Cowingene MTB and NTM Detection Kit (Liquid)

REF: TB02021X validated specimen: Sputum, Bronchial washing, Cultured cell Analytes:1 tube ; Mycobacterium tuberculosis (MTB) and other bacteria included as nontuberculous mycobacteria (NTM)

Cowingene MTB and NTM Detection Kit (Liquid)


 
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.

The MTB/NTM Detection Kit adopts the method of PCR amplification combined with fluorescent probes, to select the conserved regions specific to MTB and NTM as the detection target genes, and an endogenous internal control is introduced as a quality control of the kit.

 

Order Information

RIF. Product Name Type Package Size
TB02021X Cowingene MTB and NTM Detection Kit Liquido 48 tests/kit

 

Storage and Handling Requirements

A. Reagents can be stored at≤-20℃ for 18 months
B. Reagents can be transported at≤-20℃ for no more than 15 days
C. Do not use reagents past expiration date indicated on outside of package
D. Protect from light
E. No freeze-thawing for more than 5 cycles
F. Once opened, reagent is valid for 7 days at 2-8℃
G. Prior to use, remove reagents from freezer and allow them to thaw at least 30 minutes at room temperature
H. Vortex reagents prior to each use
I. Do not store in frost free freezer

 

Performance Characteristics

1. Use the kit to detect the company positive reference panels and company negative reference panels, and the results should all meet the test requirements.
2. Repeatability: Use the kit to detect the repeatability reference panels and CV≤5% should be calculated based on the Ct (n=10).
3. Limit of Detection (LoD):
MTB: 500 Copies/mL
NTM: 500 Copies/mL

 

Specification

Detection Target

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

Certification

CE-IVD

Storage

≤-20℃ for 18 months

LoD

MTB: 500 Copies/mL

NTM: 500 Copies/mL

Validated Specimen

Sputum, Bronchial washing, Cultured cell

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

RIF. Product Name Certification Package Size
CW09021W Reagente diluente per campioni di Cowingene CE 1 mL/vial, 24 vials
CW05021X Cowingene DNA/RNA Extraction kit CE 48 test/kit

Scaricamento

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