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Cowingene Respiratory Pathogen Panel Detection Kit-RP Pannel7 (Lyophilized)

REF:RP14022U Validated sample type: nasopharyngeal swabs Analytes: 2 tubes

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Cowingene Respiratory Pathogen Panel Detection Kit (Lyophilized)

Intented Use

The Cowingene Respiratory Pathogen Panel Detection Kit (RPP Detection Kit) is an in vitro diagnostic test for the qualitative detection of respiratory pathogens in patient specimens. The test utilizes amplification of target RNA by the Polymerase Chain Reaction (PCR) for the detection of respiratory pathogens in a single analysis. The test specifically identifies different respiratory pathogens.
This kit (RPP 7 Detection Kit) is intended for the qualitative detection of Influenza A virus(Flu A), Influenza B virus(Flu B), Metapneumovirus (MPV), Respiratory syncytial virus (RSV), Adenovirus(AdV), Mycoplasma pneumoniae (MP), and SARS-Cov-2 (SARS2).

Order Information

REF	Product Name	Type	Package Size
RP14022U	Cowingene Respiratory Pathogen Panel Detection Kit	Lyophilized	16 tests/kit

Specification

Detection Target

Influenza A virus(Flu A), Influenza B virus(Flu B), Metapneumovirus (MPV), Respiratory syncytial virus (RSV), Adenovirus(AdV), Mycoplasma pneumoniae (MP), and SARS-Cov-2 (SARS2).

Certification

CE- IVD

Storage

2-30℃ for 18 months.

LoD

Influenza A: 400 Copies/mL
Influenza B: 400 Copies/mL
Metapneumovirus: 400 Copies/mL
Respiratory syncytial virus: 400 Copies/mL
Adenovirus: 400 Copies/mL
Mycoplasma pneumoniae: 400 Copies/mL
SARS-Cov-2: 400 Copies/

Validated Specimen

Nasopharyngeal swabs

Compatible Instruments

Open real time PCR machine with channels FAM, VIC/HEX, ROX, CY5, CY5.5/Qusar705 (such as Bio-Rad CFX96, etc.

Storage and Handling Requirements

A. Reagents can be stored at 2-30℃ for 18 months.
B. Reagents can be transported at 2-30℃ for no more than 15 days.
C. Do not use reagents past expiration date indicated on outside of package.
D. Protect from light.
E. Once opened, Buffer Lypbeads is valid for 7 days at 2-8℃.
F. Once added PCR Solution, positive control, negative control and Primer Lyobeads 1 to 2 are valid for 7 days at 2-8℃, 1 month below -20℃. Repeated freezing and thawing should be limited to 10 cycles.

Recommended Supporting Reagents

REF	Product Name	Certification	Package Size
CW01021Y	Cowingene Viral DNA/RNA Column	CE	50 tests/kit
CW02021Z	Cowingene Sample Release Reagent	CE	100 mL(10*10mL)
CW05021X	Cowingene DNA/RNA Extraction kit	CE	48 tests/kit
CW08021Q	Cowingene Sample Collection Kit	CE	1 test/kit