User:Shawndouglas/Sandbox

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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.[1][2][3]
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[4], with only several dozen FDA complaints/reports[5]
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."[6]Device and test were target of FDA scrutiny due to sensitivity issues reported in 2020 and into 2021[7][8][9][10] 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.[11] 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.[12] On August 27, 2021, the FDA re-issued its EUA for the ID NOW with updated in silico inclusivity analysis results (among other things)[13], 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]
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.[15]
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.[16] After receiving its EUA in September 2020, received advanced development support through the Department of Health and Human Services and the Department of Defense.[17]
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."[18] 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."[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.[20]
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.[21] Product status unclear, as it was listed on website in January 2021[22], 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."[23]
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."[24] 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.[25]
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[26], but yet to be determined. As of August 2021, it was still awaiting FDA authorization.[27]
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%[28]
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%[29]
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%.[30] As of September 2021, at least one performance evaluation study is in-process.[31]
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%[32]
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%[33]
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)[34]
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%[35]
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%[36]
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%[37]
  1. ↑ Moran, A.; Beavis, K.G.; Matushek, S.M. et al. (2020). "Detection of SARS-CoV-2 by Use of the Cepheid Xpert Xpress SARS-CoV-2 and Roche cobas SARS-CoV-2 Assays". Journal of Clinical Microbiology 58 (8): e00772-20. doi:10.1128/JCM.01072-20. PMC PMC7383516. PMID 32303565. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7383516. 
  2. ↑ Loeffelholz, M.J.; Alland, D.; Butler-Wu, S.M. et al. (2020). "Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test". Journal of Clinical Microbiology 58 (8): e00926-20. doi:10.1128/JCM.00926-20. PMC PMC7383535. PMID 32366669. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7383535. 
  3. ↑ Goldenberger, D.; Leusinger, K.; Sogaard, K.K. et al. (2020). "Brief validation of the novel GeneXpert Xpress SARS-CoV-2 PCR assay". Journal of Virological Methods 284: 113925. doi:10.1016/j.jviromet.2020.113925. PMC PMC7351036. PMID 32659240. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7351036. 
  4. ↑ Hogan, C.A.; Garamani, N.; Lee, A.S. et al. (2020). "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 of Clinical Microbiology 58 (8): e01072-20. doi:10.1128/JCM.01072-20. PMC PMC7383558. PMID 32461285. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7383558. 
  5. ↑ "MAUDE - Manufacturer and User Facility Device Experience". U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm. Retrieved 08 September 2021. "Search for "Accula" in Brand Name" 
  6. ↑ Ravi, N.; Cortade, D.L.; Ng, E. et al. (2020). "Diagnostics for SARS-CoV-2 detection: A comprehensive review of the FDA-EUA COVID-19 testing landscape". Biosensors and Bioelectronics 165: 112454. doi:10.1016/j.bios.2020.112454. PMC PMC7368663. PMID 32729549. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7368663. 
  7. ↑ Devine, C. (3 July 2020). "Coronavirus test used by White House has questionable accuracy". CNN Politics. https://www.cnn.com/2020/07/03/politics/coronavirus-white-house-test-abbott/index.html. Retrieved 08 July 2020. 
  8. ↑ Perrone, M. (14 May 2020). "FDA probes accuracy issue with Abbott’s rapid virus test". Associated Press. https://apnews.com/c8ab010e8e02dfe7beb34a5e5df11279. Retrieved 19 May 2020. 
  9. ↑ Basu, A.; Zinger, T.; Inglima, K. et al. (2020). "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 of Clinical Microbiology 58 (8): e01136-20. doi:10.1128/JCM.01136-20. PMC PMC7383552. PMID 32471894. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7383552. 
  10. ↑ Mitchell, S.L.; St. George, K. (2020). "Evaluation of the COVID19 ID NOW EUA assay". Journal of Clinical Virology 128: 104429. doi:10.1016/j.jcv.2020.104429. PMC PMC7227587. PMID 32425657. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7227587. 
  11. ↑ Taylor, N.P. (7 October 2020). "Abbott, on defense, details embattled rapid COVID-19 test results". MedTechDive. https://www.medtechdive.com/news/abbott-on-defense-id-now-coronavirus-test-postmarket-study/586579/. Retrieved 18 November 2020. 
  12. ↑ "MAUDE - Manufacturer and User Facility Device Experience". U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm. Retrieved 07 September 2021. "Search for "ID NOW COVID-19" in Brand Name" 
  13. ↑ Hinton, D.M. (27 August 2021). "ID NOW COVID-19" (PDF). U.S. Food and Drug Administration. https://www.fda.gov/media/136522/download. Retrieved 07 September 2021. 
  14. ↑ "Cue COVID-19 Test Instructions for Use" (PDF). Cue Health, Inc. 26 March 2021. https://www.fda.gov/media/138826/download. Retrieved 08 September 2021. 
  15. ↑ Everitt, M.L.; Tillery, A.; David, M.G. et al. (2020). "A critical review of point-of-care diagnostic technologies to combat viral pandemics". Analytica Chimica Acta In Press. doi:10.1016/j.aca.2020.10.009. PMC PMC7548029. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7548029. 
  16. ↑ Cepheid (9 June 2020). "Cepheid Announces Development of Four-in-One Combination Test for SARS-CoV-2, Flu A, Flu B and RSV". PR Newswire. 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. Retrieved 13 August 2020. 
  17. ↑ Global Biodefense Staff (8 October 2020). "BARDA and JPEO-CBRND Back Cepheid’s Multiplex Test for Influenza, SARS-CoV2 and RSV". Global Biodefense. https://globalbiodefense.com/2020/10/08/barda-and-jpeo-cbrnd-back-cepheids-multiplex-test-for-flu-rsv-and-sars-cov2/. Retrieved 19 November 2020. 
  18. ↑ [https://www.biofiredx.com/covid-19/ "BioFire’s Respiratory Solutions with SARS-CoV-2"]. BioFire Diagnostics, LLC. https://www.biofiredx.com/covid-19/. Retrieved 19 November 2020. 
  19. ↑ Creager, H.M.; Cabrera, B.; Schnaubelt, A. et al. (2020). "Clinical evaluation of the BioFire Respiratory Panel 2.1 and detection of SARS-CoV-2". Journal of Clinical Virology 129: 104538. doi:10.1016/j.jcv.2020.104538. PMC PMC7336953. PMID 32650276. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7336953. 
  20. ↑ "Lucira Health COVID-19 All-In-One Test Kit". Lucira Health, Inc. 2020. https://www.fda.gov/media/143809/download. Retrieved 20 November 2020. 
  21. ↑ "Xpert Omni SARS-CoV-2" (PDF). Cepheid. April 2021. https://www.fda.gov/media/144033/download. Retrieved 08 September 2021. 
  22. ↑ "Introducing the GeneXpert Omni". Cepheid. Archived from the original on 23 January 2021. https://web.archive.org/web/20210123173157/https://www.cepheid.com/en_US/systems/GeneXpert-Family-of-Systems/GeneXpert-Omni. Retrieved 08 September 2021. 
  23. ↑ "Visby Medical’s COVID-19 PCR Point of Care Test Authorized for Use in CLIA Waived Settings". Visby Medical, Inc. 2 February 2021. https://www.visbymedical.com/news/press-release-visby-medical-covid-19-pcr-point-of-care-test-authorized-for-use-in-clia-waived-settings. Retrieved 08 September 2021. 
  24. ↑ "Cue’s COVID‑19 Diagnostic Test". Cue Health, Inc. https://www.cuehealth.com/products/how-cue-detects-covid-19/. Retrieved 08 September 2021. 
  25. ↑ "cobas SARS-CoV-2". Roche Molecular Systems, Inc. December 2020. https://www.fda.gov/media/150278/download. Retrieved 08 September 2021. 
  26. ↑ "Talis One Molecular Testing". Talis Biomedical. https://talisbio.com/talis-one-covid-19-assay/. Retrieved 08 September 2021. 
  27. ↑ O'Connor, L. (11 August 2021). "Despite MDx Product Delays, Talis Biomedical Expecting 'Meaningful Revenue Ramp in 2022'". 360 Dx. Archived from the original on 11 August 2021. https://web.archive.org/web/20210811210316/https://www.360dx.com/business-news/despite-mdx-product-delays-talis-biomedical-expecting-meaningful-revenue-ramp-2022. Retrieved 07 September 2021. 
  28. ↑ "Sofia SARS Antigen FIA". Quidel Corporation. https://www.quidel.com/immunoassays/rapid-sars-tests/sofia-sars-antigen-fia. Retrieved 09 September 2021. 
  29. ↑ Cite error: Invalid <ref> tag; no text was provided for refs named BDVeritor21
  30. ↑ "COVID-19 SARS-CoV-2 Antigen Test". LumiraDx UK Ltd. https://www.lumiradx.com/us-en/what-we-do/diagnostics/test-technology/antigen-test. Retrieved 09 September 2021. 
  31. ↑ "Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag Test (ASPIRE)". ClinicalTrials.gov. National Institutes of Health. 22 October 2020. https://clinicaltrials.gov/ct2/show/NCT04557046. 
  32. ↑ "BinaxNOW COVID-19 Ag CARD" (PDF). Abbott Diagnostics Scarborough, Inc. December 2020. https://www.fda.gov/media/141570/download. Retrieved 09 September 2021. 
  33. ↑ "Sofia 2 Flu + SARS Antigen FIA". Quidel Corporation. https://www.quidel.com/immunoassays/sofia-2-flu-sars-antigen-fia. Retrieved 09 September 2021. 
  34. ↑ "CareStart COVID-19 Antigen". Access Bio, Inc. https://accessbiodiagnostics.net/carestart-covid-19-antigen/. Retrieved 09 September 2021. 
  35. ↑ "Clip COVID Rapid Antigen Test" (PDF). Luminostics, Inc. 2021. https://lib.umso.co/lib_XCpfHrGtBDMqBGId/rphccfc1jrh5j5yz.pdf. Retrieved 09 September 2021. 
  36. ↑ "QuickVue SARS Antigen Test". Quidel Corporation. https://www.quidel.com/immunoassays/quickvue-sars-antigen-test. Retrieved 09 September 2021. 
  37. ↑ "Status COVID-19/Flu A&B - Rapid SARS-CoV-2/Influenza A+B Antigen Panel Test". Princeton BioMeditech Corp. http://www.pbmc.com/products/covid.shtm. Retrieved 09 September 2021. 
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