Cowingene Influenza A/B and RSV Detection Kit ( NATBox )

REF: RP03023W Validated specimen: Nasopharyngeal swab, Nasopharyngeal aspirate, Bronchoalveolar lavage, Throat swab Analytes: Influenza A virus (Flu A),Influenza B virus (Flu B),Respiratory syncytial virus(RSV)

Cowingene Influenza A/B and RSV Detection Kit (NATBox)


 
Intented Use

The Cowingene Influenza A/B and RSV Detection Kit (FluA&B&RSV Detection Kit) is an in vitro diagnostic test for the qualitative detection of RNA from Influenza A/B and Respiratory Syncytial Virus (RSV) in patient specimens. The test utilizes amplification of target RNA by the Polymerase Chain Reaction (PCR) for the detection of Influenza A/B and Respiratory Syncytial Virus in a single analysis. The test specifically identifies Influenza A/B and Respiratory Syncytial Virus.

The FluA&B&RSV 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
RP03023W Cowingene Influenza A/B and RSV Detection Kit NATBox 24 tests/kit

 

Specification

Detection Target
Influenza A, Influenza B, Respiratory Syncytial Virus (RSV)
Certification
CE- IVD
Storage
2-8℃ for 12 months
LoD
Influenza A: 400 Copies/mL
Influenza B: 400 Copies/mL
RSV: 400 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

 

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