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If you're running a POL, or attempting to provide COVID-19 testing at the point of care, you'll be looking at the following molecular diagnostic assays (Table 1) and antigen diagnostic assays (Table 2), depending on the level of accuracy and purpose of use required in your POL. Remember that—broadly speaking—antigen tests tend to have lower sensitivities than molecular tests, leaving antigen tests best used as surveillance or repeat screening tools.[1][2][3] For example, the directions for the BD Veritor System for Rapid Detection of SARS-CoV-2 manufactured by Becton, Dickinson and Company state: "Sensitivity of the test after the first five days of the onset of symptoms has been demonstrated to decrease as compared to a RT-PCR SARS-CoV-2 assay."[4]
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- ↑ Service, R.F. (2020). "Radical shift in COVID-19 testing needed to reopen schools and businesses, researchers say". Science. doi:10.1126/science.abe1546.
- ↑ Guglielmi, G. (2020). "The explosion of new coronavirus tests that could help to end the pandemic". Nature 583: 506–09. doi:10.1038/d41586-020-02140-8.
- ↑ Taylor, N.P. (4 November 2020). "FDA warns of COVID-19 antigen test false positives as report flags Quidel on accuracy". MedTechDive. https://www.medtechdive.com/news/fda-warns-of-covid-19-antigen-test-false-positives-as-report-flags-quidel-o/588349/. Retrieved 20 November 2020.
- ↑ 4.0 4.1 "Veritor System For Rapid Detection of SARS-CoV-2" (PDF). Becton, Dickinson and Company. January 2021. https://bdveritor.bd.com/content/dam/bdveritor/pdfs/BD-Veritor-IFU.pdf. Retrieved 09 September 2021.
- ↑ 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.
- ↑ 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.
- ↑ 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.
- ↑ 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.
- ↑ "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"
- ↑ 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.
- ↑ 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.
- ↑ 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.
- ↑ 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.
- ↑ 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.
- ↑ 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.
- ↑ "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"
- ↑ 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.
- ↑ "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.
- ↑ 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.
- ↑ 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.
- ↑ 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.
- ↑ [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.
- ↑ 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.
- ↑ "Lucira Health COVID-19 All-In-One Test Kit". Lucira Health, Inc. 2020. https://www.fda.gov/media/143809/download. Retrieved 20 November 2020.
- ↑ "Xpert Omni SARS-CoV-2" (PDF). Cepheid. April 2021. https://www.fda.gov/media/144033/download. Retrieved 08 September 2021.
- ↑ "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.
- ↑ "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.
- ↑ "Cue’s COVID‑19 Diagnostic Test". Cue Health, Inc. https://www.cuehealth.com/products/how-cue-detects-covid-19/. Retrieved 08 September 2021.
- ↑ "cobas SARS-CoV-2". Roche Molecular Systems, Inc. December 2020. https://www.fda.gov/media/150278/download. Retrieved 08 September 2021.
- ↑ "Talis One Molecular Testing". Talis Biomedical. https://talisbio.com/talis-one-covid-19-assay/. Retrieved 08 September 2021.
- ↑ 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.
- ↑ "Sofia SARS Antigen FIA". Quidel Corporation. https://www.quidel.com/immunoassays/rapid-sars-tests/sofia-sars-antigen-fia. Retrieved 09 September 2021.
- ↑ "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.
- ↑ "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.
- ↑ "BinaxNOW COVID-19 Ag CARD" (PDF). Abbott Diagnostics Scarborough, Inc. December 2020. https://www.fda.gov/media/141570/download. Retrieved 09 September 2021.
- ↑ "Sofia 2 Flu + SARS Antigen FIA". Quidel Corporation. https://www.quidel.com/immunoassays/sofia-2-flu-sars-antigen-fia. Retrieved 09 September 2021.
- ↑ "CareStart COVID-19 Antigen". Access Bio, Inc. https://accessbiodiagnostics.net/carestart-covid-19-antigen/. Retrieved 09 September 2021.
- ↑ "Clip COVID Rapid Antigen Test" (PDF). Luminostics, Inc. 2021. https://lib.umso.co/lib_XCpfHrGtBDMqBGId/rphccfc1jrh5j5yz.pdf. Retrieved 09 September 2021.
- ↑ "QuickVue SARS Antigen Test". Quidel Corporation. https://www.quidel.com/immunoassays/quickvue-sars-antigen-test. Retrieved 09 September 2021.
- ↑ "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.
- ↑ "Celltrion DiaTrust COVID-19 Ag Rapid Test". Celltrion USA, Inc. https://www.celltrion.com/en-us/kit/DiatrustAg. Retrieved 09 September 2021.
- ↑ 42.0 42.1 "SCoV-2 Ag Detect Rapid Test". InBios International, Inc. https://inbios.com/scov-2-ag-detecttm-rapid-test/. Retrieved 09 September 2021.
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tag; name "InBiosSCoV2" defined multiple times with different content - ↑ "InteliSwab COVID-19 Rapid Test Pro" (PDF). OraSure Technologies, Inc. https://inteliswab.com/wp-content/uploads/2021/08/3001-3455-0521-COVID-19-Rapid-Test-Pro-IFU_2.pdf. Retrieved 09 September 2021.
- ↑ "ellume·lab COVID Antigen Instructions for Use" (PDF). Ellume Limited. https://www.fda.gov/media/150687/download. Retrieved 09 September 2021.
- ↑ 45.0 45.1 "COVID-19 Ag". GenBody Inc. http://genbody.co.kr/bbs/board.php?bo_table=human01&wr_id=22. Retrieved 09 September 2021.
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