Participants self-performed one oral and one anterior nasal swab for the rapid antigen test, immediately followed by two nasopharyngeal swabs for the rapid antigen test and RT-PCR by the investigator. Fig 3. https://www.who.int/publications/i/item/overview-of-public-health-and-so WHO Overview of public health and social measures in the context of COVID-19. Definitely not to be ignored. Sensitivity and specificity are measures that are critical for all diagnostic tests. Participant flowchart. In addition, there will be 990 who are not infected, and 5% or about 49 of these will test as positive, making a total of 58. declared that COVID -19 was a pandemic on March 11, 2020, and . Sensitivity and Specificity of SARS-CoV-2 Rapid Antigen Detection Tests For the QuickVue rapid test the sensitivity was 8.5% (4.8-13.7%, 95% CI) and specificity was 99.2% (95.6-100%, 95% CI). Selection of the inpatient cohort. j=S+wE-V`~;j`E'w=YX2xx[tdQR8*Bx"y5HMeM(362-*4CmV3aM$ YE`&zVY9{t~ 0 q0 We analyzed date of onset and symptoms using data from a clinical questionnaire. See this image and copyright information in PMC. Epub 2022 Feb 16. Antigen tests detect specific viral proteins (antigens) present in a patient sample taken using nasal or nasopharyngeal swabs and can provide results in under a half hour. Due to product restrictions, please Sign In to purchase or view availability for this product. Background: These tests require samples from the patient that are likely to contain virus. Kn8/#eoh6=*c^tXpy! The test is called the QuickVue At-Home COVID-19 Test. Where can I go for updates and more information? The clinical sensitivity of SARS-CoV-2 RT-PCR testing was only moderate at best. The FDA is committed to providing as many bulk testing options to the public by quickly approving a number of at-home tests, starting with. Your feedback has been submitted. Noninclusion in this list should not be interpreted as a judgment on the validity or legitimacy of tests. Indirect Virus Transmission via Fomites Can Counteract Lock-Down Effectiveness. Cao G, Lin K, Ai J, Cai J, Zhang H, Yu Y, Liu Q, Zhang X, Zhang Y, Fu Z, Song J, Wang H, Yuan G, Wang S, Guan M, Zhang W. Front Microbiol. Rapid Diagnostic Testing for Influenza: Information for Clinical Xie JW, Zheng YW, Wang M, Lin Y, He Y, Lin LR. Get smart with Governing. 0 2020. They also claimed from the start a specificity of 100%. Evaluation of Abbott BinaxNOW Rapid Antigen Test for SARS-CoV-2 2021;23(4):407416. Dive Brief: Quidel Corporation shared new data late Friday showing its COVID-19 antigen test has 96.7% sensitivity within five days of the onset of patient symptoms. So in this case, when the proportion of the overall population who are infected is rather small, the test is swamped by false positives. H\n0E|"Z EJVbj2CV4H_|nrG}.56e>\Yo)wq?onp Ofus'pk1\>/{y7ncp|L32Mu Finally, Quidel QuickVue touts an 83 . All rights reserved. 2023 All rights reserved. -, Arevalo-Rodriguez I, Buitrago-Garcia D, Simancas-Racines D, Zambrano-Achig P, Campo RD, Ciapponi A, et al.. False-negative results of initial RT-PCR assays for COVID-19: A systematic review. Quidel QuickVue At-Home COVID-19 Test. Test results and respective RT-PCR C T value for (A), MeSH Patriquin G, LeBlanc JJ, Williams C, Hatchette TF, Ross J, Barrett L, Davidson R. Microbiol Spectr. Test parameters were calculated based on the evaluation of 87 participants. Clinical Evaluation of Roche SD Biosensor Rapid Antigen Test for SARS %PDF-1.6 % and transmitted securely. %PDF-1.5 % Website Terms of Use Privacy Policy EEA Privacy Policy AdvaMed Code of Ethics Site Map, PPA (Reference Extracted SARS-CoV-2 RT-PCR Assay), NPA (Reference Extracted SARS-CoV-2 RT-PCR Assay), Product documentation is best viewed in Internet Explorer, General Information - Coronavirus (COVID-19), Additional Information - Quidel's EUA COVID-19 Products, Quick Reference Instructions - English - CE, Technical Bulletin - Antigen vs. Antibody Testing, Technical Bulletin - Detection of SARS-CoV-2 and SARS-CoV, Package Insert - CE -Latin American Spanish. Travel Med Infect Dis. If a diagnostic test correctly identified 100% of all positive results, it would be as sensitive as possible. 145 0 obj <>/Filter/FlateDecode/ID[<7B25B64DC0023C44A3787FE5A23F64CA>]/Index[107 67]/Info 106 0 R/Length 158/Prev 133259/Root 108 0 R/Size 174/Type/XRef/W[1 3 1]>>stream JAMA Netw Open 3:e2012005. How Reliable Are Covid-19 Rapid Tests for Detecting Omicron? %%EOF At-home covid tests: What to know - The Washington Post We rapid-tested a sample onsite and compared results with those from reverse transcription PCR and virus culture. 2021 Jun 15;31(2):020601. doi: 10.11613/BM.2021.020601. Available RIDTS detect and differentiate between type influenza A and B viruses, but do not specifically identify or differentiate subtypes of influenza A viruses. Current status of the lateral flow immunoassay for the detection of SARS-CoV-2 in nasopharyngeal swabs. Before GK Pharmaceuticals Contract Manufacturing Operations, Primerdesign Ltd COVID-19 genesig Real-Time PCR assay, Infectious Diseases Diagnostics Laboratory (IDDL), Boston Childrens Hospital, Northwestern Diagnostic Molecular Laboratory, Understanding the Accuracy of Diagnostic and Serology Tests: Sensitivity and Specificity. A Generic, Scalable, and Rapid Time-Resolved Frster Resonance Energy Transfer-Based Assay for Antigen Detection-SARS-CoV-2 as a Proof of Concept. PMC The QuickVue At-Home COVID-19 Test is a type of test called an antigen test. Cost: $23.99 for two tests. f3jE|@$\0[,, Ln`-"=Ig vF3f!`{+@$Y o#&FjF p Fisher Scientific is always working to improve our content for you. endstream endobj 1776 0 obj <>stream QuickVue At-Home COVID-19 Test - Instructions for Use Public health officials are urging Americans to get tested before traveling or gathering with friends and family members, citing rapid tests as an important tool for curbing a variant that is. There are now several studies assessing their accuracy but as yet no systematic . QuickVue SARS Antigen Test. Specificity is calculated based on how many people do not have the disease. Specificity is the ability of the test to identify those the true negatives. The QuickVue SARS Antigen Test provides accurate and reliable results in 10 minutes, allowing for COVID-19 testing of symptomatic patients within the first five days of symptoms and asymptomatic patients when tested serially. There are $N - P$ who are not infected, and of these the tests of $b(N-P)$ will return negative. YHUZeo{.ecYU`bG &%o/r4$.%2Kf1s|_K'{d]tptptpTZ%DM&t nB7M&t)s9E2GQ(s9sl`W_~UvV`Ae=(z0`lp6:glp6:g|_'>th1c1. hVmoH+U7B%$-(puA]F>wFcpq Wp|q.,RKvG!gD|Hw:+~BwYtprp5Dh7.{5o^LtA.zw;JXg7cZ~?OKGFq\NW|:3:KwUYV3mh? Included in the complete list are sensitivity and specificity measures, specimens required, target genes, test details, and manufacturing capabilities (if provided). An official website of the United States government. Sensitivity Specificity COVID-19 At-Home Test SD Biosensor, Inc. lateral flow immunoassay ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) Siemens Healthcare Diagnostics, Inc. . Some of the at-home rapid antigen tests have an overall sensitivity of roughly 85 percent, which means that they are catching roughly 85 percent of people who are infected with the virus and. 2020 Nov 13;17(1):177. doi: 10.1186/s12985-020-01452-5. Index tests were treated as inconclusive if the test line of the RAD tests was barely discernible. Antigen and Molecular Tests for COVID-19 - COVID-19 Testing Toolkit CDC: Looking at these three examples it seems that the test becomes more accurate as the overall probability of infection increases. That makes another 48, and a total of 93 positive test results. Copyright var today=new Date(); document.write(today.getFullYear()); | Web Policies, Common types of antigen and molecular tests being developed for SARS-CoV-2. Antigens are found on the surface of the virus particle, which are also shed in patient tissues. endstream endobj 1777 0 obj <>stream 10.1016/S1473-3099(20)30457-6 MAUDE Adverse Event Report: QUIDEL CORPORATION QUICKVUE AT-HOME OTC Sensitivity refers to the test's. This study shows the poor sensitivity of AT in asymptomatic subjects, specificity being however excellent. Fig 2. Many of these are somewhat technical, but still readable. Keywords: Results: Sensitivity of the QuickVue was found to be 27% in this sample. The FDA also authorized the Quidel QuickVue coronavirus test, which delivers results in 10 minutes and also can be used without a prescription. These measures are not independently validated by the Johns Hopkins Center for Health Security. 10.1128/JCM.00938-20 Given the data in hand, it makes sense to say that the probability he is one of the infected is 45/93 = 0.49 or 49%. Cochrane Database Syst Rev 3:Cd013705. Conclusions: The clinical sensitivity of SARS-CoV-2 RT-PCR testing was only moderate at best. Selection of the outpatient cohort. Quidel Corporation Disease 2019 QuickVue At-Home COVID-19 Test March 1 Of these, 95% = 9 will test positive. Comparison between Nasal and Nasopharyngeal Swabs for SARS-CoV-2 Rapid Antigen Detection in an Asymptomatic Population, and Direct Confirmation by RT-PCR from the Residual Buffer. endstream endobj startxref December 1,;15(12 December):e0242958. No instrument necessary. The overall sensitivity of rapid antigen detection tests versus that of RT-PCR with oral, anterior nasal, and nasopharyngeal samples was 18.18% (95% confidence interval [CI] 8.19% to 32.71%), 63.04% (95% CI 47.55% to 76.79%), and 73.33% (95% CI 58.06% to 85.4%), respectively. doi: 10.1136/bmjopen-2020-047110. Complications of nasal and pharyngeal swabs: a relevant challenge of the COVID-19 pandemic? The. Now the probability that the Governor is infected would be 180/220 = 82%, much higher than before. Simple workflow follows a similar format to CLIA-waived QuickVue assays. Additional Information - Quidel's EUA COVID-19 Products (Scroll down to the list of EUA products and enter Quidel in the search box). XLSX Johns Hopkins Center for Health Security COVID-19 tests and test systems used for diagnostic or screening testing, including those for antigen testing, must have received an EUA from FDA or be offered under the policies in FDA's Policy for COVID-19 Tests. FDA authorizes two rapid COVID-19 home tests made by Abbott and Quidel Clipboard, Search History, and several other advanced features are temporarily unavailable. December 2022 Rapid antigen tests offer a quick and easy way to screen for COVID-19 on your own. Disclaimer. While the main advantage of rapid antigen detection tests is the immediate availability of results, PCR should be preferred in crucial settings wherever possible. High false-negative rate limits value of rapid COVID tests for kids -, Altamirano J, Govindarajan P, Blomkalns AL, Kushner LE, Stevens BA, Pinsky BA, Maldonado Y. 10.1016/j.jmoldx.2021.01.005 Quidel QuickVue Test The company says positive results with the Quidel QuickVue test agree with PCR tests 83.5% of the time and that negative results agree 99.2% of the time. government site. Of these, 95% = 180 will test positive. Where to purchase: Amazon, CVS, HEB Pharmacy, Hy-Vee, Optum, Pharmacy and Wellness Center, Simply Medical, Tops, Walmart . 50]P]&Ljn00a@fb` 9!f 9 endstream endobj startxref Adults who were clinically suspected of SARS-CoV-2 infection and underwent SARS-CoV-2 RT-PCR testing, with sufficient data in their medical records for grading of clinical suspicion were eligible. hb```MRw@( 8 G@*YPFYl&SCsw /gjVWNQ}i7S8+tG V[jnd&u|W AO(>92H ":::b ,@61@L t9J$a`f7dfcbys s;:=Wnbwg7MdH2p > miH00DYw ee 5Lk+ Sensitivity is calculated based on how many people have the disease (not the whole population). . Home Immunoassays Strep QuickVue Dipstick Strep A Test Please enable it to take advantage of the complete set of features! and transmitted securely. Sensitivity measures how often a test correctly generates a positive result for the condition being tested. Yet recent studies raise questions about the tests'. f A positive test result for COVID-19 indicates that Sensitivity and specificity - Wikipedia uyratmP >NhHl'SlYb@~G C,l.H8Xh/2 My|PP#ZQ ,eH/dx+ P/b::@\A &"`^X(DZDAX `CA[tv@sx$A1%S:;6k5S1=3,`gs4n;!%&e&ywaqR K |{Q~MRx/(f0 5HL Available from, Kucharski AJ, Klepac P, Conlan A, Kissler SM, Tang M, Fry H, et al.. COVID Test Data - Rutgers As the manufacturer, SD Biosensor, transitions to this new brand,. No need to wait for reagents to warm up. Essentially, a lower limit of detection indicates a more sensitive test, with fewer viral copies per sample necessary to elicit a positive test result. For diagnostic tests, it is the ability to identify those samples which are not infected with SARS-CoV-2. Epub 2023 Jan 11. 2021 Jan 8;22(1):39. doi: 10.1186/s13063-020-04982-z. endstream endobj startxref How Accurate Are At-Home Covid Tests? Here's a Quick Guide In mid-June, Joanna Dreifus hit a pandemic . This page was last updated on March 30, 2022. Low impact of regular PCR testing on presence at work site during the COVID-19 pandemic: experiences during an open observational study in Lower Saxony 2020-21. If you have 100. (a Siemens Healthineers Company), BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay, Cue COVID-19 Test for Home and Over The Counter (OTC) Use, Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit, Visby Medical COVID-19 Point of Care Test, Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2, Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit, Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay, Centers for Disease Control and Prevention (CDC), Materials and Machines Corporation of America (DBA MatmaCorp, Inc.), SARS-CoV-2 RNA, Qualitative Real-Time RT-PCR. Included in the complete list are sensitivity and specificity measures, specimens required, target genes, and test details. Then $aP$ of these will be infected and test positive. 2023 Feb 3;23(1):240. doi: 10.1186/s12889-023-15036-9. If sensitivity or specificity is not listed, it was not available from the manufacturer at the time of posting. This site needs JavaScript to work properly. How accurate are at-home COVID-19 tests? | wcnc.com hb```@(e# 1799 0 obj <>/Filter/FlateDecode/ID[<10A139E46589C743805C124A9AB3B57B><371A73E9AEDB34478DBF012D63C79AC6>]/Index[1772 41]/Info 1771 0 R/Length 126/Prev 905933/Root 1773 0 R/Size 1813/Type/XRef/W[1 3 1]>>stream Before blaming SARS-CoV-2 for venous sinus thrombosis in a septic patient, consider alternative etiologies. Therefore, with these values of sensitivity and specificity, a nominal 48 will be found to be infected, and $850 + 2$ uninfected. FAQ: What you need to know about the new DIY COVID-19 antigen - CNA Somborac Baura A, Doroti M, Groi L, Dimbeg M, Dodig S. Biochem Med (Zagreb). Of the 370 COVID-19 diagnostic tests that the US Food and Drug Administration has authorized for emergency use in the US, there are dozens you can take at home. Wang Y, Li X, Wang Y, Tu Z, Xu J, Pan J, Zhou Q. Virol J. Epub 2023 Feb 8. How Accurate Are COVID-19 Tests? Many Factors Can Affect Sensitivity Dinnes J, Deeks JJ, Adriano A, Berhane S, Davenport C, Dittrich S, Emperador D, Takwoingi Y, Cunningham J, Beese S, Dretzke J, Ferrante di Ruffano L, Harris IM, Price MJ, Taylor-Phillips S, Hooft L, Leeflang MM, Spijker R, Van den Bruel A; Cochrane COVID-19 Diagnostic Test Accuracy Group. Guidance for Antigen Testing for SARS-CoV-2 for Healthcare Providers We will not share your information for any other purposes. %%EOF Would you like email updates of new search results? 2023 Feb 9;52:102548. doi: 10.1016/j.tmaid.2023.102548. endstream endobj 1736 0 obj <. The QuickVue SARS Antigen Test provides accurate and reliable results in 10 minutes, allowing for COVID-19 testing of symptomatic patients within the first five days of symptoms and asymptomatic patients when tested serially. The ratio $p = P/N$ is the proportion of infected in the general population. Selection of the outpatient cohort presented as a flowchart. Results: Comparison of two commercial platforms and a laboratory developed test for detection of SARS-CoV-2 RNA. Please sign in to view account pricing and product availability. Effectiveness of isolation, testing, contact tracing and physical distancing on reducing transmission of SARS-CoV-2 in different settings. %PDF-1.5 % COVID epidemiology explained: sensitivity and specificity Our aim was to determine the real-life clinical sensitivity of SARS-CoV-2 RT-PCR. Dr. Keklinen reports a lecture honorarium from MSD. Unauthorized use of these marks is strictly prohibited. Sample Size and Duration of Study: The aim is to test 100 unique patients. Rapid SARS-CoV-2 antigen detection assay in comparison with real-time RT-PCR assay for laboratory diagnosis of COVID-19 in Thailand. government site. Diagnostic Performance of an Antigen Test A highly specific test should rule out all true negative results. False-negative RT-PCR for COVID-19 and a diagnostic risk score: a retrospective cohort study among patients admitted to hospital. Supplier: Quidel 20387. Accessibility For diseases that are primarily respiratory in nature, like COVID-19, nasopharyngeal swabs have been the most reliable, as they sample an area of the respiratory tract where the virus appears to first infect an individual. H\j@zY& s?}* it`Tn}M'w6pKMtxbrmLWs/4UuJwic|,omK'pk)R_Ktitk=>Fi6^X="5pSQbO%~!7 xKw~'g3#3#+'{dtptptp:\a W+ Study Raises Questions About False Negatives From Quick COVID-19 Test For reference, WHO and FDA performance standards for rapid antigen tests specify a minimum sensitivity of 80% and a minimum specificity of 97%. Federal government websites often end in .gov or .mil. For information on serology (antibody) tests, visit our serology tracker or visit our report outlining the needs of a national serology strategy. Chen GJ, Palmer JRB, Bartumeus F, Alba-Casals A. Infect Dis Model. For specimens collected within 5 days of reported symptom onset (72.4%; 152 of 210), sensitivity was 74.2% (23 of 31), and specificity was 99.2% (120 of 121). Similarly, $(1-a)P$ will be infected but test negative. Would you like email updates of new search results? For optimal browsing, we recommend Chrome, Firefox or Safari browsers. The nasopharyngeal tract likely has (1) active virus replication and (2) enough virus to be detected in test kits. Shafie MH, Antony Dass M, Ahmad Shaberi HS, Zafarina Z. Beni Suef Univ J Basic Appl Sci. This site needs JavaScript to work properly. Diagnostics able to detect current, active infections are typically antigen- and molecular-based tests. The US FDA recommends that manufacturers use these terms to indicate that a nonreference standard was used when evaluating the test. Wu S, Shi X, Chen Q, Jiang Y, Zuo L, Wang L, Jiang M, Lin Y, Fang S, Peng B, Wu W, Liu H, Zhang R, Kwan PSL, Hu Q. Ann Clin Microbiol Antimicrob. Karlafti E, Tsavdaris D, Kotzakioulafi E, Kaiafa G, Savopoulos C, Netta S, Michalopoulos A, Paramythiotis D. Life (Basel). The ratio $q = (N-P)/N$ is the proportion of uninfected. Accuracy and cost description of rapid antigen test compared with reverse transcriptase-polymerase chain reaction for SARS-CoV-2 detection. 23-044-167. Sensitivity vs. specificity: The eternal AI debate - MedCity News 2023 Feb 3:acsinfecdis.2c00472. Specificity in COVID-19 testing - Siemens Healthineers hbbd```b``1A$" The relatively high false negative rates of SARS-CoV-2 RT-PCR testing need to be accounted for in clinical decision making, epidemiological interpretations, and when using RT-PCR as a reference for other tests. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). endstream endobj 1778 0 obj <>stream Among 871 paired specimens from asymptomatic participants, 21 (2.4%) were antigen-positive and 17 (2.0%) were real-time RT-PCR-positive. Healthcare professionals can purchase the QuickVue SARS Antigen Test through select authorized distributors. Quidel says its COVID-19 antigen test is now on par with PCR accuracy Specificity, on the other hand, measures a test's ability to correctly generate a negative result for people who do not have the condition being tested . The site is secure. We appreciate your feedback. Sensitivity of rapid antigen testing and RT-PCR performed on nasopharyngeal swabs versus saliva samples in COVID-19 hospitalized patients: results of a prospective comparative trial (RESTART). When also patients that were graded as high suspicion but never tested positive were included in the denominator, the sensitivity (95% CI) was: 67.5% (62.9-71.9%) inpatients; 34.9% (31.4-38.5%) outpatients; 47.3% (44.4-50.3%) all. ]bqi"w8=8YWf8}3aK txg^+v!a{Bhk 5YliFeT?}YV-xBmN(}H)&,# o0 H\n@b"20K DbRKXYp/J"^b?)]M>^}1]/c1u}1_kw0e>]tKZGx[xcz,ocPO:~ e.Republic LLC, Abbott BinaxNow COVID-19 Antigen Self Tests, California Residents - Do Not Sell My Personal Information. The objective of our study was to evaluate the sensitivity and specificity of rapid antigen detection tests versus those of reverse transcriptase PCR (RT-PCR) using oral, anterior nasal, and nasopharyngeal swabs. PDF Comparison of the ID NOW and Accula Point-of-Care Assays for the The QuickVue At-Home OTC COVID-19 Test is a lateral flow immunoassay, with results readable by eye. HHS Vulnerability Disclosure, Help I have read the journals policy and the authors of this manuscript have the following competing interests: Dr. Kortela reports non-financial support from MSD, outside the submitted work. That makes $aP + (1-b)(N-P)$ in total who test positive. 10.1371/journal.pone.0242958 The . SARS-CoV-2 infection status was confirmed by RT-PCR. Background Lateral flow devices (LFDs) are viral antigen tests for the detection of SARS-CoV-2 that produce a rapid result, are inexpensive and easy to operate. The diagnostic testing field for COVID-19 is rapidly evolving, with many tests focused on diagnosing patients with active viral infections. Rapid antigen detection tests using self-collected anterior nasal swabs proved to be as sensitive as and more tolerable than professionally collected nasopharyngeal swabs for CT values up to 30 determined by RT-PCR. 858.552.1100 Tel 858.453.4338 Fax -. Often called "rapid tests" or "home COVID tests," these rapid antigen tests rely on a. Rapid SARS-CoV-2 tests can be run immediately as needed. These tests inform researchers and health providers of the presence of the pathogen, either by amplifying and detecting its genetic material or identifying unique markers of the pathogen itself. How Accurate Are At-Home Rapid Covid Tests - Which to Buy - Men's Health 6 The use of repeat RT-PCR testing as gold standard is likely to underestimate the true rate of false negatives, as not all patients in `H/`LlX}&UK&_| _`t@ 2021. 1812 0 obj <>stream J Mol Diagn. Interpreting a covid-19 test result | The BMJ This study is consistent with the low sensitivity of the QuickVue test also reported by others. ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag), INDICAID COVID-19 Rapid Antigen At-Home Test, Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit, Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing), PerkinElmer New Coronavirus Nucleic Acid Detection Kit, CLINITEST Rapid COVID-19 Antigen Self-Test, MaximBio ClearDetect COVID-19 Antigen Home Test, PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1, BD Veritor System for Rapid Detection of SARS-CoV-2, VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack, Let's Get Checked Coronavirus (COVID-19) Test, Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.), CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, Centers for Disease Control and Prevention, WREN Laboratories COVID-19 Saliva Test Collection Kit DTC, Synergy Diagnostic Laboratory, Inc., DBA SynergyDx, Sienna-Clarity COVID-19 Antigen Rapid Test Cassette, Celltrion DiaTrust COVID-19 Ag Rapid Test, Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test, PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit, Fast Track Diagnostics Luxembourg S..r.l.
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