User:Shawndouglas/sandbox/sublevel1

From LIMSWiki
Jump to navigationJump to search
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 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[1]:

  1. Do your current and long-term needs require basic PCR systems, qPCR systems, or digital PCR systems?
  2. What sample formats do you anticipate using?
  3. What throughput requirements do you have now and anticipate in the near future?
  4. What are you willing to sacrifice in regards to temperature ramp up and cool down times and accuracies?
  5. 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.[2]

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 FDA website. However, sorting through the extra details can be tedious. The Center for Systems Biology at Harvard has been maintaining a 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.[3] 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.[4] 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.[5][6][7] 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."[8]

Table 1. CLIA-waived COVID-19-related in vitro molecular diagnostic tests (e.g., RT-PCR, LAMP, isothermal amplification) receiving U.S. FDA Emergency Use Authorizations (EUAs)
First date EUA issued Manufacturer Name of test or assay Required instrument Technology (Method) Multi-analyte? RADx-funded? Approved for at-home? Additional comments
20 March 2020 Cepheid Xpert Xpress SARS-CoV-2 test GeneXpert Xpress System (Tablet and Hub Configurations) Molecular (RT-PCR) No No No Has largely received positive review of sensitivity and specificity.[9][10][11]
23 March 2020 Mesa Biotech Inc. Accula SARS-CoV-2 test Accula Dock or the Sekisui Diagnostics Silaris Dock (discontinued) Molecular (RT-PCR) No Yes No Has received only minor scrutiny[12], with only several dozen FDA complaints/reports[13]
27 March 2020 Abbott Diagnostics Scarborough, Inc. ID NOW COVID-19 ID NOW Molecular (isothermal amplification) No No No Targets "a unique region of the RNA-dependent RNA polymerase (RdRP) gene."[14]Device and test were target of FDA scrutiny due to sensitivity issues reported in 2020 and into 2021[15][16][17][18] 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.[19] 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.[20] On August 27, 2021, the FDA re-issued its EUA for the ID NOW with updated in silico inclusivity analysis results (among other things)[21], but it's not clear if the FDA is continuing to work with Abbott on the test's accuracy claims.
10 June 2020 Cue Health Inc. Cue COVID-19 Test Cartridge Cue Health Monitoring System Molecular (isothermal amplification) No No No "Test primers amplify the nucleocapsid (N) region of the gene"[22]
14 September 2020 Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B Assay cobas Liat PCR System Molecular (RT-PCR) Yes No No Everitt et al. offer some discussion and citations concerning research related to the cobas LIAT PCR system and its assays.[23]
24 September 2020 Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV test GeneXpert Xpress System (Tablet and Hub Configurations) Molecular (RT-PCR) Yes No No Development of this multiplex assay for SARS-CoV-2, Flu A, Flu B, and RSV was announced in June 2020.[24] After receiving its EUA in September 2020, received advanced development support through the Department of Health and Human Services and the Department of Defense.[25]
02 October 2020 BioFire Diagnostics, LLC BioFire Respiratory 2.1 (RP2.1) Panel BioFire FilmArray Systems Molecular (RT-PCR) Yes No No From the manufacturer: "The BioFire RP2.1 Panel (EUA) detects 22 respiratory pathogens, including SARS-CoV-2, to help clinicians quickly rule in and rule out common causes of respiratory illness in about 45 minutes."[26] 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."[27]
17 November 2020 Lucira Health, Inc. Lucira COVID-19 All-In-One Test Kit N/A Molecular (RT-LAMP) No No Yes First complete at-home COVID test kit receiving EUA. For CLIA-waived labs and prescription at-home use. Test device is apparently one-time-use and not reusable.[28]
27 November 2020 Cepheid Xpert Omni SARS-CoV-2 test GeneXpert Omni System Molecular (RT-PCR) No No No For CLIA-waived testing, the test is limited to nasopharyngeal, anterior nasal, or mid-turbinate swab specimens.[29] Product status unclear, as it was listed on website in January 2021[30], but not listed there as of September 2021.
08 February 2021 Visby Medical, Inc. Visby Medical COVID-19 Point of Care Test N/A Molecular (RT-PCR) No Yes No "By shrinking rapid PCR technology to palm-sized dimensions and eliminating the need for an additional instrument or reader, Visby Medical’s test provides fast, accurate, and actionable results at the point of need."[31]
05 March 2021 Cue Health Inc. Cue COVID-19 Test for Home and Over The Counter Use Cue Health Monitoring System Molecular (isothermal amplification) No No Yes Described as "the nation’s first molecular diagnostic test available without a prescription to consumers for home use and to enterprise users and healthcare professionals without CLIA certification."[32] It is also able to be used for screening purposes.
09 April 2021 Lucira Health, Inc. Lucira CHECK-IT COVID-19 Test Kit N/A Molecular (RT-LAMP) No No Yes Appears to be an over-the-counter (vs. prescription) version of its Lucira COVID-19 All-In-One Test Kit from November 2020. Also able to be used for screening.
17 June 2021 Roche Molecular Systems, Inc. cobas SARS-CoV-2 Assay cobas Liat PCR System Molecular (RT-PCR) No No No Appears to be similar to its multi-analyte product from 2020 but solely for COVID-19, and also able to be used for screening.[33]
N/A (Anticipated) Talis Biomedical Talis One Cartridge Talis One Instrument Molecular (RT-LAMP) No Yes To be determined Expectations are that it will receive an FDA EUA and be CLIA-waived[34], but yet to be determined. As of August 2021, it was still awaiting FDA authorization.[35]
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
First date EUA issued Manufacturer Name of test or assay Required instrument Technology (Method) Multi-analyte? RADx-funded? Approved for at-home? Additional comments
08 May 2020 Quidel Corporation Sofia SARS Antigen FIA Sofia 2 Antigen (Lateral flow) No Yes No SARS-CoV-2 Sensitivity (PPA): 96.7%; SARS-CoV-2 Specificity (NPA): 100%[36]
02 July 2020 Becton, Dickinson and Company BD Veritor System for Rapid Detection of SARS-CoV-2 BD Veritor Plus Antigen (Immunoassay) No No No SARS-CoV-2 Sensitivity (PPA): 83.9%; SARS-CoV-2 Specificity (NPA): 100%[8]
18 August 2020 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 Ag Test LumiraDx Platform Antigen (Microfluidic) No No No SARS-CoV-2 Sensitivity (PPA): 97.6%; SARS-CoV-2 Specificity (NPA): 96.6%.[37] As of September 2021, at least one performance evaluation study is in-process.[38]
26 August 2020 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag Card NAVICA mobile system Antigen (Lateral flow) No No No SARS-CoV-2 Sensitivity (PPA): 84.6%; SARS-CoV-2 Specificity (NPA): 98.5%[39]
02 October 2020 Quidel Corporation Sofia 2 Flu + SARS Antigen FIA Sofia 2 Antigen (Lateral flow) Yes Yes No SARS-CoV-2 Sensitivity (PPA): 95.2%; SARS-CoV-2 Specificity (NPA): 100%[40]
08 October 2020 Access Bio, Inc. CareStart COVID-19 Antigen N/A Antigen (Lateral flow) No No No SARS-CoV-2 Sensitivity (PPA): 90.47%; SARS-CoV-2 Specificity (NPA): 99.66% (Note: average of swab types)[41]
07 December 2020 Luminostics, Inc. Clip COVID Rapid Antigen Test Clip Analyzer (PDF) Antigen (Lateral flow) No Yes No SARS-CoV-2 Sensitivity (PPA): 96.9%; SARS-CoV-2 Specificity (NPA): 100%[42]
15 December 2020 Ellume Limited Ellume COVID-19 Home Test A mobile phone that supports their app Antigen (Lateral flow) No Yes Yes (OTC) SARS-CoV-2 Sensitivity (PPA): 94.6%; SARS-CoV-2 Specificity (NPA): 96.9%[43]
16 December 2020 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag Card Home Test A mobile phone that supports their NAVICA app Antigen (Lateral flow) No No Yes (Prescription) SARS-CoV-2 Sensitivity (PPA): 91.7%; SARS-CoV-2 Specificity (NPA): 100%[44]
18 December 2020 Quidel Corporation QuickVue SARS Antigen Test N/A Antigen (Lateral flow) No No No SARS-CoV-2 Sensitivity (PPA): 96.6%; SARS-CoV-2 Specificity (NPA): 99.3%[45]
04 February 2021 Princeton BioMeditech Corp. Status COVID-19/Flu A&B N/A Antigen (Lateral flow) Yes No No SARS-CoV-2 Sensitivity (PPA): 93.9%; SARS-CoV-2 Specificity (NPA): 100%[46]
01 March 2021 Quidel Corporation QuickVue At-Home COVID-19 Test N/A Antigen (Lateral flow) No No Yes (Prescription) SARS-CoV-2 Sensitivity (PPA): 84.8%; SARS-CoV-2 Specificity (NPA): 99.1%[47]
31 March 2021 Quidel Corporation QuickVue At-Home OTC COVID-19 Test N/A Antigen (Lateral flow) No No Yes (OTC) SARS-CoV-2 Sensitivity (PPA): 83.5%; SARS-CoV-2 Specificity (NPA): 99.2%[48]
31 March 2021 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag Card 2 Home Test N/A Antigen (Lateral flow) No No Yes SARS-CoV-2 Sensitivity (PPA): 91.7%; SARS-CoV-2 Specificity (NPA): 100%[49]
16 April 2021 Celltrion USA, Inc. Celltrion DiaTrust COVID-19 Ag Rapid Test N/A Antigen (Lateral flow) No No No SARS-CoV-2 Sensitivity (PPA): 93.33%; SARS-CoV-2 Specificity (NPA): 99.03%[50]
06 May 2021 InBios International, Inc. SCoV-2 Ag Detect Rapid Test N/A Antigen (Lateral flow) No No No SARS-CoV-2 Sensitivity (PPA): 86.67%; SARS-CoV-2 Specificity (NPA): 100%[51]
20 May 2021 Salofa Oy Sienna-Clarity COVID-19 Antigen Rapid Test Cassette N/A Antigen (Lateral flow) No No No SARS-CoV-2 Relative Sensitivity: 87.5%; SARS-CoV-2 Relative Specificity: 98.9% (note that it's relative)[52]
04 June 2021 OraSure Technologies, Inc. InteliSwab COVID-19 Rapid Test N/A Antigen (Lateral flow) No No Yes (OTC) SARS-CoV-2 Sensitivity (PPA): 84.3%; SARS-CoV-2 Specificity (NPA): 97.9%[53]
04 June 2021 OraSure Technologies, Inc. InteliSwab COVID-19 Rapid Test Rx N/A Antigen (Lateral flow) No No Yes (Prescription) SARS-CoV-2 Sensitivity (PPA): 84.3%; SARS-CoV-2 Specificity (NPA): 97.9%[54]
04 June 2021 OraSure Technologies, Inc. InteliSwab COVID-19 Rapid Test Pro N/A Antigen (Lateral flow) No No No SARS-CoV-2 Sensitivity (PPA): 84.3%; SARS-CoV-2 Specificity (NPA): 97.9%[55]
08 July 2021 Ellume Limited ellume.lab COVID Antigen Test ellume.lab digital device Antigen (Lateral flow) No Yes No SARS-CoV-2 Sensitivity (PPA): 81.8%; SARS-CoV-2 Specificity (NPA): 100%[56]
13 July 2021 GenBody Inc. GenBody COVID-19 Ag N/A Antigen (Lateral flow) No No No SARS-CoV-2 Sensitivity (PPA): 96.0%; SARS-CoV-2 Specificity (NPA): 99.28%[57]
28 July 2021 PHASE Scientific International, Ltd. INDICAID COVID-19 Rapid Antigen Test N/A Antigen (Lateral flow) No No No SARS-CoV-2 Sensitivity (PPA): 84.4%; SARS-CoV-2 Specificity (NPA): 96.6% (average of health-care-provider-collected and self-collected)[58]
02 August 2021 Access Bio, Inc. CareStart COVID-19 Antigen Home Test (Not on website yet) N/A Antigen (Lateral flow) No No Yes (OTC) SARS-CoV-2 Sensitivity (PPA): 86.6%; SARS-CoV-2 Specificity (NPA): 97.6% (Note: average of swab types)[59]
24 August 2021 Becton, Dickinson and Company BD Veritor At-Home COVID-19 Test (Not on website yet) N/A Antigen (Lateral flow) No No Yes SARS-CoV-2 Sensitivity (PPA): 84.6%; SARS-CoV-2 Specificity (NPA): 99.8%[60]

References

  1. ↑ Kerkhof, J. (13 June 2018). "PCR Equipment Survey Results". Lab Manager. https://www.labmanager.com/surveys/what-to-look-for-in-a-pcr-system-2154. Retrieved 14 August 2020. 
  2. ↑ Lab Manager (7 April 2020). "Results from the Lab Manager Life Science Technology Survey". Lab Manager. https://www.labmanager.com/surveys/results-from-the-lab-manager-life-science-technology-survey-22257. Retrieved 14 August 2020. 
  3. ↑ Thi, V.L.D.; Herbst, K.; Boerner, K. et al. (2020). "A colorimetric RT-LAMP assay and LAMP-sequencing for detecting SARS-CoV-2 RNA in clinical samples". Science Translational Medicine: eabc7075. doi:10.1126/scitranslmed.abc7075. PMID 32719001. 
  4. ↑ "Alethia". Meridian Bioscience. https://www.meridianbioscience.com/platform/molecular/alethia/. Retrieved 14 August 2020. 
  5. ↑ Service, R.F. (2020). "Radical shift in COVID-19 testing needed to reopen schools and businesses, researchers say". Science. doi:10.1126/science.abe1546. 
  6. ↑ Guglielmi, G. (2020). "The explosion of new coronavirus tests that could help to end the pandemic". Nature 583: 506–09. doi:10.1038/d41586-020-02140-8. 
  7. ↑ Taylor, N.P. (4 November 2020). "FDA warns of COVID-19 antigen test false positives as report flags Quidel on accuracy". MedTechDive. https://www.medtechdive.com/news/fda-warns-of-covid-19-antigen-test-false-positives-as-report-flags-quidel-o/588349/. Retrieved 20 November 2020. 
  8. ↑ 8.0 8.1 "Veritor System For Rapid Detection of SARS-CoV-2" (PDF). Becton, Dickinson and Company. January 2021. https://bdveritor.bd.com/content/dam/bdveritor/pdfs/BD-Veritor-IFU.pdf. Retrieved 09 September 2021. 
  9. ↑ Moran, A.; Beavis, K.G.; Matushek, S.M. et al. (2020). "Detection of SARS-CoV-2 by Use of the Cepheid Xpert Xpress SARS-CoV-2 and Roche cobas SARS-CoV-2 Assays". Journal of Clinical Microbiology 58 (8): e00772-20. doi:10.1128/JCM.01072-20. PMC PMC7383516. PMID 32303565. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7383516. 
  10. ↑ Loeffelholz, M.J.; Alland, D.; Butler-Wu, S.M. et al. (2020). "Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test". Journal of Clinical Microbiology 58 (8): e00926-20. doi:10.1128/JCM.00926-20. PMC PMC7383535. PMID 32366669. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7383535. 
  11. ↑ Goldenberger, D.; Leusinger, K.; Sogaard, K.K. et al. (2020). "Brief validation of the novel GeneXpert Xpress SARS-CoV-2 PCR assay". Journal of Virological Methods 284: 113925. doi:10.1016/j.jviromet.2020.113925. PMC PMC7351036. PMID 32659240. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7351036. 
  12. ↑ Hogan, C.A.; Garamani, N.; Lee, A.S. et al. (2020). "Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens". Journal of Clinical Microbiology 58 (8): e01072-20. doi:10.1128/JCM.01072-20. PMC PMC7383558. PMID 32461285. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7383558. 
  13. ↑ "MAUDE - Manufacturer and User Facility Device Experience". U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm. Retrieved 08 September 2021. "Search for "Accula" in Brand Name" 
  14. ↑ Ravi, N.; Cortade, D.L.; Ng, E. et al. (2020). "Diagnostics for SARS-CoV-2 detection: A comprehensive review of the FDA-EUA COVID-19 testing landscape". Biosensors and Bioelectronics 165: 112454. doi:10.1016/j.bios.2020.112454. PMC PMC7368663. PMID 32729549. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7368663. 
  15. ↑ Devine, C. (3 July 2020). "Coronavirus test used by White House has questionable accuracy". CNN Politics. https://www.cnn.com/2020/07/03/politics/coronavirus-white-house-test-abbott/index.html. Retrieved 08 July 2020. 
  16. ↑ Perrone, M. (14 May 2020). "FDA probes accuracy issue with Abbott’s rapid virus test". Associated Press. https://apnews.com/c8ab010e8e02dfe7beb34a5e5df11279. Retrieved 19 May 2020. 
  17. ↑ Basu, A.; Zinger, T.; Inglima, K. et al. (2020). "Performance of Abbott ID Now COVID-19 Rapid Nucleic Acid Amplification Test Using Nasopharyngeal Swabs Transported in Viral Transport Media and Dry Nasal Swabs in a New York City Academic Institution". Journal of Clinical Microbiology 58 (8): e01136-20. doi:10.1128/JCM.01136-20. PMC PMC7383552. PMID 32471894. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7383552. 
  18. ↑ Mitchell, S.L.; St. George, K. (2020). "Evaluation of the COVID19 ID NOW EUA assay". Journal of Clinical Virology 128: 104429. doi:10.1016/j.jcv.2020.104429. PMC PMC7227587. PMID 32425657. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7227587. 
  19. ↑ Taylor, N.P. (7 October 2020). "Abbott, on defense, details embattled rapid COVID-19 test results". MedTechDive. https://www.medtechdive.com/news/abbott-on-defense-id-now-coronavirus-test-postmarket-study/586579/. Retrieved 18 November 2020. 
  20. ↑ "MAUDE - Manufacturer and User Facility Device Experience". U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm. Retrieved 07 September 2021. "Search for "ID NOW COVID-19" in Brand Name" 
  21. ↑ Hinton, D.M. (27 August 2021). "ID NOW COVID-19" (PDF). U.S. Food and Drug Administration. https://www.fda.gov/media/136522/download. Retrieved 07 September 2021. 
  22. ↑ "Cue COVID-19 Test Instructions for Use" (PDF). Cue Health, Inc. 26 March 2021. https://www.fda.gov/media/138826/download. Retrieved 08 September 2021. 
  23. ↑ Everitt, M.L.; Tillery, A.; David, M.G. et al. (2020). "A critical review of point-of-care diagnostic technologies to combat viral pandemics". Analytica Chimica Acta In Press. doi:10.1016/j.aca.2020.10.009. PMC PMC7548029. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7548029. 
  24. ↑ Cepheid (9 June 2020). "Cepheid Announces Development of Four-in-One Combination Test for SARS-CoV-2, Flu A, Flu B and RSV". PR Newswire. https://www.prnewswire.com/news-releases/cepheid-announces-development-of-four-in-one-combination-test-for-sars-cov-2-flu-a-flu-b-and-rsv-301072489.html. Retrieved 13 August 2020. 
  25. ↑ Global Biodefense Staff (8 October 2020). "BARDA and JPEO-CBRND Back Cepheid’s Multiplex Test for Influenza, SARS-CoV2 and RSV". Global Biodefense. https://globalbiodefense.com/2020/10/08/barda-and-jpeo-cbrnd-back-cepheids-multiplex-test-for-flu-rsv-and-sars-cov2/. Retrieved 19 November 2020. 
  26. ↑ [https://www.biofiredx.com/covid-19/ "BioFire’s Respiratory Solutions with SARS-CoV-2"]. BioFire Diagnostics, LLC. https://www.biofiredx.com/covid-19/. Retrieved 19 November 2020. 
  27. ↑ Creager, H.M.; Cabrera, B.; Schnaubelt, A. et al. (2020). "Clinical evaluation of the BioFire Respiratory Panel 2.1 and detection of SARS-CoV-2". Journal of Clinical Virology 129: 104538. doi:10.1016/j.jcv.2020.104538. PMC PMC7336953. PMID 32650276. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7336953. 
  28. ↑ "Lucira Health COVID-19 All-In-One Test Kit". Lucira Health, Inc. 2020. https://www.fda.gov/media/143809/download. Retrieved 20 November 2020. 
  29. ↑ "Xpert Omni SARS-CoV-2" (PDF). Cepheid. April 2021. https://www.fda.gov/media/144033/download. Retrieved 08 September 2021. 
  30. ↑ "Introducing the GeneXpert Omni". Cepheid. Archived from the original on 23 January 2021. https://web.archive.org/web/20210123173157/https://www.cepheid.com/en_US/systems/GeneXpert-Family-of-Systems/GeneXpert-Omni. Retrieved 08 September 2021. 
  31. ↑ "Visby Medical’s COVID-19 PCR Point of Care Test Authorized for Use in CLIA Waived Settings". Visby Medical, Inc. 2 February 2021. https://www.visbymedical.com/news/press-release-visby-medical-covid-19-pcr-point-of-care-test-authorized-for-use-in-clia-waived-settings. Retrieved 08 September 2021. 
  32. ↑ "Cue’s COVID‑19 Diagnostic Test". Cue Health, Inc. https://www.cuehealth.com/products/how-cue-detects-covid-19/. Retrieved 08 September 2021. 
  33. ↑ "cobas SARS-CoV-2". Roche Molecular Systems, Inc. December 2020. https://www.fda.gov/media/150278/download. Retrieved 08 September 2021. 
  34. ↑ "Talis One Molecular Testing". Talis Biomedical. https://talisbio.com/talis-one-covid-19-assay/. Retrieved 08 September 2021. 
  35. ↑ O'Connor, L. (11 August 2021). "Despite MDx Product Delays, Talis Biomedical Expecting 'Meaningful Revenue Ramp in 2022'". 360 Dx. Archived from the original on 11 August 2021. https://web.archive.org/web/20210811210316/https://www.360dx.com/business-news/despite-mdx-product-delays-talis-biomedical-expecting-meaningful-revenue-ramp-2022. Retrieved 07 September 2021. 
  36. ↑ "Sofia SARS Antigen FIA". Quidel Corporation. https://www.quidel.com/immunoassays/rapid-sars-tests/sofia-sars-antigen-fia. Retrieved 09 September 2021. 
  37. ↑ "COVID-19 SARS-CoV-2 Antigen Test". LumiraDx UK Ltd. https://www.lumiradx.com/us-en/what-we-do/diagnostics/test-technology/antigen-test. Retrieved 09 September 2021. 
  38. ↑ "Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag Test (ASPIRE)". ClinicalTrials.gov. National Institutes of Health. 22 October 2020. https://clinicaltrials.gov/ct2/show/NCT04557046. 
  39. ↑ "BinaxNOW COVID-19 Ag CARD" (PDF). Abbott Diagnostics Scarborough, Inc. December 2020. https://www.fda.gov/media/141570/download. Retrieved 09 September 2021. 
  40. ↑ "Sofia 2 Flu + SARS Antigen FIA". Quidel Corporation. https://www.quidel.com/immunoassays/sofia-2-flu-sars-antigen-fia. Retrieved 09 September 2021. 
  41. ↑ "CareStart COVID-19 Antigen". Access Bio, Inc. https://accessbiodiagnostics.net/carestart-covid-19-antigen/. Retrieved 09 September 2021. 
  42. ↑ "Clip COVID Rapid Antigen Test" (PDF). Luminostics, Inc. 2021. https://lib.umso.co/lib_XCpfHrGtBDMqBGId/rphccfc1jrh5j5yz.pdf. Retrieved 09 September 2021. 
  43. ↑ "Ellume COVID-19 Home Test" (PDF). Ellume Limited. https://www.fda.gov/media/144592/download. Retrieved 09 September 2021. 
  44. ↑ "BinaxNOW COVID-19 Ag Card Home Test" (PDF). Abbott Diagnostics Scarborough, Inc. March 2021. https://www.fda.gov/media/144574/download. Retrieved 09 September 2021. 
  45. ↑ "QuickVue SARS Antigen Test". Quidel Corporation. https://www.quidel.com/immunoassays/quickvue-sars-antigen-test. Retrieved 09 September 2021. 
  46. ↑ "Status COVID-19/Flu A&B - Rapid SARS-CoV-2/Influenza A+B Antigen Panel Test". Princeton BioMeditech Corp. http://www.pbmc.com/products/covid.shtm. Retrieved 09 September 2021. 
  47. ↑ "QuickVue At-Home COVID-19 Test" (PDF). Quidel Corporation. 2021. https://www.fda.gov/media/146312/download. Retrieved 09 September 2021. 
  48. ↑ "QuickVue At-Home OTC COVID-19 Test" (PDF). Quidel Corporation. May 2021. https://quickvueathome.com/wp-content/uploads/2021/08/EF1500200EN00.pdf. Retrieved 09 September 2021. 
  49. ↑ "BinaxNOW COVID-19 Ag Card 2 Home Test" (PDF). Abbott Diagnostics Scarborough, Inc. March 2021. https://www.fda.gov/media/147259/download. Retrieved 09 September 2021. 
  50. ↑ "Celltrion DiaTrust COVID-19 Ag Rapid Test". Celltrion USA, Inc. https://www.celltrion.com/en-us/kit/DiatrustAg. Retrieved 09 September 2021. 
  51. ↑ "SCoV-2 Ag Detect Rapid Test". InBios International, Inc. https://inbios.com/scov-2-ag-detecttm-rapid-test/. Retrieved 09 September 2021. 
  52. ↑ "Sienna-Clarity COVID-19 Antigen Rapid Test Cassette" (PDF). Salofa Oy. https://www.fda.gov/media/149055/download. Retrieved 09 September 2021. 
  53. ↑ "InteliSwab COVID-19 Rapid Test" (PDF). OraSure Technologies, Inc. https://www.fda.gov/media/149911/download. Retrieved 09 September 2021. 
  54. ↑ "InteliSwab COVID-19 Rapid Test Pro Rx" (PDF). OraSure Technologies, Inc. https://www.fda.gov/media/149906/download. Retrieved 09 September 2021. 
  55. ↑ "InteliSwab COVID-19 Rapid Test Pro" (PDF). OraSure Technologies, Inc. https://inteliswab.com/wp-content/uploads/2021/08/3001-3455-0521-COVID-19-Rapid-Test-Pro-IFU_2.pdf. Retrieved 09 September 2021. 
  56. ↑ "ellume·lab COVID Antigen Instructions for Use" (PDF). Ellume Limited. https://www.fda.gov/media/150687/download. Retrieved 09 September 2021. 
  57. ↑ "COVID-19 Ag". GenBody Inc. http://genbody.co.kr/bbs/board.php?bo_table=human01&wr_id=22. Retrieved 09 September 2021. 
  58. ↑ "INDICAID COVID-19 Rapid Antigen Test" (PDF). PHASE Scientific International, Ltd.. July 2021. https://us.phasescientific.com/wp-content/uploads/2021/08/05a_eua210259.phase-indicaid-ag.IFU-07-28-2021.pdf. Retrieved 09 September 2021. 
  59. ↑ "CareStart COVID-19 Antigen Home Test". Access Bio, Inc. 2 August 2021. https://www.fda.gov/media/151248/download. Retrieved 09 September 2021. 
  60. ↑ "BD Veritor At-Home COVID-19 Test" (PDF). ecton, Dickinson and Company. July 2021. https://www.fda.gov/media/151761/download. Retrieved 09 September 2021. 
Retrieved from "https://www.limswiki.org/index.php?title=User:Shawndouglas/sandbox/sublevel1&oldid=46062"