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.
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%