The Korean Journal of Clinical Laboratory Science : eISSN 2288-1662 / pISSN 1738-3544

Table. 7.

Table. 7.

Comparisons of FDA-approved COVID-19 diagnostic assays

RT-qPCR IAT CRISPR ELISA LFIA
Target ORF1ab, RdRp, E, S, and N gene ORF1ab, RdRp, and N gene ORF1ab, E, and N gene IgG, IgM and IgA Ab IgG and IgM Ab
Specimen URS, LRS, saliva and BAL URS, LRS, nasal and throat NPS or OPS and BAL Plasma or serum Serum, saliva or nasal swab fluids (Ab)
Day post symptoms where the target is maximum First week after symptom onset First week after symptom onset First week after symptom onset

IgM: 10∼35 days after onset

IgG: 10 days after onset

IgM: 10∼35 days after onset

IgG: 10 days after onset

Ag: before or at symp-toms onset

Assay to result time 120 min (excluding RNA extraction) 15∼60 min 30∼40 min (DETECTR)
∼60 min (SHERLOCK)
35 min 15∼20 min
Sample to result time 8 hour 1 hour 45 min∼1 hour 1∼5 hour 20∼30 min
Result type Quantitative Qualitative Qualitative Quantitative Qualitative
Sensitivity 93.4∼100% 100% 95% 87.5∼100% Ab: 82∼93.8%
Ag: 80%
Specificity 94.9∼100% 100% 100% 95∼100% Ab: 90.6∼100%
Ag: 100%
Scale of production Hard Hard Easy Easy Easy
Cost High Moderate-low Low High-moderate Low

Abbreviations: RT-PCR, reverse transcription quantitative polymerase chain reaction; IAT, isothermal amplification test; CRISPR, clustered regularly interspaced short palindromic repeat; ELISA, enzyme-linked immunosorbent assay; LFIA, lateral flow immunochromatographic assays; ORF, open reading frame; E, envelop protein; S, spike protein; N, nucleocapsid protein; RdRp, RNA dependent RNA polymerase; IgG, immunoglobulin G; IgM, immunoglobulin M; IgA, immunoglobulin A; Ab, antibody; URS, Upper respiratory specimens; LRS, lower respiratory specimens; BAL, bronchoalveolar lavage fluids; NPS, nasopharyngeal swab; OPS, oropharyngeal swab; Ag, antigen.

Reference [3].

Korean J Clin Lab Sci 2022;54:79-94 https://doi.org/10.15324/kjcls.2022.54.2.79
© 2022 Korean J Clin Lab Sci