National Health Insurance Service approved day | Jul 2, 2020 | Aug 6, 2020 | Dec 14, 2020 | Not approved |
Method | Real-time RT-PCR | Real-time RT-PCR | Immunochromatography | Immunochromatography/ELISA |
Analyte/target | RNA/SARS-CoV-2 specific gene | RNA/SARS-CoV-2 specific gene | Antigen/viral protein | Antibody/SARS-CoV-2 specific IgG, IgM |
Specimen | NP swab, OP swab, sputum | NP swab, OP swab | NP swab, OP swab | Blood |
Test time | ≤6 hr | 1–2 hr | 15–30 min | 10–15 min (ELISA: 1–2 hr) |
Interpretation of result(positive/negative) | Target gene amplification (Ct value cut-off) | Target gene amplification (Ct value cut-off) | Visual inspection | Visual inspection (ELISA: semi-quantitative value) |
Advantage | Highest sensitivity | High sensitivityShort test time | Short test timePoint-of-care testing | Short test time Point-of-care testing |
Disadvantage | LaboratoriesExperts Long test time | Probability of false negativePositive result need to be confirmed by diagnostic PCR | Low sensitivity (high false negative rate)Positive result need to be confirmed by diagnostic PCR | Not diagnostic tests Cross-reactivity |
Purpose | COVID-19 confirmation | Excluding COVID-19 in emergency | Identifying the most infectious cases | Identifying past infectionSerological investigation |