BioCore 2019-nCoV Real Time PCR Kit - India CDSCO Medical Device Registration

Product Information

BioCore 2019-nCoV Real Time PCR Kit is a reverse-transcription Real time PCR test intended for qualitative detection of nucleic acid from the 2019-nCoV in upper respiratory specimens (BioCore 2019-nCoV Real Time PCR Kit) and lower respiratory specimens (such as sputum, bronchioalveolar lavage (BioCore 2019-nCoV Real Time PCR Kit), and tracheal aspirates) from patients suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (BioCore 2019-nCoV Real Time PCR Kit), 42 U.S.C. §263a, to perform high complexity tests. Results are for the identification of 2019-nCoV RNA. The 2019-nCoV 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 2019-nCoV 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 BioCore 2019-nCoV Real Time PCR Kit is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The BioCore 2019-nCoV Real Time PCR Kit is only for use under the Food and Drug Administration’s Emergency Use Authorization