Cowingene MTB and NTM Detection Kit (NATBox)
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 |
| 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 |
