COVID-19 Coronavirus Real Time PCR Kit

COVID-19 Coronavirus Real Time PCR Kit was developed and manufactured by bioPerfectus Technologies

Size: 50 Tests
Run Time: 72 Minutes
Sample Type: Nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, midturbinate nasal swabs, nasal aspirates, nasal washes, bronchoalveolar lavage (BAL) fluid and sputum
Species Sample: Human
Sample Size: 5 µL
Alternative Names: Serology, Coronavirus, COVID-19, Corona, Serological
IVD, CE-Marked

Assay Principle

The oligonucleotide primers and probes for specific detection of SARS-CoV-2 are selected from regions of Open Reading Frame 1ab (ORF1ab) and the nucleocapsid gene (N) of the SARS-CoV-2 genome. The kit includes primers/probes that are specific for the ORF1ab gene (probe labeled with FAM) and N gene (probe labeled with VIC) of SARS-CoV-2. In addition, the kit also contains primers and a probe (labeled with CY5) for the human RNase P gene as an endogenous internal control for specimen integrity, nucleic acid isolation, amplification and detection.
RNA isolated and purified from upper and lower respiratory tract specimens is reverse transcribed to cDNA and amplified in a Real-time PCR instrument using one-step Master Mix. Probes consist of a reporter dye at the 5’ end and quenching dye at the 3’ end. The fluorescent signals emitted from the reporter dye are absorbed by the quencher. During PCR amplification, probes hybridized to amplified templates are degraded by the Taq DNA polymerase with 5’-3’ exonuclease activity, thereby separating the reporter dye and quencher and generating fluorescent signals that increase with each cycle. The PCR instrument automatically draws a real-time amplification curve for each optical channel based on the signal change, and calculates cycle threshold (Ct) values (the point at which fluorescence is detectable above background) that are interpreted by the operator to determine the presence/absence of SARS-CoV-2 RNA.

Information for US Customers

During this crisis, steps are being taken to ensure that we can provide access to quality products for diagnostic testing. The Food and Drug Administration (FDA) has issued guidance which allows for distribution of the serological tests. At this time, the kits are released for sale in the United States under the provisions outlined in Section D of Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.

FDA EUA Number: EUA201047

Per the aforementioned guidance, the following statements are required:

• This test has not been reviewed by the FDA.
• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus.
• Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
• Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

This kit is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, and not for at home testing.

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