Cowingene Mycobacterium Tuberculosis Detection Kit (Lyophilized)

REF: TB01022X validated specimen: Sputum, Bronchial washing, Cultured cell Analytes: Mycobacterium Tuberculosis(MTB)

Cowingene Mycobacterium Tuberculosis Detection Kit (Lyophilized)


 
Intented Use

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

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

 

Order Information

РЕФ Product Name Type Package Size
TB01022X Набор для обнаружения микобактерий туберкулеза Cowingene Лиофилизированный 48 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.

 

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): 500 Copies/mL

 

Specification

Detection Target

Mycobacterium tuberculosis (MTB)

Certification

CE-IVD

Storage

2-30℃ for 18 months

LoD

500Copies/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

РЕФ Product Name Certification Package Size
CW09021W Реагент для разбавления образца Cowingene CE 1 mL/vial, 24 vials
CW05021X Cowingene DNA/RNA Extraction kit CE 48тестов/набор

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