Cowingene Respiratory Pathogen Panel Detection Kit (Liquid)

REF: RP14021W validated specimen: Nasopharyngeal swab, Nasopharyngeal aspirate, Bronchoalveolar lavage, Throat swab Analytes: 2 tubes; Flu A, Flu B, MPV, RSV, AdV, MP, SARS2

Cowingene Respiratory Pathogen Panel Detection Kit (Liquid)


 
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).
Validated specimen including nasopharyngeal swab, nasopharyngeal aspirate, bronchoalveolar lavage, throat swab. For sample collection, it is recommended to refer to the laboratory technical guide.

 

 

Order Information

РЕФ Product Name Type Package Size
RP14021W Cowingene Respiratory Pathogen Panel Detection Kit Течност 24 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
≤-20℃ 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/mL
Validated Specimen
Nasopharyngeal swab, Nasopharyngeal aspirate, Bronchoalveolar lavage, Throat swab
Compatible Instruments
Open real time PCR machine with channels FAM, VIC/HEX, ROX, CY5, i.e. ABI 7500, Roche 480, Bio-Rad CFX96, etc.

 

Performance Characteristics

1. Use the kit to detect the company positive reference panels and company negative reference panels, and the results should all meet the test requirements. 

2. Repeatability: Use the kit to detect the repeatability reference panels and CV≤5% should be calculated based on the Ct (n=10). 

 

Storage and Handling Requirements

A. Reagents can be stored at≤-20℃ for 18 months
B. Reagents can be transported at≤-20℃ for no more than 15 days
C. Do not use reagents past expiration date indicated on outside of package
D. Protect from light
E. No freeze-thawing for more than 5 cycles
F. Once opened, reagent is valid for 7 days at 2-8℃
G. Prior to use, remove reagents from freezer and allow them to thaw at least 30 minutes at room temperature
H. Vortex reagents prior to each use
I. Do not store in frost free freezer

 

Recommended Supporting  Reagents

РЕФ Product Name Certification Package Size
CW02021Z Реагенс за ослобађање узорка Цовингене CE 100mL(10*10mL)
CW05021X Cowingene DNA/RNA Extraction kit CE 48 тестова/комплет
CW02021Z Реагенс за ослобађање узорка Цовингене CE 100mL(10*10mL)
CW08021Q Комплет за прикупљање узорака Цовингене CE 1test/kit

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