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. 2020 Aug 26;40(8):857–868. doi: 10.1002/phar.2439

Table 2.

Comparison of In Vitro SARS‐CoV‐2 Tests Granted Emergency Use Authorizations by the US FDA

Molecular Antigen Serology
Test type Viral Viral Antibody
Diagnostic test Yes Yes No
Description Nucleic acid amplification test to detect viral RNA Detects viral proteins in the nasal cavity Detects the presence of IgA, IgM & IgG antibodies against SARS‐CoV‐2
Measure Current infection with SARS‐CoV‐2 Current infection with SARS‐CoV‐2 Past exposure to SARS‐CoV‐2
Platform technology RT‐PCR, LAMP, CRISPR Lateral flow Lateral flow, ELISA, CIA
Sample type Nasal or throat swab, saliva, bronchoalveolar lavage fluid Nasal or throat swab Blood draw (plasma, serum, whole blood) or finger stick
Testing window Days 1–28 after symptom onset, optimal days 3–12 Days 1–28 after symptom onset, optimal days 3–12 IgA/IgM: from day 5 after symptom onset, optimal days 14–21; IgG: from day 14 after symptom onset up to 6 weeks
Result turnaround time Same day or up to a week (depending on location); point‐of‐care option available (within 1–2 hours) Rapid, point‐of‐care (within 15 minutes) Same day or up to 1–3 days (depending on location); point‐of‐care option available (within 15–30 minutes)

CIA = chemiluminescent immunoassay; CRISPR = clustered regularly interspaced short palindromic repeats; ELISA = enzyme‐linked immunosorbent assay; FDA = US Food and Drug Administration; Ig = immunoglobulin; LAMP = loop‐mediated isothermal amplification; RT‐PCR = real‐time reverse transcriptase polymerase chain reaction; SARS‐CoV‐2 = severe acute respiratory syndrome‐coronavirus 2.