Cowingene MTB and NTM Detection Kit (Lyophilized)

REF: TB02022X Validated specimen: Human Sputum, Bronchial washing Analytes:1 tube ; Mycobacterium Tuberculosis(MTB),Mycobacteria( consists of about 170 species of mycobacteria )

Cowingene MTB and NTM Detection Kit (Lyophilized)


 
Intented Use

The MTB/NTM Detection Kit is an in vitro diagnostic test for the qualitative detection of DNA from Mycobacterium tuberculosis (MTB) and other bacteria included as nontuberculous mycobacteria (NTM) in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) for the detection of MTB/NTM in a single analysis. The test specifically identifies MTB and NTM.

Order Information

REFProduct NameTypePackage Size
TB02022XCowingene MTB and NTM Detection KitLyophilized48 tests/kit

 

Storage and Handling Requirements

A. Reagents can be stored at 2-30℃ for 18 months.
B. Reagents can be transported at 2-30℃ for no more than 15 days.
C. Do not use reagents past expiration date indicated on outside of package.
D. Protect from light.
E. Once opened, Buffer Lypbeads is valid for 7 days at 2-8℃.
F. Once added PCR Solution, positive control, negative control and Primer Lyobeads are valid for 7 days at 2-8℃, 1 month below -20℃. Repeated freezing and thawing should be limited to 10 cycles.

 

Specification

Detection Target

Mycobacterium tuberculosis (MTB) and other bacteria included as nontuberculous mycobacteria (NTM)

Certification

CE-IVD

Storage

2-30℃ for 18 months

LoD

MTB: 500 Copies/mL
NTM: 500 Copies/mL

Validated Specimen

Human Sputum, Bronchial washing

Compatible Instruments

Open real time PCR machine with channels FAM, VIC/HEX, ROX, CY5, i.e. ABI 7500, Roche 480, Bio-Rad CFX96, etc.

 

Recommended Supporting  Reagents

REFProduct NameCertificationPackage Size
CW09021WCowingene Sample Diluent ReagentCE1 mL/vial, 24 vials
CW05021XCowingene DNA/RNA Extraction kitCE48 tests/kit
CW05021NCowingene DNA/RNA Extraction kitCE40 tests/kit
CW05021MCowingene DNA/RNA Extraction kitCE64 tests/kit
CW11022Q-16NATPure SystemCECWNP-16
CW11022Q-32NATPure SystemCECWNP-32

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