View source for COVID-19 Testing, Reporting, and Information Management in the Laboratory/Adding COVID-19 and other virus testing to your laboratory/What kind of space, equipment, and supplies will you need?

===3.2 What kind of space, equipment, and supplies will you need?===
====3.2.1 Laboratory space arrangements====
'''PCR considerations'''

Whether adding PCR to your existing laboratory, modifying existing PCR workflows, or starting from scratch, preventing contamination is a top priority. As PCR can effectively amplify even the tiniest of quantities of DNA and RNA, the risk of amplifying a contaminant and ruining the validity of an assay is very real.<ref name="MifflinSetting03">{{cite book |url=http://www.biosupplynet.com/pdf/01_pcr_primer_p.5_14.pdf |format=PDF |chapter=Chapter 1: Setting Up a PCR Laboratory |title=PCR Primer |author=Mifflin, T.E. |editor=Dieffenbach, C.; Dveksler, G. |edition=2nd |publisher=Cold Spring Harbor Laboratory Press |pages=5–14 |year=2003 |isbn=9780879696542 |accessdate=13 August 2020}}</ref><ref name="RochePCR06">{{cite book |url=https://www.gene-quantification.de/ras-pcr-application-manual-3rd-ed.pdf |format=PDF |chapter=Chapter 2: General Guidelines |title=PCR Applications Manual |editor=Degen, H.-J.; Deufel, A.; Eisel, D. et al. |edition=3rd |publisher=Roche Diagnostics GmbH |pages=19–38 |year=2006 |accessdate=13 August 2020}}</ref><ref name="AhmedSetting14">{{cite book |url=http://grcpk.com/wp-content/uploads/2014/10/12.-Setting-up-PCR-Lab.pdf |format=PDF |chapter=Chapter 12: Setting-up a PCR Lab |title=Manual of PCR |author=Ahmed, S. |publisher=Genetics Resource Centre |year=2014 |accessdate=13 August 2020}}</ref><ref name="RedigTheDevil14">{{cite web |url=https://bitesizebio.com/19880/the-devil-is-in-the-details-how-to-setup-a-pcr-laboratory/ |title=The Devil is in the Details: How to Setup a PCR Laboratory |author=Redig, J. |work=BiteSizeBio |date=01 August 2014 |accessdate=13 August 2020}}</ref><ref name="BioChekTheBasics18">{{cite web |url=https://www.biochek.com/wp-content/uploads/2018/05/BioChek-E-book-The-basics-of-PCR.pdf |format=PDF |title=The basics of PCR: Detecting viruses and bacteria red-handed |publisher=BioChek BV |date=May 2018 |accessdate=13 August 2020}}</ref><ref name="DasMitig18">{{cite journal |title=Mitigating PCR /Amplicon Contamination in a High Risk High Burden Mycobacterial Reference Laboratory in a Resource Limited Setting |journal=Mycobacterial Diseases |author=Das, P.K.; Ganguly, S.B.; Mandal, B. |volume=8 |issue=2 |at=261 |year=2018 |doi=10.4172/2161-1068.1000261}}</ref><ref name="WHODos18">{{cite web |url=https://www.who.int/teams/global-malaria-programme/case-management/diagnosis/nucleic-acid-amplification-based-diagnostics/dos-and-don-ts-for-molecular-testing |title=Dos and Don'ts for molecular testing |author=World Health Organization |publisher=World Health Organization |date=31 January 2018 |accessdate=08 September 2021}}</ref> Contamination typically comes from non-amplified environmental substances such as aerosols, and from carryover contamination of amplicons from earlier PCR cycles. As such, not only do best-practice processes and procedures (P&P) need to be followed (e.g., unidirectional workflow, thorough cleaning procedures, proper preparation and disposal), but also where to place PCR-related equipment must be carefully considered.<ref name="MifflinSetting03" /><ref name="RochePCR06" /><ref name="RedigTheDevil14" /><ref name="DasMitig18" /> 

When possible, separate rooms for sample preparation, PCR setup, and post-PCR activities, each with their own airflow control, are encouraged.<ref name="MifflinSetting03" /><ref name="RochePCR06" /><ref name="BioChekTheBasics18" /><ref name="DasMitig18" /><ref name="WHODos18" /> However, the laboratory attempting to add PCR to an already small clinical diagnostic lab may not have the luxury of having multiple rooms. In that case, a single-room setup may suffice, if the workflow areas remain demarcated or physically partitioned. Additionally, a single-room setup must also have stricter P&P and design controls to offset the space constraints. For example, the sample preparation area of the room should have a laminar flow hood with UV light that is regularly cleaned, and post-PCR analysis may need to occur later in the day after cleanup from prior steps.<ref name="MifflinSetting03" /><ref name="AhmedSetting14" /><ref name="WHODos18" /> Of course, always maintaining unidirectional workflow—regardless of number of rooms—is also critical to minimizing contamination. For example, technicians shouldn't be transporting amplified materials into the DNA extraction area. 

Although dated, Roche Diagnostics' 2006 ''[https://www.gene-quantification.de/ras-pcr-application-manual-3rd-ed.pdf PCR Applications Manual]''<ref name="RochePCR06" /> provides a detailed breakdown of setting up the laboratory for PCR. [https://www.longdom.org/open-access/mitigating-pcr-amplicon-contamination-in-a-high-risk-high-burden-mycobacterial-reference-laboratory-in-a-resource-limited-setting-2161-1068-1000261.pdf Das ''et al.'']<ref name="DasMitig18" />  and [https://bitesizebio.com/19880/the-devil-is-in-the-details-how-to-setup-a-pcr-laboratory/ Dr. Jennifer Redig]<ref name="RedigTheDevil14" /> provide additional valuable insight. The World Health Organization (WHO) also provides [https://www.who.int/teams/global-malaria-programme/case-management/diagnosis/nucleic-acid-amplification-based-diagnostics/dos-and-don-ts-for-molecular-testing guidance] for setting up molecular testing in the lab.<ref name="WHODos18" />

'''Isothermal amplification considerations'''

Similarly, because DNA and RNR amplification is involved, contamination concerns exist with isothermal amplification techniques. Multiple pipetting steps and repeated freezing and thawing of reagents can still lead to cross-contamination<ref name="DiegoProgress19">{{cite journal |title=Progress in loop-mediated isothermal amplification assay for detection of Schistosoma mansoni DNA: Towards a ready-to-use test |journal=Scientific Reports |author=Diego, J. G.-B.; Fernández-Soto, P.; Crego-Vicente, B. et al. |volume=9 |at=14744 |year=2019 |doi=10.1038/s41598-019-51342-2 |pmid=31611563 |pmc=PMC6791938}}</ref>, as does opening the reaction chamber after reaction is completed.<ref name="MartzyChall19">{{cite journal |title=Challenges and perspectives in the application of isothermal DNA amplification methods for food and water analysis |journal=Analytical and Bioanalytical Chemistry |author=Martzy, R.; Kolm, C.; Krska, R. et al. |volume=411 |pages=1695–1702 |year=2019 |doi=10.1007/s00216-018-1553-1 |pmid=30617408 |pmc=PMC6453865}}</ref> However, the advent of microfluidics and lateral flow technologies in isothermal amplification processes has seen the development of "fully enclosed microstructured devices into which performing the isothermal amplification reduces the risk of sample contamination and allows integration and portable device realization."<ref name="ZanoliIsotherm13">{{cite journal |title=Isothermal Amplification Methods for the Detection of Nucleic Acids in Microfluidic Devices |journal=Biosensors |author=Zanoli, L.M.; Spoto, G. |volume=3 |issue=1 |pages=18–43 |year=2013 |doi=10.3390/bios3010018 |pmid=25587397 |pmc=PMC4263587}}</ref><ref name="RoskosSimple13">{{cite journal |title=Simple System for Isothermal DNA Amplification Coupled to Lateral Flow Detection |journal=PLoS One |author=Roskos, K.; Hickerson, A.I.; Lu, H.-W. et al. |volume=8 |issue=7 |at=e69355 |year=2013 |doi=10.1371/journal.pone.0069355 |pmid=23922706 |pmc=PMC3724848}}</ref> Even more cutting-edge techniques to reduce contamination such as the CUT-LAMP technique of Bao ''et al.''<ref name="BaoCUT20">{{cite journal |title=CUT-LAMP: Contamination-Free Loop-Mediated Isothermal Amplification Based on the CRISPR/Cas9 Cleavage |journal=ACS Sensors |author=Bao, Y.; Jiang, Y.; Xiong, E. et al. |volume=5 |issue=4 |pages=1082–91 |year=2020 |doi=10.1021/acssensors.0c00034 |pmid=32242409}}</ref> or the dUTP/UDG system for COVID-19 RT-LAMP reactions of Kellner ''et al.''<ref name="KellnerARapid20">{{cite journal |title=A rapid, highly sensitive and open-access SARS-CoV-2 detection assay for laboratory and home testing |journal=bioRxiv |author=Kellner, M.J.; Ross, J.J.; Schnabl, J. et al. |year=2020 |doi=10.1101/2020.06.23.166397}}</ref> hold further promise in making isothermal amplification processes in the laboratory easier to manage. That said, labs running isothermal amplification processes such as LAMP requiring analysis with agarose gel electrophoresis or a method requiring the opening of reaction vessels will preferably have a secondary area set up for analysis steps so as to minimize the chances of contamination.<ref name="NEBLoop14">{{cite web |url=https://www.neb.com/protocols/2014/06/17/loop-mediated-isothermal-amplification-lamp |title=Loop-mediated Isothermal Amplification (LAMP) |publisher=New England BioLabs |date=17 June 2014 |accessdate=14 August 2020}}</ref><ref name="Fernández-SotoDevelop14">{{cite journal |title=Development of a Highly Sensitive Loop-Mediated Isothermal Amplification (LAMP) Method for the Detection of ''Loa loa'' |journal=PLoS One |author=Fernández-Soto, P.; Mvoulouga, P.O.; Akue, J.P. et al. |volume=9 |issue=4 |at=e94664 |year=2014 |doi=10.1371/journal.pone.0094664 |pmid=24722638 |pmc=PMC3983228}}</ref>

====3.2.2 Instruments and assays====
[[File:Eppendorf Mastercycler Pro S.jpg|right|400px|thumb|Eppendorf Mastercycler Pro S, a thermal cycler for PCR and other applications]]
'''High- and moderate-complexity CLIA testing'''

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.

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>:

# Do your current and long-term needs require basic PCR systems, qPCR systems, or digital PCR systems?
# 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>
 |-
|}
|}

====3.2.3 Reagents====
'''High- and moderate-complexity CLIA testing'''

At various times during the pandemic, reagent shortages have hampered many efforts to expand testing in parts of the world, including the United States. For the attentive laboratory wanting to remain agile in its testing, the laboratory's reagent choices will likely be closely tied to both the assays it chooses to implement and how reliably the supplier can get them to the lab. This in turn is likely driven by whether the lab is using a lab-developed test or a test kit. In some cases, e.g., the Xiamen Zeesan Biotech SARS-CoV-2 Test Kit (Real-time PCR), all but the Virus RNA Extraction Kit is included.<ref name="FDAXiamenSARS20">{{cite web |url=https://www.fda.gov/media/140717/download |format=PDF |title=SARS-CoV-2 Test Kit (Real-time PCR) Instructions for Use |publisher=Xiamen Zeesan Biotech |date=July 2020 |accessdate=14 August 2020}}</ref> On the other hand, Biomeme's SARS-CoV-2 Real-Time RT-PCR Test requires the separate acquisition of PCR buffer and external controls other than the exogenous RNA Process Control that comes with the kit.<ref name="FDABiomemeSARS20">{{cite web |url=https://www.fda.gov/media/141052/download |format=PDF |title=Biomeme SARS-CoV-2 Real-Time RT-PCR Test Instructions for Use |publisher=Biomeme, Inc |date=2020 |accessdate=14 August 2020}}</ref> Yale's SalivaDirect is a more flexible test, validated for use with multiple instruments and reagents that are not proprietary to Yale.<ref name="GallagherFDA20">{{cite web |url=https://www.contagionlive.com/view/fda-grants-emergency-covid19-authorization-yale-open-source-method-saliva-testing |title=FDA Grants Emergency COVID-19 Authorization to Yale's Open Source Method of Saliva Testing |author=Gallagher, G.M. |work=ContagionLive |date=15 August 2020 |accessdate=16 August 2020}}</ref><ref name="ZillgittFDA20">{{cite web |url=https://www.usatoday.com/story/sports/nba/2020/08/15/fda-approves-covid-19-saliva-test-developed-yale-nba-nbpa-aid/5590452002/ |title=FDA approves COVID-19 saliva test developed at Yale in partnership with the NBA, NBPA |author=Zillgitt, J. |work=USA Today |date=15 August 2020 |accessdate=16 August 2020}}</ref> Pay close attention to what comes with the assay, typically by reviewing the instructions for use (IFU; found on the FDA's EUA page).

For PCR, the five basic reagents are template DNA, PCR primers, nucleotides, PCR buffer, and thermostable DNA polymerase. Some of these components can be acquired pre-mixed as a "master mix." For example, Thermo Fisher's PCR Master Mix contains a thermostable DNA polymerase called ''Taq'', nucleotides called deoxynucleotide triphosphates (dNTPs), and a buffer, which "saves time and reduces contamination due to a reduced number of pipetting steps."<ref name="TFSPCRMaster">{{cite web |url=https://www.thermofisher.com/order/catalog/product/K0171#/K0171 |title=PCR Master Mix (2X) |publisher=Thermo Fisher Scientific |accessdate=16 August 2020}}</ref>

Reagent cost and usage for isothermal amplification methods such as LAMP are similar, though buffers and primers specific to the method are required.<ref name="DiegoProgress19" /><ref name="NEBLoop14" /><ref name="OGIsoth">{{cite web |url=http://www.optigene.co.uk/isothermal-reaction-guide/ |title=Isothermal Reaction Guide |publisher=OptiGene Limited |accessdate=16 August 2020}}</ref><ref name="KashirLoop20">{{cite journal |title=Loop mediated isothermal amplification (LAMP) assays as a rapid diagnostic for COVID-19 |journal=Medical Hypotheses |author=Kashir, J.; Yaqinuddin, A. |volume=141 |at=109786 |year=2020 |doi=10.1016/j.mehy.2020.109786 |pmid=32361529 |pmc=PMC7182526 |quote=Reagent-wise, the costs would be similar to that of real time RT-PCR ...}}</ref>

'''CLIA-waived testing'''

The FDA EUA devices (Table 1 and 2) all come with the necessary reagents, with the exception of any controls or references you may require. Refer to the IFU for the waived test kit to determine what additional consumables you'll require.

====3.2.4 Consumables====
'''High- and moderate-complexity CLIA testing'''

Non-reagent consumables for high- and moderate-complexity CLIA testing include PCR tubes and plates; pipettes and tips; films, foils, and sealing mats; swabs; and viral transport media, among others. Some like Kellner ''et al.'' have experimented with methods to make isothermal amplifications methods more approachable in resource-poor environments by, for example, developing a pipette-free version of LAMP.<ref name="KellnerARapid20" />

'''CLIA-waived testing'''

The FDA EUA devices (Table 1 and 2) may require a few extra consumables. For example, the Accula SARS-CoV-2 test kit comes with swabs<ref name="MBAccula20">{{cite web |url=https://www.fda.gov/media/136355/download |format=PDF |title=Accula Test |publisher=Mesa Biotech, Inc |date=April 2020 |accessdate=16 August 2020}}</ref> and the Xpert Xpress SARS-CoV-2 kit comes with disposable transfer pipettes.<ref name="CepheidXpert20">{{cite web |url=https://www.fda.gov/media/136315/download |format=PDF |title=Xpert Xpress SARS-CoV-2 |publisher=Cepheid |date=March 2020 |accessdate=16 August 2020}}</ref> Refer to the IFU for the waived test kit to determine what additional consumables you'll require.

====3.2.5 Software and services====
A June 2020 report by Weemaes ''et al.'' in the ''Journal of the American Medical Informatics Association'' describes the bottlenecks they encountered in their test workflows at the Belgian National Reference Center, and how they updated their LIS with functionality to resolve those bottlenecks.<ref name="WeemaesLab20">{{cite journal |title=Laboratory information system requirements to manage the COVID-19 pandemic: A report from the Belgian national reference testing center |journal=JAMIA |author=Weemaes, M.; Martens, S.; Cuypers, L. et al. |at=ocaa081 |year=2020 |doi=10.1093/jamia/ocaa081 |pmid=32348469 |pmc=PMC7197526}}</ref> In addition to adding a COVID-19–specific order set into the [[computerized physician order entry]] (CPOE) module integrated with both their LIS and [[electronic health record]] (EHR), they included an up-to-date triage criteria component, a tool for optimizing sampling and packaging, a COVID-19 status button, and improved reporting modules for automating reference testing and epidemiological reporting. They also added extra database and data mining functionality to facilitate research and insights into epidemiologies and treatments. Their conclusion: "Rapidly developed, agile extendable LIS functionality and its meaningful use alleviates the administrative burden on laboratory personnel and improves turnaround time of SARS-CoV-2 testing."<ref name="WeemaesLab20" /> The Association of Public Health Laboratories comes to a similar conclusion in regard to laboratory informatics solutions and public health laboratories' COVID-19 testing.<ref name="APHLLIMS20">{{cite web |url=https://www.aphl.org/aboutAPHL/publications/Documents/INFO-2020-LIMS.pdf |format=PDF |title=LIMS (Laboratory Information Management System) |author=Association of Public Health Laboratories |publisher= Association of Public Health Laboratories |date=2020 |accessdate=18 August 2020}}</ref>

As such, adding COVID-19 and other respiratory illness testing to your workflow may necessitate an information management system, or an upgrade of your existing software systems. You may experience many of the same bottlenecks the Belgian National Reference Center experienced, especially if you're still working primarily with paper-based test ordering. Those researchers found that paper-based COVID-19 test requests often<ref name="WeemaesLab20" />:

* omitted critical clinical status and contact information;
* slowed down epidemiological and research studies;
* hindered proper pre-analytical biosafety procedures; and
* impeded rapid response to evolving test criteria and clinical insights through test ordering protocols.

How interoperable your laboratory software solution is with other systems such as EHRs is also worth consideration. The next chapter addresses system interoperability in greater detail, but it's worth mentioning it here in the context of adding software to improve testing workflows for SARS-CoV-2 and other respiratory viruses. Broadly speaking, improving interoperability among [[clinical informatics]] systems—whether at the point of care or within a specific laboratory—is recognized as an important step towards improving health outcomes.<ref name="KunImprov08">{{cite journal |title=Improving outcomes with interoperable EHRs and secure global health information infrastructure |journal=Studies in Health Technology and Informatics |author=Kun, L.; Coatrieux, G.; Quantin, C. et al. |volume=137 |pages=68–79 |year=2008 |pmid=18560070}}</ref><ref name="GCHIImproving">{{cite web |url=http://s3.amazonaws.com/rdcms-himss/files/production/public/Improving-Patient-Carethrough-Interoperability.pdf |format=PDF |title=Improving Patient Care through Interoperability |author=Global Center for Health Innovation |publisher=Global Center for Health Innovation |date=n.d. |accessdate=16 August 2020}}</ref> However, while developers of EHRs and other clinical informatics systems have intended to improve their software's interoperability, the COVID-19 pandemic has, at times, unfortunately shown the inadequacies still inherent in that software's overall design.<ref name="GlaserItsTime20">{{cite web |url=https://hbr.org/2020/06/its-time-for-a-new-kind-of-electronic-health-record |title=It’s Time for a New Kind of Electronic Health Record |author=Glaser, J. |work=Harvard Business Review |date=12 June 2020 |accessdate=18 August 2020}}</ref><ref name="LimoliPhys20">{{cite web |url=https://medcitynews.com/2020/07/physicians-deserve-better-software-covid-19-has-shown-why-medical-records-need-to-adapt/ |title=Physicians deserve better software: Covid-19 has shown why medical records need to adapt |author=Limoli, C.; Papathomas, G. |work=MedCity News |date=07 July 2020 |accessdate=18 August 2020}}</ref><ref name="JasonEHR20">{{cite web |url=https://ehrintelligence.com/news/ehr-optimization-health-it-projects-needed-after-covid-19-surge |title=EHR Optimization, Health IT Projects Needed After COVID-19 Surge |author=Jason, C. |work=EHR Intelligence |date=23 July 2020 |accessdate=18 August 2020}}</ref><ref name="ReevesTheClin21">{{cite journal |title=The Clinical Information Systems Response to the COVID-19 Pandemic |journal=Yearbook of Medical Informatics |author=Reeves, J.J.; Pageler, N.M.; Wick, E.C. et al. |volume=30 |issue=1 |pages=105–25 |year=2021 |doi=10.1055/s-0041-1726513 |pmid=34479384 |pmc=PMC8416224}}</ref> As such, any research into acquiring a [[laboratory information management system]] (LIMS), LIS, or other clinical information management solution should take into account how well that solution is able to integrate with your other clinical systems, as well as any other third-party systems like physician or hospital EHRs. And it's not just the software solutions you'll want to consider. Will the new instruments you add for getting your lab rolling with clinical respiratory illness testing integrate with your software?

Finally, although rare, you may find you don't have the in-house expertise to fully implement a COVID-19 testing line to your laboratory. In such a case, you may need to turn to a laboratory services consultancy with experience in SARS-CoV-2 test method validation, instrument procurement and implementation, and legal matters. (See the next section for a representative example of consultants advertising COVID-19 testing knowledge and services for labs.)

====3.2.6 Major vendors and consultants====
Table 3 lists the major vendors developing and selling PCR, isothermal amplification, and NGS supplies, instruments, and software for both clinical diagnostics and life science research. "Research use only" equipment like Siemens Healthcare's Fast Track Cycler was ignored for completing the table. The vendor list was largely compiled from vendors identified in a handful of online market reports on PCR, with an added sprinkling of a few additional reagent vendors (e.g., Jena Bioscience, LGC, and New England BioLabs) who address isothermal amplification supplies in addition to PCR. Note that this is not an endorsement for any particular vendor.
{| 
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{| class="wikitable sortable" border="1" cellpadding="5" cellspacing="0" width="90%"
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  ! style="background-color:white; text-align:left; font-weight: normal; padding-left:10px; padding-right:10px;" colspan="13"|'''Table 3.''' Major players operating in the global diagnostic PCR, isothermal amplification, and NGS market
 |- 
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Vendor
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Shop all products
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|PCR machines
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Nucleic acid extraction<br />and purification machines
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Immunoassay analyzers<br />and assays
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|PCR and qPCR assays
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|PCR and qPCR enzymes<br />and master mixes
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|DNA/RNA purification,<br />quantitation, and<br />amplification supplies
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|LAMP assays
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Isothermal amplification<br />enzymes and <br />master mixes
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|NGS supplies
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Supporting labware<br />and supplies
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Software
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Abbott
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.molecular.abbott/us/en/offerings/products Abbott products]
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Agilent Technologies
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.agilent.com/en-us/products Agilent products]
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  | 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://www.bd.com/en-us/offerings/capabilities BD products]
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Bio-Rad Laboratories, Inc.
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.bio-rad.com/en-us/life-science-research?ID=1100 Bio-Rad products]
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|bioMérieux SA
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.biomerieux-usa.com/az bioMérieux products]
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Danaher Corporation and its companies
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.cepheid.com/ Cepheid products],<br />[https://www.beckmancoulter.com/en/products Beckman Coulter products], and<br />[https://www.beckman.com/ Beckman Life Sciences products]
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|F. Hoffmann-La Roche AG
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.roche.com/products/diagnostics-portfolio.htm Roche Diagnostics products]
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Jena Bioscience GmbH
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.jenabioscience.com/ Jena Bioscience products]
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|LGC Limited and its companies
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.lucigen.com/products.html Lucigen products]
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Merck KGaA
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.sigmaaldrich.com/US/en/life-science/covid Sigma-Aldrich products] and<br />[https://www.emdmillipore.com/US/en/products/vMqb.qB.GdEAAAE_Mhd3.Lxj,nav Millipore Sigma products]
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|New England BioLabs, Inc.
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.neb.com/products NEB products]
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
 |-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|Promega
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.promega.com/products/ Promega products] and [https://www.promega.com/products/catalog/ catalog]
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
 |-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|QIAGEN N.V.
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.qiagen.com/us/products/ QIAGEN products]
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
 |-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|Siemens Healthcare GmbH
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.siemens-healthineers.com/products-services Siemens Healthcare products]
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
 |-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|Thermo Fisher Scientific, Inc.
  | style="background-color:white; padding-left:10px; padding-right:10px;"|[https://www.thermofisher.com/us/en/home/order.html Thermo Fisher products] and<br />[https://www.fishersci.com/us/en/browse/90217008/pcr-equipment-and-supplies Fisher Scientific products]
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"| -
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓ 
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
  | style="background-color:white; padding-left:10px; padding-right:10px;"|✓
 |-
|}
|}

The "Software" column of Table 3 represents whether or not the vendor offers laboratory informatics software such as a LIMS or LIS. Those vendors' solutions may or may not be tailored to handle the specific requirements of a clinical diagnostic or virology lab handling COVID-19 and other viruses. (See the next chapter for more in-depth information about working an informatics solution into COVID-19 and other viral testing workflow.) A non-endorsed, representative example of vendors who do include:

* [[Vendor:Abbott Informatics Corporation|Abbott Informatics Corporation]] - [https://www.starlims.com/us/en/covid19-testing-and-reporting/starlims-covid19 STARLIMS LIMS]
* [[Vendor:AgileBio|AgileBio]] - [https://labcollector.com/solutions/applications/lp-covid19-pack/ COVID-19 LC]
* [[Vendor:Autoscribe Informatics, Inc.|Autoscribe Informatics, Inc.]] -  [https://www.autoscribeinformatics.com/lims/matrix-covid-lims Matrix Covid LIMS]
* [[Vendor:BioSoft Integrators, LLC|BioSoft Integrators, LLC]] - [https://biosoftintegrators.com/covid-19/ LabOptimize LIMS for COVID-19]
* [[Vendor:CloudLIMS.com, LLC|CloudLIMS.com, LLC]] - [https://cloudlims.com/industries/covid-19-lims-software.html CloudLIMS for COVID-19]
* [[Vendor:Common Cents Systems, Inc.|Common Cents Systems, Inc.]] - [https://resources.apollolims.com/blog/covid-19-testing-and-the-important-role-of-a-lims Apollo LIMS for COVID-19]
* [[Vendor:Comp Pro Med, Inc.|Comp Pro Med, Inc.]] - [https://www.comppromed.com/covid-19-rapid-deployment-lis/ COVID-19 Rapid Deployment LIS]
* [[Vendor:Illumina, Inc.|Illumina, Inc.]] - [https://blog.software.illumina.com/2020/04/14/efficient-accurate-lab-management-for-covid-19-research/ BaseSpace Clarity LIMS for COVID-19]
* [[Vendor:Junction Concepts, Inc.|Junction Concepts, Inc.]] - [https://qbench.net/qbench-covid-19-lims-laboratory-information-management-system/ QBench]
* [[Vendor:LabLynx, Inc.|LabLynx, Inc.]] - [https://www.covidlims.com/ COVIDLiMS]
* [[Vendor:LabVantage Solutions, Inc.|LabVantage Solutions, Inc.]] - [https://www.labvantage.com/your-lab-type/labvantage-covid-19-lims/ LabVantage COVID-19 LIMS]
* [[Vendor:Physion, LLC|Physion, LLC]] - [https://www.ovation.io/covid-19/ Ovation LIMS for COVID-19]
* [[Vendor:Sunquest Information Systems, Inc.]] - [https://www.sunquestinfo.com/docs/sunquest-covid19-mitogen-lims-product-focus.pdf Mitogen LIMS for COVID-19] (PDF)
* [[Vendor:Third Wave Analytics, Inc.|Third Wave Analytics, Inc.]] - [https://thirdwaveanalytics.com/covid19/ Lockbox LIMS for SARS-CoV-2 Clinical Testing]

Additionally, when in-house knowledge is lacking, a consultant may be required. These consultants are meant to be representative examples of those laboratory consulting firms indicating they have the knowledge to help a laboratory with COVID-19-related testing and other issues. This list is not an endorsement for any particular consultant:

* [https://www.aruplab.com/consulting ARUP Laboratories] (Utah)
* [https://www.colaborate.com/covid-19-lab-consulting/ Colaborate] (Florida)
* [https://elitediagnostics.com/verticals/infectious-disease/ Elite Diagnostics] (North Carolina)
* [https://www.freedassociates.com/news/freed-associates-launches-a-covid-19-consulting-service-for-health-care-organizations/ Freed Associates] (California)
* [https://www.lighthouselabservices.com/consulting/infectious-disease/ Lighthouse Lab Services] (North Carolina)
* [https://optimumhit.com/ehr-services/covid-19-support/ Optimum Healthcare IT] (Florida)
* [https://thecovidconsultants.com/ The COVID Consultants] (Colorado)
* [https://www.triumvirate.com/coronavirus Triumverate Environmental] (Massachusetts)