Introduction:

COVID-19 Coronavirus Real Time PCR Kit is an In Vitro Diagnostic (IVD) reagent applying on fluorescent PCR technology and aiming at qualitatively detect Open Reading Frame gene region (ORF1a/b) and viral nucleocapsid region (N) of SARS-CoV-2 RNA from upper and lower respiratory tract specimens. 
Upper respiratory tract specimens include throat swab and nasopharyngeal swab. Lower respiratory tract specimens include sputum. 
The product is intended for use on populations suspected to have SARS-CoV-2 infection, as an aid in the diagnosis of SARS-CoV-2 infection by trained laboratory personnel on RT-PCR.

 

Advantages:

Multiplex real-time PCR detect different target specific for SARS-CoV-2
Internal control ensures the whole process reliably
Better performance makes the result more accurate
More efficient: 96 tests in 72 minutes (on an instrument)
Suitable for more mainstream instrument

Shelf life: 12 months

 

Parameters:

 

Target  ORF1a/b, N genes and RNaseP as IC
Clinical Sensitivity 100%
Clinical Specificity 99.8%
Limit of detection 350 copies/mL
Sample input volume 5μL
Sample type Nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal aspirates, nasal washes, bronchoalveolar lavage (BAL) fluid and sputum specimens.
Catalog Product     Package
JC10223-1NW COVID-19 Coronavirus Real Time PCR Kit 50 Tests/Kit

 

Certificates:

NMPA, CE, FDA-EUA, WHO-EUL, ANVISA, TGA, SAHPRA, SFDA


Download:

EUA-Fact sheet for healthcare-Bioperfectus.pdf

EUA-Fact sheet for patients-Bioperfectus.pdf

EUA-Bioperfectus-IFU.pdf

 

1K0A1902

COVID-19 Coronavirus Real Time PCR Kit

Created on:2020-11-17 16:40

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