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 |
a) BioFire has an analysis time of 45 min. However, the specimen collected is shipped overnight to a third-party laboratory to be processed on a BioFire® FilmArray 2.0 system
CE Conformité Européenne, CLIA Clinical Laboratory Improvement Amendments, COVID-19 Coronavirus disease 2019, EUA Emergency Use Authorization, FDA United States Food and Drug Administration, IgG immunoglobulin G, IgM immunoglobulin M, NAAT nucleic acid amplification test, NP nasopharyngeal, NS nasal swab, PCR polymerase chain reaction; and SARS-CoV-2 severe acute respiratory syndrome Coronavirus 2