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. 2020 Nov 5;10(11):905. doi: 10.3390/diagnostics10110905

Table 3.

Summary of most recent Emergency Use Authorization (EUA) issued antigen tests for SARS-CoV-2. All the information is collected from the Food, Drug and Administration (FDA) website.

Organization Test Name Test Result Time Specimen Type LOD Characteristics
Access Bio, Inc. CareStart COVID-19 Antigen test 10 min Direct Nasopharyngeal Swab 8 × 102 TCID50/mL SARS-CoV-2 Nucleocapsid Protein-Specific, Lateral Flow, Visual Readout, Lab-based, Point-of-Care Testing (POC) but requires a sample preparation step and a trained operator to perform the test.
Quidel Corporation Sofia 2 Flu + SARS Antigen FIA 15 min Direct Nasal or Nasopharyngeal Swabs 4.17 × 105 TCID50/mL Mulitiplex Detection (SARS-CoV-2, Influenza A Virus, and Influenza B Virus), Nucleocapsid Protein-Specific, SARS-CoV, and SARS-CoV-2 Detection but cannot differentiate between them, Lateral Flow, Instrument-based Immunofluorescence Read, Lab-based, POC Testing but is limited to Sofia 2 Instrument for results, Trained Operator required.
Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag Card 15 min Direct Nasal Swab 22.5 TCID50/swab Singleplex SARS-CoV-2 Detection, No Specific to SARS-CoV-2 Detection alone (SARS-CoV Cross-reaction), Nucleocapsid Protein-Specific, Lateral Flow Immunoassay, Visual Colorimetric Pink/Purple Read but results interpretation is limited to individuals with color-impaired vision, POCT Testing but testing performance is limited by following meticulous testing instructions.
Lumira Dx UK Ltd. Lumira Dx SARS-CoV-2 Ag Test 12 min Direct Nasal Swab 32 TCID50/mL Single-Use Microfluidic Fluorescence Immunoassay, SARS-CoV-2 Nucleocapsid Protein-Specific, Digital Instrument Read, Small Sample Testing Volume (one drop), POC Testing but limited to Healthcare Professional-Use-Only proficient in performing tests using the Lumira Dx Platform, Requires Lumira Dx Test Strip.
Becton, Dickinson, and Company (BD) BD Veritor System for Rapid SARS-CoV-2 Detection 15 min Direct Nasal Swab 1.4 × 102 TCID50/mL Chromatographic Immunoassay, SARS-CoV-2 Nucleocapsid Antigen-Specific, Digital Instrument Reading, Result Documentation Capabilities, Good Analytical Sensitivity, Laboratory-based, POC Testing but is limited to patient testing environments where test interpretation can only be done with the BD Veritor Plus Analyzer Instrument.
Quidel Corporation Sofia SARS Antigen FIA 16 min Direct Nasal or Nasopharyngeal Swabs 1.13 × 102 TCID50/mL Immunofluorescent Sandwich Assay, Lateral Flow, Singleplex Detection, SARS-CoV or SARS-CoV-2 Nucleocapsid Antigen-Specific but does not differentiate between them, Instrument Reading, Good Analytical Sensitivity, Results Affected by High Viscous Samples, Result interpretation limited to trained clinical laboratory personnel proficient in performing tests using Sofia and Sofia 2 instruments.