer The solution may be prepared for PCR using neutralization buffer from the DNA strip The eluted DNA may be used for applications on the BD MAX System or another PCR Amplification Detection System REAGENTS AND SUPPLIES REF COMPONENT NAME QUANTITY DNA Extraction Tube DNA Sample Buf
3. sample processing control Pipette a total of 12 5 uL of the user supplied master mix primers and probes at a final 4 The user must validate the selected application of this product concentration of 2X into the Conical Tube in Position 3 of according to country federal provincial state local and or the DNA Strip Add user provided sample processing control accrediting organization guidelines regulations and standards to the Sample Buffer Tube Proceed to Step 3 below 3 Select the Work List tab in the Run screen on the BD MAX AE l 1 Centers for Disease Control and Prevention Biosafety in DAIEN ee a a l Microbiological and Biomedical Laboratories Chosewood LC and 4 Enter the specimen patient identification number into the BD Wilson DE eds 2009 HHS Publication number CDC 21 1112 MAATA yten Using une tie Darcoae scannar or manua Enty 2 Clinical and Laboratory Standards Institute Protection of 3 Stool obtained from preservatives other than Cary Blair medium have not been validated Start with Position 1 of Rack A Rack A is positioned on the left i i laboratory workers from occupationally acquired infections 2 5 Enter the Sample Buffer Tube barcode corresponding to each Start with Position 1 of Rack A and ensure that the SE SS EE See specimen patient ID and the Sample Buffer Tube are accurately C l matched eb Batch code 6 Place the Sample Buffer Tube containing the specimen on the number BD MAX
4. Reagents are not interchangeable between lots e Never pool reagents from different tubes even if they are from the same lot e Do not interchange caps among reagents as contamination may occur and compromise test results e Do not use reagents after expiration date e Avoid microbial and deoxyribonuclease DNase contamination of reagents at all times e Use a new 10 uL loop for each specimen e Always handle specimens as if they are infectious and in accordance with safe laboratory procedures such as those described in Biosafety in Microbiological and Biomedical Laboratories and in CLSI Document M29 e Wear personal protective equipment and non powdered disposable gloves while handling all reagents Wash hands thoroughly after performing the test e Do not pipette by mouth smoke drink or eat in areas where specimens or kit reagents are being handled e Dispose of unused reagents and waste in accordance with country federal provincial state and local regulations e Consult the BD MAX System User s Manual REF 441939 or 441942 for additional warnings precautions and procedures STORAGE AND STABILITY e BD MAX ExK DNA 4 is stable at 2 25 C through the stated expiration date The expiration date applies only to unopened kits stored as directed Do not use expired components e BD MAX ExK DNA 4 Extraction Tubes are provided in sealed pouches To protect product from humidity immediately re seal afte
5. e 1 The tube is fully seated in the strip when a click is heard Only one 1 DNA Extraction Tube should be used with each DNA Strip b If performing DNA extraction only snap the Conical Tube into Position 3 of the DNA Strip as shown in Figure 1 The tube is fully seated in the strip when a click is heard Proceed to THA HUHH Step 3 below es c If the BD MAX System is also being used for DNA amplification using BD MAX DNA MMK SPC or BD MAX DNA MMK REF 442829 or 442848 follow the instructions for use accompanying that product Snap the MM tube into Position 2 and snap the Conical tube into Position 3 of the DNA Strip as shown in Figure 1 The tubes are fully seated in the strip when a click is heard Pipette 12 5 uL of primer and probe mixture at a final concentration of 2X into the Conical Tube in Position 3 of the DNA Strip Proceed to Step 3 LIMITATIONS OF THE PROCEDURE below 1 The BD MAX ExK DNA 4 can only be used on the BD MAX d If the BD MAX System is being used for DNA amplification System by trained personnel with a user supplied master mix snap a Conical Tube into 2 Use of the BD MAX ExK DNA 4 for clinical specimen types Position 3 of the DNA Strip as shown in Figure 1 The tube is other than those specified have not been validated fully seated in the strip when a click is heard Prepare liquid primer and probe mixture for target s and user provided
6. fer Tube SB 7 442851 DNA Strip Septum Conical Tube EQUIPMENT AND MATERIALS REQUIRED BUT NOT PROVIDED 1 BD MAX System REF 441916 or 441927 2 Calibrated loop 10 uL 3 Disposable gloves lab coat 4 Specimen collection container s WARNINGS AND PRECAUTIONS e This kit is for in vitro diagnostic use e Do not use this kit if the outer carton safety seal is broken e Do not use this kit if the packaging is damaged upon arrival e Do not use reagents if their protective pouches are open or broken upon arrival e Do not use reagents if desiccant is not present or broken inside protective pouches e Do not remove desiccant from protective pouches e Close protective pouches promptly with the zip seal after each use Remove any excess air in the pouches prior to sealing e Do not use reagents if their foil seal has been opened or damaged DNA Extraction Tube DNA Strip e Proceed with caution when using chemical solutions as Master Mix and Extraction Tube barcode readability may be altered e Check DNA Strips for proper liquid fills ensure that the liquids are at the bottom of all three 3 buffer tubes if necessary gently tap P0152 01 1 2 the DNA Strips until the liquids move to the bottom of tubes see Figure 1 e Check DNA Strips to ensure that all four 4 pipette tips are present see Figure 1 e Protect reagents against heat and humidity Prolonged exposure to humidity may affect product performance e
7. ny 2013 BD Made in Canada P0152 01 2 2 2013 01
8. r opening Reagent tubes are stable for up to 7 days at 2 8 C after initial opening and re sealing INSTRUCTIONS FOR USE Specimen Collection 1 Collect specimen and label appropriately Note Preserved specimens must be obtained from Cary Blair medium Other preservatives have not been evaluated 2 Collected specimens should be maintained per the conditions validated by the user 3 Proceed to Extraction Preparation 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 Stool Acquire specimen with a 10 ul loop Note For unpreserved stool specimens sample from liquid portion of stool specimen where possible as solid components may cause inhibition of the PCR reaction Distribute sample into a BD MAX DNA Sample Buffer Tube SB 7 and close the tube with a septum cap Ensure complete mixing by vortexing the sample 2 Proceed to BD MAX Operation BD MAX Operation Refer to the BD MAX System User s Manual REF 441939 or 441942 for programming and setup instructions 1 For each specimen to be tested place one 1 DNA Strip on the BD MAX System Rack 2 Assemble BD MAX DNA Strips 2013 01 a Snap the appropriate DNA Extraction Tube into Position 1 of Figure 2 BD MAX System the DNA Strip as shown in Figur
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