Table 4 Rapid POC Tests Performed in Geographically Mobile and Pop-up Laboratories
Ranked by Analysis Time (min) FDA Status Hyperlink | Instrument, Manufacturer, Website Method, Test Type, Swab, Read | Specimen | Storage Temperature (°C) Testing Temperature (°C) | Sensitivity (%) Specificity (%) |
|---|---|---|---|---|
10 FDA EUA | CareStart COVID-19 Antigen Test Access Bio, Inc https://accessbiodiagnostics.net/carestart-covid-19-antigen/ Lateral Flow Assay, Antigen Test, Polyester Spun Nasal Swab, Visually Read | Anterior Nasal Swab/Nasopharyngeal Swab | 1 ~ 30/15–30 | 87.18, 100 (AN); 93.75, 99.32 (NP) |
 < 15 FDA CLEARED https://www.cdc.gov/flu/professionals/diagnosis/table-ridt.html\ | McKesson Consult Influenza A & B Test McKesson Medical-Surgical Inc https://mms.mckesson.com/product/1076728/McKesson-Brand-181-36025 Antigen Test, Nylon Flocked Swab, Visually Read | Nasal Swab Nasopharyngeal Swab | 2–30 /18–30 | Flu A (NS): 91.7, 75.2 Flu B (NS): 82.4, 88.3; Flu A (NP): 89.6, 77 Flu B (NP): 86.8, 92.9 |
 < 15 FDA EUA | Assure COVID-19 IgG/IgM Rapid Test Assure Tech (Hangzhou Co., Ltd) Lateral Flow Chromatographic Immunoassay, Antibody Test, N/A, Visually Read | Whole Blood Serum, Plasma | 2 ~ 30/15–30 | 88.7, 93.3 |
15 FDA EUA | Quidel Sofia SARS Antigen Fluorescent Immunoassay Quidel Corporation https://www.quidel.com/immunoassays/rapid-sars-tests/sofia-sars-antigen-fia Immunofluorescence-based Lateral Flow Assay, Antigen Test, Foam Tipped Swab, Instrument Read | Nasal Swab | 15–35 | 96.7, 100 |
15 FDA EUA | Quidel Sofia 2 Flu + SARS Antigen Combo Fluorescent Immunoassay Quidel Corporation https://www.quidel.com/immunoassays/sofia-2-flu-sars-antigen-fia Immunofluorescence-based Lateral Flow Assay Antigen Test Foam Tipped Swab Instrument Read | Nasal Swab, Nasopharyngeal Swab | 15–35 | Flu A (NS): 90, 95 Flu A(NP): 97.1, 94.6 Flu B (NS): 89, 96 Flu B (NP)—90, 97 SARS-CoV-2: 95.2, 100 |
20 FDA EUA | INDICAID COVID-19 Rapid Antigen Test PHASE Scientific International Ltd Lateral Flow Immunoassay, Antigen Test, Nylon Flocked Swabs, Visually Read | Nasal and Nasopharyngeal Swab | 2–30/15–30 | 84.4,96.3 |
 < 30 FDA EUA | Accula SARS-CoV-2 Test Mesa Biotech, Inc Reverse-Transcription Polymerase Chain Reaction & Lateral Flow Immunoassay Rapid RT-PCR, Cotton Tipped Swab, Visually Read | Nasal Swab, Nasal Mid-turbinate Swab | 15–30/15–30 | 95.8, 100 |
 < 30 FDA EUA | ID NOW COVID-19 Abbott Diagnostics Scarborough, Inc https://www.abbott.com/IDNOW.html Isothermal Nucleic Acid Amplification Technology Molecular NAAT Test, Foam tipped swabs, Machine Read | Nasal Swab, Nasopharyngeal or Throat Swabs | 2–30/15- 30 | 95.0, 97.9 |
30 FDA EUA | Clip COVID-19 Rapid Antigen Test Luminostics, Inc Lateral Flow Immunoluminescent Assay Antigen Test, Cotton-tipped Swab, Machine Read | Anterior Nasal Swab | 15- 30/15- 30 | 96.9, 100 |
 > 24 hoursa https://www.accessdata.fda.gov/cdrh_docs/pdf20/DEN200031.pdf | BioFire Respiratory Panel 2.1 BioMérieux, Inc https://www.biofiredx.com/products/the-filmarray-panels/filmarrayrp/ PCR-based multiplex Nucleic Acid Amplification Technology, Molecular NAAT test, Nylon Flocked Swab, Machine Read | Nasopharyngeal Swab | 15–25 (4 h), 2–8 (3 days), ≤ -15 ≤ -70 (30 days)/15–25 | 97.1, 99.3 |