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Table 1. CLIA-waived COVID-19-related in vitro molecular diagnostic tests (e.g., RT-PCR, LAMP, isothermal amplification) receiving U.S. FDA Emergency Use Authorizations (EUAs) First date EUA issued Manufacturer Name of test or assay Required instrument Technology (Method) Multi-analyte? RADx-funded? Approved for at-home? Additional comments 20 March 2020 Cepheid Xpert Xpress SARS-CoV-2 test GeneXpert Xpress System (Tablet and Hub Configurations) Molecular (RT-PCR) No No No Has largely received positive review of sensitivity and specificity. 23 March 2020 Mesa Biotech Inc. Accula SARS-CoV-2 test Accula Dock or the Sekisui Diagnostics Silaris Dock (discontinued) Molecular (RT-PCR) No Yes No Has received only minor scrutiny, with only several dozen FDA complaints/reports 27 March 2020 Abbott Diagnostics Scarborough, Inc. ID NOW COVID-19 ID NOW Molecular (isothermal amplification) No No No Targets "a unique region of the RNA-dependent RNA polymerase (RdRP) gene."Device and test were target of FDA scrutiny due to sensitivity issues reported in 2020 and into 2021 In October 2020, Abbott released additional study data showing overall sensitivity of 93.3% and specificity of 98.4%, emphasizing the ID NOW's best use with samples taken within seven days of symptom onset. In 2020, some 393 complaints were reported to the FDA, with 1,492 complains being reported in 2021 (through July 31) according to an FDA MAUDE (Manufacturer and User Facility Device Experience) search. On August 27, 2021, the FDA re-issued its EUA for the ID NOW with updated in silico inclusivity analysis results (among other things), but it's not clear if the FDA is continuing to work with Abbott on the test's accuracy claims. 10 June 2020 Cue Health Inc. Cue COVID-19 Test Cartridge Cue Health Monitoring System Molecular (isothermal amplification) No No No "Test primers amplify the nucleocapsid (N) region of the gene" 14 September 2020 Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B Assay cobas Liat PCR System Molecular (RT-PCR) Yes No No Everitt et al. offer some discussion and citations concerning research related to the cobas LIAT PCR system and its assays. 24 September 2020 Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV test GeneXpert Xpress System (Tablet and Hub Configurations) Molecular (RT-PCR) Yes No No Development of this multiplex assay for SARS-CoV-2, Flu A, Flu B, and RSV was announced in June 2020. After receiving its EUA in September 2020, received advanced development support through the Department of Health and Human Services and the Department of Defense. 02 October 2020 BioFire Diagnostics, LLC BioFire Respiratory 2.1 (RP2.1) Panel BioFire FilmArray Systems Molecular (RT-PCR) Yes No No From the manufacturer: "The BioFire RP2.1 Panel (EUA) detects 22 respiratory pathogens, including SARS-CoV-2, to help clinicians quickly rule in and rule out common causes of respiratory illness in about 45 minutes." Creager et al. reported their evaluation findings in the Journal of Clinical Virology, stating that the panel "has similar performance to high throughput assays used for the detection of COVID-19." 17 November 2020 Lucira Health, Inc. Lucira COVID-19 All-In-One Test Kit N/A Molecular (RT-LAMP) No No Yes First complete at-home COVID test kit receiving EUA. For CLIA-waived labs and prescription at-home use. Test device is apparently one-time-use and not reusable. 27 November 2020 Cepheid Xpert Omni SARS-CoV-2 test GeneXpert Omni System Molecular (RT-PCR) No No No For CLIA-waived testing, the test is limited to nasopharyngeal, anterior nasal, or mid-turbinate swab specimens. Product status unclear, as it was listed on website in January 2021, but not listed there as of September 2021. 08 February 2021 Visby Medical, Inc. Visby Medical COVID-19 Point of Care Test N/A Molecular (RT-PCR) No Yes No "By shrinking rapid PCR technology to palm-sized dimensions and eliminating the need for an additional instrument or reader, Visby Medical’s test provides fast, accurate, and actionable results at the point of need." 05 March 2021 Cue Health Inc. Cue COVID-19 Test for Home and Over The Counter Use Cue Health Monitoring System Molecular (isothermal amplification) No No Yes Described as "the nation’s first molecular diagnostic test available without a prescription to consumers for home use and to enterprise users and healthcare professionals without CLIA certification." It is also able to be used for screening purposes. 09 April 2021 Lucira Health, Inc. Lucira CHECK-IT COVID-19 Test Kit N/A Molecular (RT-LAMP) No No Yes Appears to be an over-the-counter (vs. prescription) version of its Lucira COVID-19 All-In-One Test Kit from November 2020. Also able to be used for screening. 17 June 2021 Roche Molecular Systems, Inc. cobas SARS-CoV-2 Assay cobas Liat PCR System Molecular (RT-PCR) No No No Appears to be similar to its multi-analyte product from 2020 but solely for COVID-19, and also able to be used for screening. N/A (Anticipated) Talis Biomedical Talis One Cartridge Talis One Instrument Molecular (RT-LAMP) No Yes To be determined Expectations are that it will receive an FDA EUA and be CLIA-waived, but yet to be determined. As of August 2021, it was still awaiting FDA authorization.

Table 2. CLIA-waived COVID-19-related in vitro antigen diagnostic tests (e.g., lateral flow, immunoassay, etc.) receiving U.S. FDA Emergency Use Authorizations (EUAs) First date EUA issued Manufacturer Name of test or assay Required instrument Technology (Method) Multi-analyte? RADx-funded? Approved for at-home? Additional comments 08 May 2020 Quidel Corporation Sofia SARS Antigen FIA Sofia 2 Antigen (Lateral flow) No Yes No SARS-CoV-2 Sensitivity (PPA): 96.7%; SARS-CoV-2 Specificity (NPA): 100% 02 July 2020 Becton, Dickinson and Company BD Veritor System for Rapid Detection of SARS-CoV-2 BD Veritor Plus Antigen (Immunoassay) No No No SARS-CoV-2 Sensitivity (PPA): 84%; SARS-CoV-2 Specificity (NPA): 100% 18 August 2020 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 Ag Test LumiraDx Platform Antigen (Microfluidic) No No No SARS-CoV-2 Sensitivity (PPA): 97.6%; SARS-CoV-2 Specificity (NPA): 96.6%. As of September 2021, at least one performance evaluation study is in-process. 26 August 2020 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag Card NAVICA mobile system Antigen (Lateral flow) No No No SARS-CoV-2 Sensitivity (PPA): 84.6%; SARS-CoV-2 Specificity (NPA): 98.5% 02 October 2020 Quidel Corporation Sofia 2 Flu + SARS Antigen FIA Sofia 2 Antigen (Lateral flow) Yes Yes No SARS-CoV-2 Sensitivity (PPA): 95.2%; SARS-CoV-2 Specificity (NPA): 100% 08 October 2020 Access Bio, Inc. CareStart COVID-19 Antigen N/A Antigen (Lateral flow) No No No SARS-CoV-2 Sensitivity (PPA): 90.47%; SARS-CoV-2 Specificity (NPA): 99.66% (Note: average of swab types) 07 December 2020 Luminostics, Inc. Clip COVID Rapid Antigen Test Clip Analyzer (PDF) Antigen (Lateral flow) No Yes No SARS-CoV-2 Sensitivity (PPA): 96.9%; SARS-CoV-2 Specificity (NPA): 100% 18 December 2020 Quidel Corporation QuickVue SARS Antigen Test N/A Antigen (Lateral flow) No No No SARS-CoV-2 Sensitivity (PPA): 96.6%; SARS-CoV-2 Specificity (NPA): 99.3% 04 February 2021 Princeton BioMeditech Corp. Status COVID-19/Flu A&B N/A Antigen (Lateral flow) Yes No No SARS-CoV-2 Sensitivity (PPA): 93.9%; SARS-CoV-2 Specificity (NPA): 100%