The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is an U.S. Food and Drug Administration (FDA) emergency use authorized, all-in-one in vitro diagnostic kit that enables specimen storage/transport, specimen preparation, as well as real-time RT-PCR-based COVID-19 detection.
Multi-target assay. Targets ORF1ab and N genes. Does not exhibit cross-reactivity with common pathogens found in the respiratory systems.
Limit of detection of 200 copies/ml.
Covers 100% of known SARS-CoV-2 sequences published on NCBI, GISAID, and NGDC1.
Enables SARS-CoV-2 detection without prior viral nucleic acid isolation or other specimen preparation procedures2.
Does not exhibit cross-reactivity with pathogens commonly found in upper and lower respiratory specimens such as:
FDA-Emergency Use Only
The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, midturbinate swabs, nasal washes and nasal aspirates from individuals who are suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is intended for use by qualified, trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is only for use under the Food and Drug Administration’s Emergency Use Authorization (EUA).
