BD MAX™ TNA MMK(SPC) 442830

BD MAX™ TNA MMK(SPC) 442830
BD MAX™ TNA MMK(SPC)
(With Primer/Probe for Process Control)
For Laboratory Use
May be used with the BD MAX System or another PCR Amplification/Detection System.
 442830
P0142(03)
2015-02

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
REF
442830
COMPONENT NAME
BD MAX™ TNA MMK(SPC) Master Mix (C1)
Dried PCR Master Mix containing dNTPs, RT-polymerase, and Specimen Processing
Control-specific molecular primers and probes.
BD MAX™ TNA Primers and Probes Diluent
QUANTITY
24
0.6 mL
EQUIPMENT AND MATERIALS REQUIRED BUT NOT PROVIDED
•
BD MAX™ System: REF 441916 or 441927; or another PCR Amplification/Detection System
•
Micropipettes (accurate between 2 and 1000 µL)
•
Aerosol resistant micropipette tips
•
Disposable gloves/lab coat
•
BD MAX™ ExK™ TNA; or another TNA or RNA extraction method
•
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 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 reagents if the foil has been broken or damaged.
•
Do not mix reagents from different pouches and/or kits and/or lots.
P0142(03)
•
•
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.
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 before 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.
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STORAGE AND STABILITY
•
The BD MAX TNA MMK(SPC) product is stable at 2 – 25 °C through the stated expiration date. Do not use if expired.
•
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 reverse transcription. Users must optimize the
conditions below based on the desired application.
Activation
RT
Temperature Range
80 - 90 °C
55 - 65 °C
Time Range
300-600s
900-1800s
BD MAX System Operation
Note: Refer to the BD MAX System User’s Manual1 for detailed instructions (Operation section). Refer to the
BD MAX ExK TNA Product Insert for instructions.
For a 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 µL
User Supplied Primers and Probes (in 1X TE)
Maximum 8.25 µL1
Sufficient Molecular Grade
12.5 µL total
Water to a Final Volume of 12.5 µL
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.
4.
Pipette 12.5 µL of the liquid primer and probe mixture into Position 3 of the Unitized Reagent Strip being careful to avoid
bubble formation.
Continue with instructions for the BD MAX ExK TNA product.
2
PCR Only on BD MAX System or Use on 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 µL (1X).
COMPONENT
VOLUME
Primer and Probe Diluent (5.88X)
2.13 µL
User Supplied Primers and Probes (in 1X TE)1
Combined volume not to exceed 10.12 µL
TNA or RNA Target1
6.25 µL of Elution Buffer
Molecular Grade Water
Final volume of 12.5 µL total
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.

Temperature limitations

Manufacturer

Catalog number

Keep away from light

Batch code (Lot)

Use by / YYYY-MM-DD / YYYY-MM (MM = end of month)

Contains sufficient for <n> tests

Consult Instructions for Use
H360 May damage fertility or the unborn child.

P280 Wear protective gloves/protective clothing/eye
protection/face protection.
Keep dry
Danger
P308+P313 IF exposed or concerned: Get medical
advice/attention.

P405 Store locked up.
Perforation
P501 Dispose of contents/container in accordance with
local/regional/national/ international regulations.
3
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
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: [email protected]

Technical Information: In the United States, contact BD Technical Service and Support at 1.800.638.8663 or www.bd.com/ds.
 GeneOhm Sciences Canada, Inc.
2555 Boul. du Parc Technologique
Québec, QC, G1P 4S5, 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
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