Cowingene Mycoplasma Pneumoniae Detection Kit (NATBox)

REF: RP08023W Validated specimen: Nasopharyngeal swab, Nasopharyngeal aspirate, Bronchoalveolar lavage, Throat swab, Sputum Analytes: Mycoplasma Pneumoniae(MP)

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Cowingene Mycoplasma Pneumoniae Detection Kit (NATBox)

Intented Use

The Cowingene Mycoplasma Pneumoniae Detection Kit (MP Detection Kit) is an in vitro diagnostic test for the qualitative detection of DNA from Mycoplasma Pneumoniae (MP) in patient specimens.
The MP 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
RP08023W	Cowingene Mycoplasma Pneumoniae Detection Kit	NATBox	24 tests/kit

Specification

Detection Target

Mycoplasma Pneumoniae

Certification

CE- IVD

Storage

2-8℃ for 12 months

LoD

600 Copies/mL

Validated Specimen

Nasopharyngeal swab, Nasopharyngeal aspirate, Bronchoalveolar lavage, Throat swab

Compatible Instruments

NATBox^® Mini II

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

Recommended Supporting Reagents

REF	Product Name	Certification	Package Size
CW06021Z	Cowingene Sample Diluent Reagent	CE	10 mL/bottle,10 bottle
CW07023Q	Cowingene NATBox System	CE	1 unit
CW08021Q	Cowingene Sample Collection Kit	CE	1 test/kit