Cowingene MTB and NTM Detection Kit（NATBox）

REF: TB02023W Validated specimen: Sputum Analytes：Cartridge ; Mycobacterium Tuberculosis(MTB),Mycobacteria( consists of about 170 species of mycobacteria )

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Cowingene MTB and NTM Detection Kit (NATBox)

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

REF	Product Name	Type	Package Size
TB02023W	Cowingene MTB and NTM Detection Kit	NATBox	24 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) and other bacteria included as nontuberculous mycobacteria (NTM)
Certification	CE-IVD
Storage	2-8℃ for 12 months
LoD	MTB: 500 Copies/mL NTM: 500 Copies/mL
Validated Specimen	Sputum
Compatible Instruments	NATBox® Mini II