BD MAX™ TNA MMK(SPC) 442830
Contents
1. GBD MAX TNAMMK SPC _ 7 BD MAX TNA MMK SPC 442830 With Primer Probe for Process Control P0142 03 For Laboratory Use 2015 02 May be used with the BD MAX System or another PCR Amplification Detection System 25 C z PRODUCT DESCRIPTION BD MAX TNA MMK SPC is a dried down PCR reagent mix containing dNTPs Hot Start DNA polymerase with a reverse transcriptase function buffers as well as forward and reverse primers and a fluorophore labeled TaqMan Probe Excitation 680 nm Emission 715 nm which are used to amplify a Specimen Processing Control SPC BD MAX TNA MMK SPC contains primers and probe sequences from a proprietary armored RNA Quant Asuragen Inc REAGENTS COMPONENT NAME QUANTITY BD MAX TNA MMK SPC Master Mix C1 Dried PCR Master Mix containing dNTPs RT polymerase and Specimen Processing W724 442830 Control specific molecular primers and probes BD MAX TNA Primers and Probes Diluent 0 6 mL EQUIPMENT AND MATERIALS REQUIRED BUT NOT PROVIDED e BD MAX System REF 441916 or 441927 or another PCR Amplification Detection System e Micropipettes accurate between 2 and 1000 uL e Aerosol resistant micropipette tips e Disposable gloves lab coat e BD MAX ExK TNA or another TNA or RNA extraction method e Molecular grade water WARNINGS AND PRECAUTIONS The BD MAX TNA MMK SPC is for Laboratory Use Do not use expired reagents and or materials Do not2. face protection a Keep dry Danger P308 P313 IF exposed or concerned Get medical advice attention P405 Store locked up P501 Dispose of contents container in accordance with local regional national international regulations Perforation min The purchase of this product allows the purchaser to use it for amplification and detection of nucleic acid sequences for diagnostic research purposes No general patent or other license of any kind other than this specific right of use from purchase is granted hereby 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 This product is subject to an agreement between Life Technologies Corporation and Becton Dickinson and Company and the manufacture use sale or import of this product may be subject to one or more of U S patents pending applications and corresponding foreign equivalents owned by Life Technologies Corp The purchase of this product conveys to the buyer the non transferable right to use the purchased amount of the product and components of the product for use in assays for nucleic acid amplification or detection for the purpose of identifying microorganisms in human diagnostics The buyer cannot use this product or its components for manufacturing or for therapeutic or prophylactic use or sell or otherwise transfer this product or its
3. components to any third party or use for any use other than use in human diagnostics For information on purchasing a license to this product for purposes other than use in human diagnostics contact Life Technologies Corporation Out Licensing 5791 Van Allen Way Carlsbad CA 92008 USA email outlicensing lifetech com BD Technical Information In the United States contact BD Technical Service and Support at 1 800 638 8663 or www bd com ds wl GeneOhm Sciences Canada Inc 2555 Boul du Parc Technologique Qu bec QC G1P 455 Canada Made in Canada TaqMan is a registered trademark of Roche Molecular Systems Inc Brands are trademarks of their respective owners BD BD Logo and all other trademarks are property of Becton Dickinson and Company 2015 BD
4. e transcription Users must optimize the conditions below based on the desired application Temperature Range Time Range Activation 80 90 C 300 600s RT 55 65 C 900 1800s BD MAX System Operation Note Refer to the BD MAX System User s Manual for detailed instructions Operation section Refer to the BD MAX ExK TNA Product Insert for instructions Fora Type 2 BD MMK or MMK SPC and Liquid Primers and Probes 1 For each specimen to be extracted and amplified using a BD MAX ExK TNA product assemble a Unitized Reagent Strip by Snapping a Master Mix Tube into Position 2 and a BD MAX Conical Tube into position 3 of the Unitized Reagent Strip 2 Prepare a 2X liquid primer and probe mixture for target s For each specimen to be extracted and amplified prepare COMPONENT VOLUME TNA Primer and Probe Diluent 5 88X 4 25 uL User Supplied Primers and Probes in 1X TE Maximum 8 25 WL Sufficient Molecular Grade Water to a Final Volume of 12 5 uL 12 5 uL total 1The user Supplied primer s and probe s in the formulation above should be added at 2X the final desired reaction concentration Primer and Probe volume determined by user based on desired final concentration 3 Pipette 12 5 uL of the liquid primer and probe mixture into Position 3 of the Unitized Reagent Strip being careful to avoid bubble formation 4 Continue with instructions for the BD MAX ExK TNA product PCR Only on BD MAX System or Use o
5. n Another PCR Amplification Detection System Refer to other TNA or RNA Extraction Method Procedure or other PCR Amplification Detection System User s Manual 1 For each Master Mix Tube combine with primers probe target TNA or RNA Primer and Probe Diluent Elution Buffer and sufficient Molecular Grade water to a final volume of 12 5 uL 1X COMPONENT VOLUME Primer and Probe Diluent 5 88X 2 13 ul User Supplied Primers and Probes in 1X TE TNA or RNA Target Combined volume not to exceed 10 12 uL 6 25 uL of Elution Buffer Molecular Grade Water Final volume of 12 5 uL total Molecular urade Water IMT VOIUME OF Le ph toal S 1The user supplied primer s probe s and target RNA and DNA or RNA only in the formulation above should be added at the final desired reaction concentration 1X Primer s probe s and target RNA and DNA or RNA only volume determined by user based on desired final concentration REFERENCES 1 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 y Temperature limitations Batch code Lot taal Manufacturer ia Use by YYYY MM DD YYYY MM MM end of month REF Catalog number Y Contains sufficient for lt n gt tests Q Keep away from light Cli Consult Instructions for Use H360 May damage fertility or the unborn child P280 Wear protective gloves protective clothing eye protection
6. re manipulating reagents and cartridges The laboratory should routinely perform environmental monitoring to minimize the risk of cross contamination 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 reagents are being handled Dispose of unused reagents and waste in accordance with local state provincial and or federal regulations Consult the user manual of the PCR amplification detection system use for additional warnings precautions and procedures Consult the instructions for use of the DNA extraction kit for additional warnings precautions and procedures STORAGE AND STABILITY e The BD MAX TNA MMK SPC product is stable at 2 25 C through the stated expiration date Do not use if expired e The TNA MMK SPC Master Mix C1 Tubes are provided in sealed pouches To protect product from light and humidity immediately re seal after opening The Master Mix Tubes are stable for up to 14 days at 2 25 C after initial opening and re Sealing of the pouch Unreconstituted Master Mix Tubes are stable for up to 4 hours at 2 25 C after being removed from their protective pouch INSTRUCTIONS FOR USE Note The Hot Start DNA polymerase contained in the PCR reagent mix requires hot start activation The following temperature and time ranges are recommended for activation and revers
7. 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 e Protect reagents against heat and humidity Prolonged exposure to humidity may affect product performance e Do notuse reagents if the foil has been broken or damaged Do not mix reagents from different pouches and or kits and or lots E P0142 03 e Proceed with caution when using chemical solutions as Master Mix 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 MMK SPC 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 befo
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