Cowingene MTB and NTM Detection Kit(NATBox)

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

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.

The MTB/NTM Detection Kit is performed on the NATBox System. It is an automated in vitro diagnostic test system.
The NATBox Systems automate and integrate sample preparation, nucleic acid extraction and amplification, and detection of the target sequences in samples. The systems require the use of single-use cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained, cross-contamination between samples is minimized. For a full description of the system, please see the product manual of NATBox System.

 

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

 

Recommended Supporting  Reagents

REF Product Name Certification Package Size
CW07023Q Cowingene NATBox system CE 1 unit
CW09021W Cowingene Sample Diluent Reagent CE 1 mL/vial, 24 vials

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