Table 1.
SARS-CoV-2 DETECTR, RT-LAMP/Cas12 | CDC SARS-CoV-2 qRT-PCR | |
---|---|---|
Target | E gene & N gene* | N gene (3 amplicons, N1, N2, and N3) |
Sample control | RNase P | RNase P |
Limit of Detection | 10 copies/µL input | 3.2 copies/µL input |
Assay reaction time (approximate) | 30–40 min | 120 min |
Assay sample-to-result time (approximate) | 45 min (with manual RNA extraction) | 4 hr (including RNA extraction) |
Assay results | Qualitative | Quantitative |
Assay components | RT-LAMP (62°C, 20–30 min) Cas12 (37°C, 10 min) Lateral flow strip (RT, 2 min; no additional time if using fluorescence readout) |
UDG digestion (25°C, 2 min), reverse transcription (50°C, 15 min), denature (95°C, 2 min) amplification, (95°C, 3 sec; 55°C 30 sec; 45 cycles) |
Bulky instrumentation required | No | Yes |
FDA EUA approval | Pending clinical validation | Yes |
E gene primers target same amplicon region as in the WHO protocol; N gene primers target same N2 amplicon region as in the CDC protocol