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| | style="background-color:white; padding-left:10px; padding-right:10px;" colspan="9"|'''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)
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| ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|First date EUA issued
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| ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Manufacturer
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| ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Name of test or assay
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| ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Required instrument
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| ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Technology (Method)
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| ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Multi-analyte?
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| ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|RADx-funded?
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| ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Approved for at-home?
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| ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Additional comments
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|20 March 2020
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Cepheid
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.cepheid.com/coronavirus Xpert Xpress SARS-CoV-2 test]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.cepheid.com/en_US/systems/GeneXpert-Family-of-Systems/GeneXpert-Xpress GeneXpert Xpress System (Tablet and Hub Configurations)]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Molecular (RT-PCR)
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Has largely received positive review of sensitivity and specificity.<ref name="MoranDetect20">{{cite journal |title=Detection of SARS-CoV-2 by Use of the Cepheid Xpert Xpress SARS-CoV-2 and Roche cobas SARS-CoV-2 Assays |journal=Journal of Clinical Microbiology |author=Moran, A.; Beavis, K.G.; Matushek, S.M. et al. |volume=58 |issue=8 |at=e00772-20 |year=2020 |doi=10.1128/JCM.01072-20 |pmid=32303565 |pmc=PMC7383516}}</ref><ref name="LoeffelholzMulti20">{{cite journal |title=Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test |journal=Journal of Clinical Microbiology |author=Loeffelholz, M.J.; Alland, D.; Butler-Wu, S.M. et al. |volume=58 |issue=8 |at=e00926-20 |year=2020 |doi=10.1128/JCM.00926-20 |pmid=32366669 |pmc=PMC7383535}}</ref><ref name="GoldenbergerBrief20">{{cite journal |title=Brief validation of the novel GeneXpert Xpress SARS-CoV-2 PCR assay |journal=Journal of Virological Methods |author=Goldenberger, D.; Leusinger, K.; Sogaard, K.K. et al. |volume=284 |at=113925 |year=2020 |doi=10.1016/j.jviromet.2020.113925 |pmid=32659240 |pmc=PMC7351036}}</ref>
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|23 March 2020
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Mesa Biotech Inc.
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.mesabiotech.com/#featured-sarscov-section Accula SARS-CoV-2 test]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.mesabiotech.com/#products-section Accula Dock] or the Sekisui Diagnostics Silaris Dock (discontinued)
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Molecular (RT-PCR)
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Yes
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Has received only minor scrutiny<ref name="HoganComp20">{{cite journal |title=Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens |journal=Journal of Clinical Microbiology |author=Hogan, C.A.; Garamani, N.; Lee, A.S. et al. |volume=58 |issue=8 |at=e01072-20 |year=2020 |doi=10.1128/JCM.01072-20 |pmid=32461285 |pmc=PMC7383558}}</ref>, with only several dozen FDA complaints/reports<ref name="FDAMAUDE1">{{cite web |url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm |title=MAUDE - Manufacturer and User Facility Device Experience |publisher=U.S. Food and Drug Administration |accessdate=08 September 2021 |quote=Search for "Accula" in Brand Name}}</ref>
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|27 March 2020
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Abbott Diagnostics Scarborough, Inc.
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.globalpointofcare.abbott/en/product-details/id-now-covid-19.html ID NOW COVID-19]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.globalpointofcare.abbott/en/product-details/id-now.html ID NOW]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Molecular (isothermal amplification)
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Targets "a unique region of the RNA-dependent RNA polymerase (RdRP) gene."<ref name="RaviDiag20">{{cite journal |title=Diagnostics for SARS-CoV-2 detection: A comprehensive review of the FDA-EUA COVID-19 testing landscape |journal=Biosensors and Bioelectronics |author=Ravi, N.; Cortade, D.L.; Ng, E. et al. |volume=165 |at=112454 |year=2020 |doi=10.1016/j.bios.2020.112454 |pmid=32729549 |pmc=PMC7368663}}</ref>Device and test were target of FDA scrutiny due to sensitivity issues reported in 2020 and into 2021<ref name="DevineCorona20">{{cite web |url=https://www.cnn.com/2020/07/03/politics/coronavirus-white-house-test-abbott/index.html |title=Coronavirus test used by White House has questionable accuracy |author=Devine, C. |work=CNN Politics |date=03 July 2020 |accessdate=08 July 2020}}</ref><ref name="PerroneFDA20">{{cite web |url=https://apnews.com/c8ab010e8e02dfe7beb34a5e5df11279 |title=FDA probes accuracy issue with Abbott’s rapid virus test |author=Perrone, M. |work=Associated Press |date=14 May 2020 |accessdate=19 May 2020}}</ref><ref name="BasuPerform20">{{cite journal |title=Performance of Abbott ID Now COVID-19 Rapid Nucleic Acid Amplification Test Using Nasopharyngeal Swabs Transported in Viral Transport Media and Dry Nasal Swabs in a New York City Academic Institution |journal=Journal of Clinical Microbiology |author=Basu, A.; Zinger, T.; Inglima, K. et al. |volume=58 |issue=8 |at=e01136-20 |year=2020 |doi=10.1128/JCM.01136-20 |pmid=32471894 |pmc=PMC7383552}}</ref><ref name="MitchellEval20">{{cite journal |title=Evaluation of the COVID19 ID NOW EUA assay |journal=Journal of Clinical Virology |author=Mitchell, S.L.; St. George, K. |volume=128 |at=104429 |year=2020 |doi=10.1016/j.jcv.2020.104429 |pmid=32425657 |pmc=PMC7227587}}</ref> 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.<ref name="TaylorAbbot20">{{cite web |url=https://www.medtechdive.com/news/abbott-on-defense-id-now-coronavirus-test-postmarket-study/586579/ |title=Abbott, on defense, details embattled rapid COVID-19 test results |author=Taylor, N.P. |work=MedTechDive |date=07 October 2020 |accessdate=18 November 2020}}</ref> 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.<ref name="FDAMAUDE2">{{cite web |url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm |title=MAUDE - Manufacturer and User Facility Device Experience |publisher=U.S. Food and Drug Administration |accessdate=07 September 2021 |quote=Search for "ID NOW COVID-19" in Brand Name}}</ref> On August 27, 2021, the FDA re-issued its EUA for the ID NOW with updated ''in silico'' inclusivity analysis results (among other things)<ref name="HintonIDNOWAug21">{{cite web |url=https://www.fda.gov/media/136522/download |format=PDF |title=ID NOW COVID-19 |author=Hinton, D.M. |publisher=U.S. Food and Drug Administration |date=27 August 2021 |accessdate=07 September 2021}}</ref>, but it's not clear if the FDA is continuing to work with Abbott on the test's accuracy claims.
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|10 June 2020
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Cue Health Inc.
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.cuehealth.com/products/how-cue-detects-covid-19/ Cue COVID-19 Test Cartridge]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.cuehealth.com/products/how-cue-detects-covid-19/ Cue Health Monitoring System]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Molecular (isothermal amplification)
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|"Test primers amplify the nucleocapsid (N) region of the gene"<ref name="CueCOVID19Inst">{{cite web |url=https://www.fda.gov/media/138826/download |format=PDF |title=Cue COVID-19 Test Instructions for Use |publisher=Cue Health, Inc |date=26 March 2021 |accessdate=08 September 2021}}</ref>
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|14 September 2020
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Roche Molecular Systems, Inc.
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://diagnostics.roche.com/us/en/products/params/cobas-sars-cov-2-influenza-a-b-nucleic-acid-test.html cobas SARS-CoV-2 & Influenza A/B Assay]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://diagnostics.roche.com/global/en/products/instruments/cobas-liat.html cobas Liat PCR System]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Molecular (RT-PCR)
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Yes
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Everitt ''et al.'' offer some discussion and citations concerning research related to the cobas LIAT PCR system and its assays.<ref name="EverittACritical20">{{cite journal |title=A critical review of point-of-care diagnostic technologies to combat viral pandemics |journal=Analytica Chimica Acta |author=Everitt, M.L.; Tillery, A.; David, M.G. et al. |volume=In Press |year=2020 |doi=10.1016/j.aca.2020.10.009 |pmc=PMC7548029}}</ref>
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|24 September 2020
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Cepheid
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.cepheid.com/coronavirus Xpert Xpress SARS-CoV-2/Flu/RSV test]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.cepheid.com/en_US/systems/GeneXpert-Family-of-Systems/GeneXpert-Xpress GeneXpert Xpress System (Tablet and Hub Configurations)]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Molecular (RT-PCR)
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Yes
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Development of this multiplex assay for SARS-CoV-2, Flu A, Flu B, and RSV was announced in June 2020.<ref name="PRNCepheidAnn20">{{cite web |url=https://www.prnewswire.com/news-releases/cepheid-announces-development-of-four-in-one-combination-test-for-sars-cov-2-flu-a-flu-b-and-rsv-301072489.html |title=Cepheid Announces Development of Four-in-One Combination Test for SARS-CoV-2, Flu A, Flu B and RSV |author=Cepheid |work=PR Newswire |date=09 June 2020 |accessdate=13 August 2020}}</ref> After receiving its EUA in September 2020, received advanced development support through the Department of Health and Human Services and the Department of Defense.<ref name="GBS_BARDA20">{{cite web |url=https://globalbiodefense.com/2020/10/08/barda-and-jpeo-cbrnd-back-cepheids-multiplex-test-for-flu-rsv-and-sars-cov2/ |title=BARDA and JPEO-CBRND Back Cepheid’s Multiplex Test for Influenza, SARS-CoV2 and RSV |author=Global Biodefense Staff |work=Global Biodefense |date=08 October 2020 |accessdate=19 November 2020}}</ref>
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|02 October 2020
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|BioFire Diagnostics, LLC
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.biofiredx.com/covid-19/ BioFire Respiratory 2.1 (RP2.1) Panel]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.biofiredx.com/products/filmarray/ BioFire FilmArray Systems]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Molecular (RT-PCR)
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Yes
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|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."<ref name="BioFireResp20">{{cite web |url=https://www.biofiredx.com/covid-19/ |title=BioFire’s Respiratory Solutions
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| with SARS-CoV-2 |publisher=BioFire Diagnostics, LLC |accessdate=19 November 2020}}</ref> 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."<ref name="CreagerClinical20">{{cite journal |title=Clinical evaluation of the BioFire Respiratory Panel 2.1 and detection of SARS-CoV-2 |journal=Journal of Clinical Virology |author=Creager, H.M.; Cabrera, B.; Schnaubelt, A. et al. |volume=129 |at=104538 |year=2020 |doi=10.1016/j.jcv.2020.104538 |pmid=32650276 |pmc=PMC7336953}}</ref>
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|17 November 2020
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Lucira Health, Inc.
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.lucirahealth.com/ Lucira COVID-19 All-In-One Test Kit]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|N/A
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Molecular (RT-LAMP)
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Yes
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|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.<ref name="FDALuciraIFU20">{{cite web |url=https://www.fda.gov/media/143809/download |title=Lucira Health COVID-19 All-In-One Test Kit |publisher=Lucira Health, Inc |date=2020 |accessdate=20 November 2020}}</ref>
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|27 November 2020
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Cepheid
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://cepheid.widen.net/s/wt962cbqtf Xpert Omni SARS-CoV-2 test]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://cepheid.widen.net/s/wt962cbqtf GeneXpert Omni System]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Molecular (RT-PCR)
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|For CLIA-waived testing, the test is limited to nasopharyngeal, anterior nasal, or mid-turbinate swab specimens.<ref name="CepheidXpertOmni21">{{cite web |url=https://www.fda.gov/media/144033/download |format=PDF |title=Xpert Omni SARS-CoV-2 |publisher=Cepheid |date=April 2021 |accessdate=08 September 2021}}</ref> Product status unclear, as it was listed on website in January 2021<ref name="GeneXpertOmniArch">{{cite web |url=https://www.cepheid.com/en_US/systems/GeneXpert-Family-of-Systems/GeneXpert-Omni |archiveurl=https://web.archive.org/web/20210123173157/https://www.cepheid.com/en_US/systems/GeneXpert-Family-of-Systems/GeneXpert-Omni |title=Introducing the GeneXpert Omni |publisher=Cepheid |archivedate=23 January 2021 |accessdate=08 September 2021}}</ref>, but not listed there as of September 2021.
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|08 February 2021
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Visby Medical, Inc.
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.visbymedical.com/covid-19-test/ Visby Medical COVID-19 Point of Care Test]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|N/A
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Molecular (RT-PCR)
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Yes
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|"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."<ref name="VisbyMed21">{{cite web |url=https://www.visbymedical.com/news/press-release-visby-medical-covid-19-pcr-point-of-care-test-authorized-for-use-in-clia-waived-settings |title=Visby Medical’s COVID-19 PCR Point of Care Test Authorized for Use in CLIA Waived Settings |publisher=Visby Medical, Inc |date=02 February 2021 |accessdate=08 September 2021}}</ref>
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|05 March 2021
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Cue Health Inc.
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.cuehealth.com/products/how-cue-detects-covid-19/ Cue COVID-19 Test for Home and Over The Counter Use]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.cuehealth.com/products/how-cue-detects-covid-19/ Cue Health Monitoring System]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Molecular (isothermal amplification)
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Yes
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|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."<ref name="CueCovid">{{cite web |url=https://www.cuehealth.com/products/how-cue-detects-covid-19/ |title=Cue’s COVID‑19 Diagnostic Test |publisher=Cue Health, Inc |accessdate=08 September 2021}}</ref> It is also able to be used for screening purposes.
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|09 April 2021
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Lucira Health, Inc.
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.lucirahealth.com/ Lucira CHECK-IT COVID-19 Test Kit]
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|N/A
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Molecular (RT-LAMP)
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Yes
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|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.
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|17 June 2021
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| | style="background-color:white; padding-left:10px; padding-right:10px;"|Roche Molecular Systems, Inc.
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://diagnostics.roche.com/us/en/products/params/cobas-sars-cov-2-test.html cobas SARS-CoV-2 Assay]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://diagnostics.roche.com/global/en/products/instruments/cobas-liat.html cobas Liat PCR System]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Molecular (RT-PCR)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Appears to be similar to its multi-analyte product from 2020 but solely for COVID-19, and also able to be used for screening.<ref name="RocheCobas20">{{cite web |url=https://www.fda.gov/media/150278/download |title=cobas SARS-CoV-2 |publisher=Roche Molecular Systems, Inc |date=December 2020 |accessdate=08 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|N/A (Anticipated)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Talis Biomedical
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://talisbio.com/talis-one-covid-19-assay/ Talis One Cartridge]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://talisbio.com/talis-one-point-of-care-instrument/ Talis One Instrument]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Molecular (RT-LAMP)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Yes
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|To be determined
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Expectations are that it will receive an FDA EUA and be CLIA-waived<ref name="TalisOne">{{cite web |url=https://talisbio.com/talis-one-covid-19-assay/ |title=Talis One Molecular Testing |publisher=Talis Biomedical |accessdate=08 September 2021}}</ref>, but yet to be determined. As of August 2021, it was still awaiting FDA authorization.<ref name="O'ConnorDespite21">{{cite web |url=https://www.360dx.com/business-news/despite-mdx-product-delays-talis-biomedical-expecting-meaningful-revenue-ramp-2022 |archiveurl=https://web.archive.org/web/20210811210316/https://www.360dx.com/business-news/despite-mdx-product-delays-talis-biomedical-expecting-meaningful-revenue-ramp-2022 |title=Despite MDx Product Delays, Talis Biomedical Expecting 'Meaningful Revenue Ramp in 2022' |author=O'Connor, L. |work=360 Dx |date=11 August 2021 |archivedate=11 August 2021 |accessdate=07 September 2021}}</ref>
| |
| |-
| |
| |}
| |
| |}
| |
|
| |
| {|
| |
| | STYLE="vertical-align:top;"|
| |
| {| class="wikitable" border="1" cellpadding="5" cellspacing="0" width="80%"
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| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;" colspan="9"|'''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)
| |
| |-
| |
| ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|First date EUA issued
| |
| ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Manufacturer
| |
| ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Name of test or assay
| |
| ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Required instrument
| |
| ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Technology (Method)
| |
| ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Multi-analyte?
| |
| ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|RADx-funded?
| |
| ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Approved for at-home?
| |
| ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Additional comments
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|08 May 2020
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Quidel Corporation
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.quidel.com/immunoassays/rapid-sars-tests/sofia-sars-antigen-fia Sofia SARS Antigen FIA]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.quidel.com/immunoassays/sofia-tests-kits/sofia-2-analyzer Sofia 2]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Antigen (Lateral flow)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Yes
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|SARS-CoV-2 Sensitivity (PPA): 96.7%; SARS-CoV-2 Specificity (NPA): 100%<ref name="QuidelSofiaSARS">{{cite web |url=https://www.quidel.com/immunoassays/rapid-sars-tests/sofia-sars-antigen-fia |title=Sofia SARS Antigen FIA |publisher=Quidel Corporation |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|02 July 2020
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Becton, Dickinson and Company
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://bdveritor.bd.com/en-us/rapid-antigen-testing/covid-19 BD Veritor System for Rapid Detection of SARS-CoV-2]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://bdveritor.bd.com/en-us/bd-veritor-plus-system BD Veritor Plus]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Antigen (Immunoassay)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|SARS-CoV-2 Sensitivity (PPA): 84%; SARS-CoV-2 Specificity (NPA): 100%<ref name="BDVeritor21" />
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|18 August 2020
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|LumiraDx UK Ltd.
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.lumiradx.com/us-en/what-we-do/diagnostics/test-technology/antigen-test LumiraDx SARS-CoV-2 Ag Test]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.lumiradx.com/us-en/what-we-do/diagnostics/platform-technology LumiraDx Platform]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Antigen (Microfluidic)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|SARS-CoV-2 Sensitivity (PPA): 97.6%; SARS-CoV-2 Specificity (NPA): 96.6%.<ref name="LimiraDxCOVIDAntigen">{{cite web |url=https://www.lumiradx.com/us-en/what-we-do/diagnostics/test-technology/antigen-test |title=COVID-19 SARS-CoV-2 Antigen Test |publisher=LumiraDx UK Ltd |accessdate=09 September 2021}}</ref> As of September 2021, at least one performance evaluation study is in-process.<ref name="NIHPerformance20">{{cite web |url=https://clinicaltrials.gov/ct2/show/NCT04557046 |title=Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag Test (ASPIRE) |work=ClinicalTrials.gov |publisher=National Institutes of Health |date=22 October 2020}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|26 August 2020
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Abbott Diagnostics Scarborough, Inc.
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.globalpointofcare.abbott/en/product-details/binaxnow-covid-19-home-test-us.html BinaxNOW COVID-19 Ag Card]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.globalpointofcare.abbott/en/product-details/navica.html NAVICA mobile system]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Antigen (Lateral flow)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|SARS-CoV-2 Sensitivity (PPA): 84.6%; SARS-CoV-2 Specificity (NPA): 98.5%<ref name="AbbottBinaxNOW20">{{cite web |url=https://www.fda.gov/media/141570/download |format=PDF |title=BinaxNOW COVID-19 Ag CARD |publisher=Abbott Diagnostics Scarborough, Inc |date=December 2020 |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|02 October 2020
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Quidel Corporation
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.quidel.com/immunoassays/sofia-2-flu-sars-antigen-fia Sofia 2 Flu + SARS Antigen FIA]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.quidel.com/immunoassays/sofia-tests-kits/sofia-2-analyzer Sofia 2]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Antigen (Lateral flow)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Yes
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Yes
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|SARS-CoV-2 Sensitivity (PPA): 95.2%; SARS-CoV-2 Specificity (NPA): 100%<ref name="QuidelSofiaSARSFlu">{{cite web |url=https://www.quidel.com/immunoassays/sofia-2-flu-sars-antigen-fia |title=Sofia 2 Flu + SARS Antigen FIA |publisher=Quidel Corporation |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|08 October 2020
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Access Bio, Inc.
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://accessbiodiagnostics.net/carestart-covid-19-antigen/ CareStart COVID-19 Antigen]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|N/A
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Antigen (Lateral flow)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|SARS-CoV-2 Sensitivity (PPA): 90.47%; SARS-CoV-2 Specificity (NPA): 99.66% (Note: average of swab types)<ref name="AccessBioCOVID19Antigen">{{cite web |url=https://accessbiodiagnostics.net/carestart-covid-19-antigen/ |title=CareStart COVID-19 Antigen |publisher=Access Bio, Inc |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|07 December 2020
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Luminostics, Inc.
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://luminostics.com/ Clip COVID Rapid Antigen Test]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://lib.umso.co/lib_XCpfHrGtBDMqBGId/05k9nl44ty7t61sj.pdf Clip Analyzer] (PDF)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Antigen (Lateral flow)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Yes
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|SARS-CoV-2 Sensitivity (PPA): 96.9%; SARS-CoV-2 Specificity (NPA): 100%<ref name="LuminosticsClip21">{{cite web |url=https://lib.umso.co/lib_XCpfHrGtBDMqBGId/rphccfc1jrh5j5yz.pdf |format=PDF |title=Clip COVID Rapid Antigen Test |publisher=Luminostics, Inc |date=2021 |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|18 December 2020
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Quidel Corporation
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.quidel.com/immunoassays/quickvue-sars-antigen-test QuickVue SARS Antigen Test]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|N/A
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Antigen (Lateral flow)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|SARS-CoV-2 Sensitivity (PPA): 96.6%; SARS-CoV-2 Specificity (NPA): 99.3%<ref name="QuidelQuickVue">{{cite web |url=https://www.quidel.com/immunoassays/quickvue-sars-antigen-test |title= QuickVue SARS Antigen Test |publisher=Quidel Corporation |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|04 February 2021
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Princeton BioMeditech Corp.
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[http://www.pbmc.com/products/covid.shtm Status COVID-19/Flu A&B]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|N/A
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Antigen (Lateral flow)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Yes
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|SARS-CoV-2 Sensitivity (PPA): 93.9%; SARS-CoV-2 Specificity (NPA): 100%<ref name="PrincetonStatus">{{cite web |url=http://www.pbmc.com/products/covid.shtm |title=Status COVID-19/Flu A&B - Rapid SARS-CoV-2/Influenza A+B Antigen Panel Test |publisher=Princeton BioMeditech Corp |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| |}
| |
| |}
| |
