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^6}9_]w)!phxR:^c]rcS0>Vd/BoE?/+;#WC{--h:#9i0G#sunGzGzGzGzGzAP0C3P0C3TfYaVfYaVfYaVfYaVfYaVP1C_WfS46`36`36`36`36`36l 5: Nl 5 flu~w~w~w~w~plW %l+cP9 jj|O9,MU7^S8u_ss!Sx >stream 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 Catalog No. When available, the number of samples used for sensitivity/specificity definitions are listed in the product description. For information on serology (antibody) tests, visit our serology tracker or visit our report outlining the needs of a national serology strategy. Please use the form below to provide feedback related to the content on this product. Rapid Diagnostic Testing for Influenza: Information for Clinical This page was last updated on March 30, 2022. 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). Before Developed with RADx support by San Diego-based diagnostic company Quidel, this test is easily performed with a nasal swab and offers results in just 10 minutes. 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. 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. Included and available for separate purchase, Electrophoresis, Western Blotting and ELISA, Chromatography and Mass Spectrometry Reagents, Laboratory Syringe Needles and Accessories, Lab Coats, Aprons, and Other Safety Apparel, Sharps Disposal Containers and Accessories, Classroom Laboratory Supplies and Consumables, Applied Biosystems TaqMan Assay and Arrays Search Tool, Applied Biosystems TaqMan Custom Assay Design Tools, Applied Biosystems Custom qPCR Primers and TaqMan Probes Tool, Chemical Storage and Management Resource Center. PMC 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. Validation of an At-Home Direct Antigen Rapid Test for COVID-19 H\n@b"20K DbRKXYp/J"^b?)]M>^}1]/c1u}1_kw0e>]tKZGx[xcz,ocPO:~ A highly specific test should rule out all true negative results. endstream endobj 1736 0 obj <. 2021 May 22;20(1):38. doi: 10.1186/s12941-021-00443-w. Chaimayo C, Kaewnaphan B, Tanlieng N, Athipanyasilp N, Sirijatuphat R, Chayakulkeeree M, Angkasekwinai N, Sutthent R, Puangpunngam N, Tharmviboonsri T, Pongraweewan O, Chuthapisith S, Sirivatanauksorn Y, Kantakamalakul W, Horthongkham N. Virol J. %%EOF The authors declare no conflict of interest. Finally, Quidel QuickVue touts an 83 . The agency said early results suggest that antigen tests "do detect the omicron variant but may have reduced sensitivity," meaning it's possible the tests could miss an infection, known as a . 0Q0QQ(\&X The fastest test being used to diagnose people infected with the coronavirus appears to be the least accurate test now in common use, according to new research obtained by NPR. Specificity of available antibody tests may vary by assay; it is important to check the validation data provided by the manufacturer and/or performing laboratory. 10.1128/JCM.00938-20 There was no statistically valid correlation between the semi-quantitative PCR result and the QuickVue result. hb```@(e# Because the sensitivity of the test is 97, of these about 48 will be labeled as positive, and the remaining 2 will not be correctly detected. Effectiveness and cost-effectiveness of four different strategies for SARS-CoV-2 surveillance in the general population (CoV-Surv Study): a structured summary of a study protocol for a cluster-randomised, two-factorial controlled trial. sharing sensitive information, make sure youre on a federal Download the complete list of commercial tests (xlsx). Our aim was to determine the real-life clinical sensitivity of SARS-CoV-2 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. Selection of the outpatient cohort presented as a flowchart. Cochrane Database Syst Rev. This site is relatively easily accessed, compared to the final site of viral infection: the lower respiratory tract. While government employees, students and the general public had to wait in line for hours in the beginning of the pandemic, at-home test kits make it easy to diagnose for the novel coronavirus in less than 30 minutes. At-Home OTC COVID-19 Diagnostic Tests | FDA hbbd```b``kz -. Copyright var today=new Date(); document.write(today.getFullYear()); | Web Policies, Common types of antigen and molecular tests being developed for SARS-CoV-2. 2022 Oct 27;19(21):14011. doi: 10.3390/ijerph192114011. endstream endobj 1773 0 obj <>/Metadata 142 0 R/Outlines 202 0 R/Pages 1768 0 R/StructTreeRoot 258 0 R/Type/Catalog>> endobj 1774 0 obj <>/ExtGState<>/Font<>/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 1775 0 obj <>stream May 27;58(8):938. HHS Vulnerability Disclosure, Help 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. The QuickVue At-Home OTC COVID-19 Test is a lateral flow immunoassay, with results readable by eye. Study Raises Questions About False Negatives From Quick COVID-19 Test Dan Med J 68:A03210217. The QuickVue SARS Antigen Test is authorized for use on anterior nares (NS) swab specimens directly from . Performance of an Antigen-Based Test for How accurate are at-home COVID-19 tests? | wcnc.com How do molecular tests detect SARS-CoV-2? Federal government websites often end in .gov or .mil. 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. Medical articles on testing. This site needs JavaScript to work properly. The . about 48, will return positive. 2021 Feb 9;11(2):e047110. 2021 May 18;12(3):e00902-21. PMC $2,262.00 / Case of 10 PK. Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ), BioGX SARS-CoV-2 Reagents for BD MAX System, ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RTqPCR) Detection Kit, Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing), COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit, FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR), Jiangsu Bioperfectus Technologies Co., Ltd, RTA Laboratories Biological Products Pharmaceutical and Machinery Industry, Gravity Diagnostics SARS-CoV-2 RT-PCR Assay, DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit, QuantiVirus SARS-CoV-2 Multiplex Test Kit, Gnomegen COVID-19 RT-Digital PCR Detection Kit, Logix Smart Coronavirus Disease 2019 (COVID-19) Kit, New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel, Quest COVID-19 PCR Test Home Collection Kit, Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2, STS Lab Holdco (a subsidiary of Amazon.com Services LLC), Color SARS-CoV-2 RT-LAMP Diagnostic Assay, The Color COVID-19 Self-Swab Collection Kit, Color COVID-19 Self-Swab Collection Kit with Saline, Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test, Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2, Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test, STS Lab Holdco (a subsidiary of Amazon.com Services LLC, RCA Laboratory Services LLC dba GENETWORx, Laboratory Corporation of America (Labcorp), Life Sciences Testing Center COVID-19 Test, Yale School of Public Health, Department of Epidemiology of Microbial Diseases, Kwokman Diagnostics COVID-19 Home Collection Kit, The Mount Sinai Hospital, Center for Clinical Laboratories, binx health At-Home Nasal Swab COVID-19 Sample Collection Kit, Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute, Everlywell COVID-19 & Flu Test Home Collection Kit, Harvard University Clinical Laboratory (HUCL), Pinpoint by Phosphorus COVID-19 Test Home Collection Kit DTC, Laboratory Corporation of America (LabCorp), Kaiser Permanente High Throughput SARS-CoV-2 Assay, Southern California Permanente Medical Group, Clinical Enterprise SARS-CoV-2 RT-PCR Assay, Clinical Enterprise SARS-CoV-2 RT-PCR Assay DTC, University of Illinois Office of the Vice President for Economic Development and Innovation, ResearchDx, Inc., DBA Pacific Diagnostics, Infinity BiologiX TaqPath SARS-CoV-2 Assay, Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits, CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay, Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard, Kroger Health COVID-19 Test Home Collection Kit, Everlywell COVID-19 Test Home Collection Kit DTC, Quest Diagnostics RC COVID-19 +Flu RT-PCR, Quest Diagnostics Infectious Disease, Inc, Stanford Health Care Clinical Virology Laboratory, UCLA SwabSeq COVID-19 Diagnostic Platform, University of California, Los Angeles (UCLA), Cuur Diagnostics SARS-CoV-2 Molecular Assay, Akron Childrens Hospital SARS-Cov-2 Assay, Acupath COVID-19 Real-Time (RT-PCR) Assay, Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay, Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay, Texas Department of State Health Services, Laboratory Services Section, Alpha Genomix TaqPath SARS-CoV-2 Combo Assay, George Washington University Public Health Laboratory, University of California San Diego Health, SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay, Compass Laboratory Services SARS-CoV2 Assay, UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin, Laboratorio Clinico Toledo SARS-CoV-2 Assay, LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel, Inform Diagnostics SARS-CoV-2 RT-PCR Assay, MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay, University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory, HealthQuest Esoterics TaqPath SARS-CoV-2 Assay, The Ohio State University Wexner Medical Center, Omnipathology Solutions Medical Corporation, Express Gene 2019-nCoV RT-PCR Diagnostic Panel, Express Gene LLC, DBA: Express Gene Molecular Diagnostics Laboratory, Avera Institute for Human Genetics SARS-CoV-2 Assay, One Health Laboratories SARS-CoV-2 Real-Time RT-PCR Test, Columbia University Laboratory of Personalized Genomic Medicine, Biocollections Worldwide SARS-Co-V-2 Assay, Southwest Regional PCR Laboratory LLC. Rusanen J, Kareinen L, Szirovicza L, Uurlu H, Levanov L, Jskelinen A, Ahava M, Kurkela S, Saksela K, Hedman K, Vapalahti O, Hepojoki J. mBio. 3`EJ|_(>]3tzxyyy4[g `S~[R) QuickVue SARS Antigen Test Page 1 of 15 For use under the Emergency Use Authorization (EUA) only . 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. Sensitivity was dependent upon the CT value for each sampling method. Sensitivity Specificity COVID-19 At-Home Test SD Biosensor, Inc. lateral flow immunoassay ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) Siemens Healthcare Diagnostics, Inc. . =gd(u\ VXto!7m Please sign in to view account pricing and product availability. Rapid SARS-CoV-2 tests can be run immediately as needed. Healthcare professionals can purchase the QuickVue SARS Antigen Test through select authorized distributors. *Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. Similarly, $(1-a)P$ will be infected but test negative. 2022 Nov 18;19(1):191. doi: 10.1186/s12985-022-01922-y. How Accurate Are At-Home Covid Tests? Here's a Quick Guide That makes $aP + (1-b)(N-P)$ in total who test positive. How Accurate Are COVID-19 Tests? Many Factors Can Affect Sensitivity Essentially, a lower limit of detection indicates a more sensitive test, with fewer viral copies per sample necessary to elicit a positive test result. Many of these are somewhat technical, but still readable. J Mol Diagn. Available from, Kucharski AJ, Klepac P, Conlan A, Kissler SM, Tang M, Fry H, et al.. FAQ: What you need to know about the new DIY COVID-19 antigen - CNA Included in the complete list are sensitivity and specificity measures, specimens required, target genes, test details, and manufacturing capabilities (if provided). Unauthorized use of these marks is strictly prohibited. This website is not intended to be used as a reference for funding or grant proposals. 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. Would you like email updates of new search results? n?=0 !=GBGKdD&lchl(Ct)!$qV618rey\5x| A diagnostic accuracy study comparing RNA LAMP, direct LAMP, and rapid antigen testing from nasopharyngeal swabs. f Dinnes J, Deeks JJ, Berhane S, Taylor M, Adriano A, Davenport C, Dittrich S, Emperador D, Takwoingi Y, Cunningham J, Beese S, Domen J, Dretzke J, Ferrante di Ruffano L, Harris IM, Price MJ, Taylor-Phillips S, Hooft L, Leeflang MM, McInnes MD, Spijker R, Van den Bruel A; Cochrane COVID-19 Diagnostic Test Accuracy Group. 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 . NAATs include thepolymerase chain reaction (PCR) assay in a laboratory to amplify viral genomic material for detection and can provide results in hours to days; other techniques include LAMP and next generation sequencing. Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in - PubMed -, Moore NM, Li H, Schejbal D, Lindsley J, Hayden MK. Among 1,732 paired samples from asymptomatic patients, the antigen test sensitivity was 60.5%, and specificity was 99.5% when compared with RT-PCR. PCR; SARS-CoV-2; infectious disease; rapid antigen detection; sensitivity; specificity; swabbing; test performance. . While PCR-tests are usually considered as the gold standard to detect infection with the SARS-CoV-2 coronavirus in terms of sensitivity as well as specificity, antigen tests (Ag-Tests) offer practical advantages in terms of costs, logistics and speed [].Because Ag-Tests may play a major role in large scale testing strategies [2, 3] in populations with low prevalence, besides . Bookshelf Quidel says its COVID-19 antigen test is now on par with PCR accuracy The diagnostic testing field for COVID-19 is rapidly evolving, with many tests focused on diagnosing patients with active viral infections. Unauthorized use of these marks is strictly prohibited. MAUDE Adverse Event Report: QUIDEL CORPORATION QUICKVUE AT-HOME OTC official website and that any information you provide is encrypted Background: How accurate are rapid antigen tests for diagnosing COVID-19? With the underlying study, the head-to-head test performance and the usability of self-collected samples for SARS-CoV-2 detection using rapid antigen detection devices were evaluated. Participant flowchart. RIDTs are not recommended for use in hospitalized patients with suspected . We appreciate your feedback. -, Altamirano J, Govindarajan P, Blomkalns AL, Kushner LE, Stevens BA, Pinsky BA, Maldonado Y. An official website of the United States government. Rapid tests can help you stay safe in the Delta outbreak. PDF Comparison of the ID NOW and Accula Point-of-Care Assays for the A positive test result for COVID-19 indicates that For optimal browsing, we recommend Chrome, Firefox or Safari browsers. December 2022 Rapid antigen tests offer a quick and easy way to screen for COVID-19 on your own. Where available, we list the manufacturer-reported sensitivity and specificity data. Guidance for Antigen Testing for SARS-CoV-2 for Healthcare Providers 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. December 1,;15(12 December):e0242958. Int J Environ Res Public Health. How Not to Use a Rapid, At-Home Coronavirus Test - The Atlantic Analysis of the specificity of a COVID-19 antigen test in the Slovak For antibody tests, it is the ability to identify samples where no SARS-CoV-2 antibodies are present. 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. 2023;12(1):6. doi: 10.1186/s43088-023-00342-3. In people with confirmed COVID-19, antigen tests correctly identified COVID-19 infection in an average of 73% of people with symptoms, compared to 55% of people without symptoms. There are $N - P$ who are not infected, and of these the tests of $b(N-P)$ will return negative. But you have to use them correctly. 2023 Feb 3;23(1):240. doi: 10.1186/s12889-023-15036-9. We analyzed date of onset and symptoms using data from a clinical questionnaire. 23-044-167. 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. 0 Chaimayo C, Kaewnaphan B, Tanlieng N, Athipanyasilp N, Sirijatuphat R, Chayakulkeeree M, Angkasekwinai N, Sutthent R, Puangpunngam N, Tharmviboonsri T, Pongraweewan O, Chuthapisith S, Sirivatanauksorn Y, Kantakamalakul W, Horthongkham N. Virol J. Conclusions: The clinical sensitivity of SARS-CoV-2 RT-PCR testing was only moderate at best. Testing among symptomatic participants indicated the following for the BinaxNOW antigen test (with real-time RT-PCR as the standard): sensitivity, 64.2%; specificity, 100%; PPV, 100%; and NPV, 91.2% ( Table 2 ); among asymptomatic persons, sensitivity was 35.8%; specificity, 99.8%; PPV, 91.7%; and NPV, 96.9%. At-Home COVID-19 Test Kit Page 2 of 14 The QuickVue At-Home COVID -19 Test is intended for self-use and/or, as applicable for an adult lay user testing another person aged 8 years or older in a . 10.1016/j.jmoldx.2021.01.005 National Library of Medicine Antigen and Molecular Tests for COVID-19 The diagnostic testing field for COVID-19 is rapidly evolving, with many tests focused on diagnosing patients with active viral infections. If individuals who have the condition are considered "positive" and those who don't are considered "negative", then sensitivity is a measure of how well a test can identify true positives and specificity is a measure of how well a test can identify true negatives: QuickVue SARS Antigen Test | Quidel 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. Blue control line and red test line. Antigen and Molecular Tests for COVID-19 - COVID-19 Testing Toolkit FOIA Please enable it to take advantage of the complete set of features! hVmoH+U7B%$-(puA]F>wFcpq Wp|q.,RKvG!gD|Hw:+~BwYtprp5Dh7.{5o^LtA.zw;JXg7cZ~?OKGFq\NW|:3:KwUYV3mh? Then of our 1000, 200 will be infected. Home COVID Tests: Accuracy, Where to Buy, & Supply Issues - Intelligencer (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. Index tests were treated as inconclusive if the test line of the RAD tests was barely discernible. 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. This does not alter our adherence to PLOS ONE policies on sharing data and materials. . The QuickVue SARS Antigen Test provides accurate and reliable results in 10 minutes. The site is secure. Bookshelf %PDF-1.5 % All contact information provided shall also be maintained in accordance with our In general, ARTs can achieve a sensitivity of about 80 per cent for cases with higher viral loads and a specificity range of 97 to 100 per cent, said HSA. FDA says rapid Covid antigen tests may be less sensitive in detecting Fig 1. Epub 2023 Feb 8. The sensitivity and the specifity of rapid antigen test in Results: Sensitivity of the QuickVue was found to be 27% in this sample. Room temperature (15C to 30C/59F to 86F). Careers. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 2022 Feb 23;10(1):e0245521. Initial versions were claimed to possess a sensitivity of around 80%, but more recent ones are claimed to have about 97% sensitivity, which is certainly comparable with PCR tests. However, the reliability of the tests depends largely on the test performance and the respective sampling method. Interpreting a covid-19 test result | The BMJ Some of these at-home tests require a prescription or telehealth monitoring. SARS-CoV-2 infection status was confirmed by RT-PCR. doi: 10.1002/14651858.CD013705. Available RIDTS detect and differentiate between type influenza A and B viruses, but do not specifically identify or differentiate subtypes of influenza A viruses. Where government is going in states & localities. How Reliable Are Covid-19 Rapid Tests for Detecting Omicron? What are sensitivity and specificity? | Evidence-Based Nursing 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%. Please enable it to take advantage of the complete set of features! 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). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. endstream endobj startxref doi: 10.1128/mBio.00902-21. 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. So in this case, when the proportion of the overall population who are infected is rather small, the test is swamped by false positives. hbbd```b``1A$" 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.