This “Gold Standard” RT-qPCR test demonstrated 100.0% accuracy in clinical trials and was used to help Korea contain its COVID-19 outbreak before receiving FDA EUA authorization on May 21, 2020.
Intended Use Real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in individuals suspected of COVID-19 infection.
Who Can Perform Testing
CLIA-certified laboratories qualified to perform high complexity tests.
Time to Result
Approximately 2-4 hours
Sample Types Oropharyngeal and nasopharyngeal swab specimens, anterior nasal and mid-turbinate nasal swabs, nasopharyngeal wash/aspirate or nasal aspirate specimens, bronchioalveolar lavage (BAL), tracheal aspirates, and sputum.
Probe Targets Two SARS-CoV-2 genome targets in RdRp, one target in N.
Limit of Detection 500 copies per mL
Internal Control — Human β-globin gene
Positive Control — N gene, RdRp gene; Human β-globin gene
Negative Control — DEPC-treated demineralized water
Components 1100µL Reaction Mixture — Reverse transcriptase, DNA polymerase, RNase Inhibitor, DW
550µL Primer/Probe mix
50µL Positive Control — N gene & RdRp gene plasmid, Human β-globin gene plasmid
500µL Negative Control — DEPC-treated demineralized water
Storage & Handling
Store at –20°C; Use within 3 months of opening; Thaw reagents except Enzyme Mix at room temperature before use; Place all reagents on ice once thawed during entire test procedure; Place Enzyme Mix on ice during entire test procedure; Avoid excessive freeze/thaw cycles; Vortex and spin down reagents before each use.
Sample Collection Kit (Recommended)
RNA Extraction Kit (Required)
PCR Instruments (Required)