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.
|Target||ORF1a/b, N genes and RNaseP as IC|
|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.|
|JC10223-1NW||COVID-19 Coronavirus Real Time PCR Kit||50 Tests/Kit|
NMPA, CE, FDA-EUA, WHO-EUL, ANVISA, TGA, SAHPRA, SFDA
EUA-Fact sheet for healthcare-Bioperfectus.pdf
EUA-Fact sheet for patients-Bioperfectus.pdf
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