DiaPlexQ™ Novel Coronavirus Detection Kit - India CDSCO Medical Device Registration

Product Information

DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit is a real-time RT-PCR test intended for the presumptive qualitative detection of nucleic acid from the SARS-CoV-2 in respiratory specimens such as nasopharyngeal swab or oropharyngeal swab or sputum from individuals suspected of COVID-19 that meet the CDC SARS-CoV-2 clinical criteria. Results are for the presumptive detection and 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 active infection with SARS-CoV -2 but do not rule out bacterial infection or co-infection with other viruses. Basic principal of this kit is Real-time PCR method, which is able to detect specific target gene into total RNA. This is a OneStep Multiplex RT-qPCR based detection with high-specificity & is intended for use by trained clinical laboratory professionals.