1copy COVID-19 qPCR 4plex Kit

GENERAL INFORMATION 1copy COVID-19 qPCR 4plex Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, oropharyngeal, anterior nasal, mid-turbinate nasal swab specimens as well as nasopharyngeal wash/aspirate and nasal aspirate specimens collected from individuals suspected of COVID-19 by their healthcare providers. The kit provides reagents that target the E (envelope), N (nucleocapsid protein) and RdRp (RNA dependent RNA polymerase) genes. Endogenous internal control GADPH is also included to evaluate the process of sampling and extraction of viral RNA. 1copy COVID-19 qPCR 4plex Kit provides fast analysis without extraction within 50 minutes, as well as high sensitivity of 5 copies/reaction. MATERIALS AND REAGENTS Control is used as positive control. DEPC DW is used as negative control. RESULTS INTERPRETATION If sufficient biological samples (clinical matrix) are not collected and viral load is high, E gene, N gene, and RdRp gene can be positively detected even if IPC is confirmed as negative. A positive result in single, or 2 target results may be suggestive of: a sample at concentrations near or below the limit of detection of the test a mutation in the target region in the oligo binding sites, or infection with some other Sarbecovirus (e.g. SARS-CoV or some other Sarbecovirus previously unknown to infect humans), or carry-over contamination by control or patient samples, or other factors. Invalid result is due to potential sampling error or inhibition. SENSITIVITY AND SPECIFICITY Relative sensitivity of the assay: 100% Relative specificity of the assay: 100% CE-IVD Certified