Cowingene MTB and NTM Detection Kit (Lyophilized)

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

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

Specification

Recommended Supporting  Reagents