|
|
| (98 intermediate revisions by the same user not shown) |
| Line 1: |
Line 1: |
| [[File:Eppendorf Mastercycler Pro S.jpg|right|400px|thumb|Eppendorf Mastercycler Pro S, a thermal cycler for PCR and other applications]]
| | {{Saved book |
| '''High- and moderate-complexity CLIA testing'''
| | |title=Introduction to Quality and Quality Management Systems |
| | |subtitle= |
| | |cover-image=Time-Quality-Money.png |
| | |cover-color=#fffccc |
| | | setting-papersize = A4 |
| | | setting-showtoc = 1 |
| | | setting-columns = 1 |
| | }} |
|
| |
|
| Thermal cyclers are the standard instruments for PCR testing. Today, real-time or quantitative (qPCR) systems largely fill this niche. However, [[Digital polymerase chain reaction|digital and droplet digital PCR]] systems are emerging, and they have the benefit of producing even more rapid, precise, sensitive, accurate, and reproducible results, and they are capable of direct quantification and multiplexing. Other instruments and accessories for PCR workflows include proper power supplies, analytical balances, electrophoresis chambers, water and/or dry baths, and mini/micro centrifuges. However, if you're considering the addition of PCR workflow to your laboratory, the thermal cycler is typically where the largest up-front cost will be. As such, it's important to ask yourself critical questions to help guide your acquisition decisions.
| | ==''Introduction to Quality and Quality Management Systems''== |
| | {{ombox |
| | | type = content |
| | | style = width: 500px; |
| | | text = This book should not be considered complete until this message box has been removed. This is a work in progress. |
| | }} |
| | The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems. |
|
| |
|
| As part of their June 2018 survey on PCR equipment, ''Lab Manager'' posed five questions potential buyers should ask before making PCR purchases<ref name="KerkhofPCR18">{{cite web |url=https://www.labmanager.com/surveys/what-to-look-for-in-a-pcr-system-2154 |title=PCR Equipment Survey Results |author=Kerkhof, J. |work=Lab Manager |date=13 June 2018 |accessdate=14 August 2020}}</ref>:
| | ;1. What is quality? |
| | :''Key terms'' |
| | :[[Quality (business)|Quality]] |
| | :[[Quality assurance]] |
| | :[[Quality control]] |
| | :''The rest'' |
| | :[[Data quality]] |
| | :[[Information quality]] |
| | :[[Nonconformity (quality)|Nonconformity]] |
| | :[[Service quality]] |
| | ;2. Processes and improvement |
| | :[[Business process]] |
| | :[[Process capability]] |
| | :[[Risk management]] |
| | :[[Workflow]] |
| | ;3. Mechanisms for quality |
| | :[[Acceptance testing]] |
| | :[[Conformance testing]] |
| | :[[Clinical quality management system]] |
| | :[[Continual improvement process]] |
| | :[[Corrective and preventive action]] |
| | :[[Good manufacturing practice]] |
| | :[[Malcolm Baldrige National Quality Improvement Act of 1987]] |
| | :[[Quality management]] |
| | :[[Quality management system]] |
| | :[[Total quality management]] |
| | ;4. Quality standards |
| | :[[ISO 9000]] |
| | :[[ISO 13485]] |
| | :[[ISO 14000|ISO 14001]] |
| | :[[ISO 15189]] |
| | :[[ISO/IEC 17025]] |
| | :[[ISO/TS 16949]] |
| | ;5. Quality in software |
| | :[[Software quality]] |
| | :[[Software quality assurance]] |
| | :[[Software quality management]] |
|
| |
|
| # Do your current and long-term needs require basic PCR systems, qPCR systems, or digital PCR systems?
| | <!--Place all category tags here--> |
| # What sample formats do you anticipate using?
| |
| # What throughput requirements do you have now and anticipate in the near future?
| |
| # What are you willing to sacrifice in regards to temperature ramp up and cool down times and accuracies?
| |
| # Do you anticipate needing to run more than one independent PCR at the same time (multiblock PCR)?
| |
| | |
| Given the considerable investment that goes into these and other life science instruments, you may want to seek vendors who have a strong track record of supporting and supplying parts for instruments they manufacture and distribute years after the instruments are introduced.<ref name="LMResults20">{{cite web |url=https://www.labmanager.com/surveys/results-from-the-lab-manager-life-science-technology-survey-22257 |title=Results from the Lab Manager Life Science Technology Survey |author=Lab Manager |work=Lab Manager |date=07 April 2020 |accessdate=14 August 2020}}</ref>
| |
| | |
| As for PCR-based assays, the U.S. FDA has issued EUAs for more than 200 of them. The most up-to-date listing is of course found at the [https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas FDA website]. However, sorting through the extra details can be tedious. The Center for Systems Biology at Harvard has been maintaining a [https://csb.mgh.harvard.edu/covid contextual PDF chart] of the various COVID-19 diagnostic tests, which includes information such as run time, manufacturer-supplied data, and published clinical data (when available). This may prove useful in deciding on one or more particular tests. As with many aspects of this pandemic, other factors that may influence your choice of test kit include overall availability, cost, reagents included with the assay, and reagents separately required and their availability.
| |
| | |
| Isothermal amplification techniques have the advantage of not requiring an expensive thermal cycler.<ref name="ThiAColor20">{{cite journal |title=A colorimetric RT-LAMP assay and LAMP-sequencing for detecting SARS-CoV-2 RNA in clinical samples |journal=Science Translational Medicine |author=Thi, V.L.D.; Herbst, K.; Boerner, K. et al. |at=eabc7075 |year=2020 |doi=10.1126/scitranslmed.abc7075 |pmid=32719001}}</ref> Instrument-appropriate reaction vessels, baths, heating units, turbidimeters, thermocyclers, etc. may be required, depending on what type of amplification you're doing. Companies like Meridian Bioscience offer LAMP-based molecular platforms, though they may not offer a specific COVID-19 assay to run on the platform.<ref name="MBAlethia">{{cite web |url=https://www.meridianbioscience.com/platform/molecular/alethia/ |title=Alethia |publisher=Meridian Bioscience |accessdate=14 August 2020}}</ref> As can be seen in Table 1, two isothermal amplification assays that run on their own proprietary instrument have received EUAs and are CLIA-waved, with a third potentially on the way. Using these systems and their COVID-19 assays at the point of care provides a somewhat more attractive option for laboratories wanting to add COVID-19 or even multiplex viral assays to their offerings.
| |
| | |
| | |
| '''CLIA-waived testing'''
| |
| | |
| 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.<ref name="ServiceRadical2020">{{cite journal |title=Radical shift in COVID-19 testing needed to reopen schools and businesses, researchers say |journal=Science |author=Service, R.F. |year=2020 |doi=10.1126/science.abe1546}}</ref><ref name="GuglielmiTheExp20">{{cite journal |title=The explosion of new coronavirus tests that could help to end the pandemic |journal=Nature |author=Guglielmi, G. |volume=583 |pages=506–09 |year=2020 |doi=10.1038/d41586-020-02140-8}}</ref><ref name="TaylorFDA20">{{cite web |url=https://www.medtechdive.com/news/fda-warns-of-covid-19-antigen-test-false-positives-as-report-flags-quidel-o/588349/ |title=FDA warns of COVID-19 antigen test false positives as report flags Quidel on accuracy |author=Taylor, N.P. |work=MedTechDive |date=04 November 2020 |accessdate=20 November 2020}}</ref> 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."<ref name="BDVeritor21">{{cite web |url=https://bdveritor.bd.com/content/dam/bdveritor/pdfs/BD-Veritor-IFU.pdf |format=PDF |title=Veritor System For Rapid Detection of SARS-CoV-2 |publisher=Becton, Dickinson and Company |date=January 2021 |accessdate=09 September 2021}}</ref>
| |
| | |
| {|
| |
| | STYLE="vertical-align:top;"|
| |
| {| class="wikitable" border="1" cellpadding="5" cellspacing="0" width="80%"
| |
| |-
| |
| | 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)
| |
| |-
| |
| ! 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;"|20 March 2020
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Cepheid
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.cepheid.com/coronavirus Xpert Xpress SARS-CoV-2 test]
| |
| | 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)]
| |
| | 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;"|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>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|23 March 2020
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Mesa Biotech Inc.
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.mesabiotech.com/#featured-sarscov-section Accula SARS-CoV-2 test]
| |
| | 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)
| |
| | 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;"|Yes
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | 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>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|27 March 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/id-now-covid-19.html ID NOW COVID-19]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.globalpointofcare.abbott/en/product-details/id-now.html ID NOW]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Molecular (isothermal amplification)
| |
| | 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;"|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.
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|10 June 2020
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Cue Health Inc.
| |
| | 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]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.cuehealth.com/products/how-cue-detects-covid-19/ Cue Health Monitoring System]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Molecular (isothermal amplification)
| |
| | 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;"|"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>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|14 September 2020
| |
| | 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-influenza-a-b-nucleic-acid-test.html cobas SARS-CoV-2 & Influenza A/B 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;"|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;"|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>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|24 September 2020
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Cepheid
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.cepheid.com/coronavirus Xpert Xpress SARS-CoV-2/Flu/RSV test]
| |
| | 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)]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Molecular (RT-PCR)
| |
| | 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;"|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>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|02 October 2020
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|BioFire Diagnostics, LLC
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.biofiredx.com/covid-19/ BioFire Respiratory 2.1 (RP2.1) Panel]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.biofiredx.com/products/filmarray/ BioFire FilmArray Systems]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Molecular (RT-PCR)
| |
| | 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;"|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
| |
| 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>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|17 November 2020
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Lucira Health, Inc.
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.lucirahealth.com/ Lucira COVID-19 All-In-One Test Kit]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|N/A
| |
| | 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;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Yes
| |
| | 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>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|27 November 2020
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Cepheid
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://cepheid.widen.net/s/wt962cbqtf Xpert Omni SARS-CoV-2 test]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://cepheid.widen.net/s/wt962cbqtf GeneXpert Omni 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;"|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.
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|08 February 2021
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Visby Medical, Inc.
| |
| | 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]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|N/A
| |
| | 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;"|Yes
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|No
| |
| | 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>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|05 March 2021
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Cue Health Inc.
| |
| | 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]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.cuehealth.com/products/how-cue-detects-covid-19/ Cue Health Monitoring System]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Molecular (isothermal amplification)
| |
| | 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;"|Yes
| |
| | 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.
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|09 April 2021
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Lucira Health, Inc.
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.lucirahealth.com/ Lucira CHECK-IT COVID-19 Test Kit]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|N/A
| |
| | 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;"|No
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Yes
| |
| | 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.
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|17 June 2021
| |
| | 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%"
| |
| |-
| |
| | 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); OTC = Over the counter
| |
| |-
| |
| ! 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): 83.9%; 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;"|15 December 2020
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Ellume Limited
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.ellumehealth.com/products/consumer-products/covid-home-test/ Ellume COVID-19 Home Test]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.ellumehealth.com/products/consumer-products/covid-home-test/ A mobile phone that supports their app]
| |
| | 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;"|Yes (OTC)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|SARS-CoV-2 Sensitivity (PPA): 94.6%; SARS-CoV-2 Specificity (NPA): 96.9%<ref name="EllumeCOVIDHome">{{cite web |url=https://www.fda.gov/media/144592/download |format=PDF |title=Ellume COVID-19 Home Test |publisher=Ellume Limited |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|16 December 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 Home Test]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.globalpointofcare.abbott/en/product-details/binaxnow-covid-19-home-test-us.html A mobile phone that supports their NAVICA app]
| |
| | 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;"|Yes (Prescription)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|SARS-CoV-2 Sensitivity (PPA): 91.7%; SARS-CoV-2 Specificity (NPA): 100%<ref name="AbbottBinaxNOWHome21">{{cite web |url=https://www.fda.gov/media/144574/download |format=PDF |title=BinaxNOW COVID-19 Ag Card Home Test |publisher=Abbott Diagnostics Scarborough, Inc |date=March 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>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|01 March 2021
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Quidel Corporation
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|QuickVue At-Home COVID-19 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;"|Yes (Prescription)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|SARS-CoV-2 Sensitivity (PPA): 84.8%; SARS-CoV-2 Specificity (NPA): 99.1%<ref name="QuidelQuickVueAtHome21">{{cite web |url=https://www.fda.gov/media/146312/download |format=PDF |title=QuickVue At-Home COVID-19 Test |publisher=Quidel Corporation |date=2021 |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|31 March 2021
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Quidel Corporation
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://quickvueathome.com/ QuickVue At-Home OTC COVID-19 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;"|Yes (OTC)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|SARS-CoV-2 Sensitivity (PPA): 83.5%; SARS-CoV-2 Specificity (NPA): 99.2%<ref name="QuidelQuickVueAtHomeOTC21">{{cite web |url=https://quickvueathome.com/wp-content/uploads/2021/08/EF1500200EN00.pdf |format=PDF |title=QuickVue At-Home OTC COVID-19 Test |publisher=Quidel Corporation |date=May 2021 |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|31 March 2021
| |
| | 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.abbott.com/corpnewsroom/diagnostics-testing/over-the-counter-rapid-COVID-19-testing-in-your-hands.html BinaxNOW COVID-19 Ag Card 2 Home 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;"|Yes
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|SARS-CoV-2 Sensitivity (PPA): 91.7%; SARS-CoV-2 Specificity (NPA): 100%<ref name="AbbottBinaxNOWHomeTwo21">{{cite web |url=https://www.fda.gov/media/147259/download |format=PDF |title=BinaxNOW COVID-19 Ag Card 2 Home Test |publisher=Abbott Diagnostics Scarborough, Inc |date=March 2021 |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|16 April 2021
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Celltrion USA, Inc.
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.celltrion.com/en-us/kit/DiatrustAg Celltrion DiaTrust COVID-19 Ag Rapid 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): 93.33%; SARS-CoV-2 Specificity (NPA): 99.03%<ref name="CelltrionDiaTrust">{{cite web |url=https://www.celltrion.com/en-us/kit/DiatrustAg |title=Celltrion DiaTrust COVID-19 Ag Rapid Test |publisher=Celltrion USA, Inc |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|06 May 2021
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|InBios International, Inc.
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.celltrion.com/en-us/kit/DiatrustAg SCoV-2 Ag Detect Rapid 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): 86.67%; SARS-CoV-2 Specificity (NPA): 100%<ref name="InBiosSCoV2">{{cite web |url=https://inbios.com/scov-2-ag-detecttm-rapid-test/ |title=SCoV-2 Ag Detect Rapid Test |publisher=InBios International, Inc |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|20 May 2021
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Salofa Oy
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.celltrion.com/en-us/kit/DiatrustAg Sienna-Clarity COVID-19 Antigen Rapid Test Cassette]
| |
| | 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 Relative Sensitivity: 87.5%; SARS-CoV-2 Relative Specificity: 98.9% (note that it's relative)<ref name="SalofaSiennaClarity">{{cite web |url=https://www.fda.gov/media/149055/download |format=PDF |title=Sienna-Clarity COVID-19 Antigen Rapid Test Cassette |publisher=Salofa Oy |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|04 June 2021
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|OraSure Technologies, Inc.
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://inteliswab.com/ InteliSwab COVID-19 Rapid 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;"|Yes (OTC)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|SARS-CoV-2 Sensitivity (PPA): 84.3%; SARS-CoV-2 Specificity (NPA): 97.9%<ref name="OraSureInteliSwabRapid">{{cite web |url=https://www.fda.gov/media/149911/download |format=PDF |title=InteliSwab COVID-19 Rapid Test |publisher=OraSure Technologies, Inc |date-May 2021 |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|04 June 2021
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|OraSure Technologies, Inc.
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://inteliswab.com/ InteliSwab COVID-19 Rapid Test Rx]
| |
| | 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;"|Yes (Prescription)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|SARS-CoV-2 Sensitivity (PPA): 84.3%; SARS-CoV-2 Specificity (NPA): 97.9%<ref name="OraSureInteliSwabRapidRx">{{cite web |url=https://www.fda.gov/media/149906/download |format=PDF |title=InteliSwab COVID-19 Rapid Test Pro Rx |publisher=OraSure Technologies, Inc |date-May 2021 |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|04 June 2021
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|OraSure Technologies, Inc.
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://inteliswab.com/ InteliSwab COVID-19 Rapid Test Pro]
| |
| | 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): 84.3%; SARS-CoV-2 Specificity (NPA): 97.9%<ref name="OraSureInteliSwabPro">{{cite web |url=https://inteliswab.com/wp-content/uploads/2021/08/3001-3455-0521-COVID-19-Rapid-Test-Pro-IFU_2.pdf |format=PDF |title=InteliSwab COVID-19 Rapid Test Pro |publisher=OraSure Technologies, Inc |date-May 2021 |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|08 July 2021
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Ellume Limited
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.ellumehealth.com/products/professional-products/ellumelab/ ellume.lab COVID Antigen Test]
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.ellumehealth.com/products/professional-products/ellumelab/ ellume.lab digital device]
| |
| | 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): 81.8%; SARS-CoV-2 Specificity (NPA): 100%<ref name="EllumeCOVID">{{cite web |url=https://www.fda.gov/media/150687/download |format=PDF |title=ellume·lab COVID Antigen Instructions for Use |publisher=Ellume Limited |date-30 June 2021 |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|13 July 2021
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|GenBody Inc.
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[http://genbody.co.kr/bbs/board.php?bo_table=human01&wr_id=22 GenBody COVID-19 Ag]
| |
| | 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): 96.0%; SARS-CoV-2 Specificity (NPA): 99.28%<ref name="GenBodyCOVIDAg">{{cite web |url=http://genbody.co.kr/bbs/board.php?bo_table=human01&wr_id=22 |title=COVID-19 Ag |publisher=GenBody Inc |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|28 July 2021
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|PHASE Scientific International, Ltd.
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://us.phasescientific.com/antigen-test/ INDICAID COVID-19 Rapid 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): 84.4%; SARS-CoV-2 Specificity (NPA): 96.6% (average of health-care-provider-collected and self-collected)<ref name="PHASEIndicaid21">{{cite web |url=https://us.phasescientific.com/wp-content/uploads/2021/08/05a_eua210259.phase-indicaid-ag.IFU-07-28-2021.pdf |format=PDF |title=INDICAID COVID-19 Rapid Antigen Test |publisher=PHASE Scientific International, Ltd. |date=July 2021 |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|02 August 2021
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Access Bio, Inc.
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|CareStart COVID-19 Antigen Home Test (Not on website yet)
| |
| | 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;"|Yes (OTC)
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|SARS-CoV-2 Sensitivity (PPA): 86.6%; SARS-CoV-2 Specificity (NPA): 97.6% (Note: average of swab types)<ref name="AccessBioCOVID19AntigenHome21">{{cite web |url=https://www.fda.gov/media/151248/download |title=CareStart COVID-19 Antigen Home Test |publisher=Access Bio, Inc |date=02 August 2021 |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|24 August 2021
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|Becton, Dickinson and Company
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|BD Veritor At-Home COVID-19 Test (Not on website yet)
| |
| | 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;"|Yes
| |
| | style="background-color:white; padding-left:10px; padding-right:10px;"|SARS-CoV-2 Sensitivity (PPA): 84.6%; SARS-CoV-2 Specificity (NPA): 99.8%<ref name="BDVeritorAtHome21">{{cite web |url=https://www.fda.gov/media/151761/download |format=PDF |title=BD Veritor At-Home COVID-19 Test |publisher=ecton, Dickinson and Company |date=July 2021 |accessdate=09 September 2021}}</ref>
| |
| |-
| |
| |}
| |
| |}
| |
| | |
| ==References==
| |
| {{Reflist|colwidth=30em}}
| |
