Cowingene Mycobacterium Tuberculosis Detection Kit (NATBox)

REF: TB01023W validated specimen: Sputum Analytes:1 cartridge ; Mycobacterium Tuberculosis(MTB)

Cowingene Mycobacterium Tuberculosis Detection Kit (NATBox)


 
Intented Use

The Cowingene Mycobacterium Tuberculosis Detection Kit (MTB Detection Kit) is an in vitro diagnostic test for the in vitro qualitative detection of DNA from Mycobacterium tuberculosis (MTB) in patient sputum specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) for the detection of MTB in a single analysis.

Order Information

REFProduct NameTypePackage Size
TB01023WCowingene Mycobacterium Tuberculosis Detection KitNATBox24 tests/kit

 

Storage and Handling Requirements

A. Reagents can be stored at 2-8℃ for 12 months
B. Reagents can be transported at 2-8℃ for no more than 15 days
C. Once opened, the lysis buffer, positive control and negative control can be stored at 2-8℃ for 1 month
D. Once the cartridge added with lysis buffer, please use it within 30 minutes
E. Do not use reagents past expiration date indicated on the package
F. Protect from light
G. Prior to use, remove reagents from refrigerator and allow them to equilibrate to room temperature for 5 minutes
H. Do not freeze for storage

 

Specification

Detection Target

Mycobacterium tuberculosis (MTB)

Certification

CE-IVD

Storage

2-8℃ for 12 months

LoD

500Copies/mL

Validated Specimen

Sputum

Compatible Instruments

NATBox® Mini II

 

Recommended Supporting  Reagents

REFProduct NameCertificationPackage Size
CW07023QCowingene NATBox systemCE1 unit
CW09021WCowingene Sample Diluent ReagentCE1 mL/vial, 24 vials

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