This site is relatively easily accessed, compared to the final site of viral infection: the lower respiratory tract. e.Republic LLC, Abbott BinaxNow COVID-19 Antigen Self Tests, California Residents - Do Not Sell My Personal Information. 1772 0 obj <>stream Xie JW, Zheng YW, Wang M, Lin Y, He Y, Lin LR. 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. Antigens are found on the surface of the virus particle, which are also shed in patient tissues. In addition to examining the first RT-PCR test of repeat-tested individuals, we also used high clinical suspicion for COVID-19 as the reference standard for calculating the sensitivity of SARS-CoV-2 RT-PCR. 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). Easy to read and interpret. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. 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. Wang Y, Li X, Wang Y, Tu Z, Xu J, Pan J, Zhou Q. Virol J. CDC: 0 See this image and copyright information in PMC. Sensitivity refers to the test's. Cochrane Database Syst Rev. . 2021. 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. Antigen tests are designed to detect proteins from the virus that causes COVID-19, in anterior nasal swabs. eCollection 2022. The ratio $q = (N-P)/N$ is the proportion of uninfected. -, Jakobsen KK, Jensen JS, Todsen T, Tolsgaard MG, Kirkby N, Lippert F, Vangsted AM, Martel CHM, Klokker M, von Buchwald C. 2021. Never miss a story with Governing's Daily newsletter. Catalog No. Sensitivity Specificity COVID-19 At-Home Test SD Biosensor, Inc. lateral flow immunoassay ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) Siemens Healthcare Diagnostics, Inc. . In this experiment, Governor DeWine is one of 93, of whom 45 are infected, 48 not. vefA3uH!8UEk56.Vie=i$| 9X4^#@gFpW5x2(70A]:ZMSl endstream endobj 108 0 obj <. 10.1128/JCM.00938-20 Some of these at-home tests require a prescription or telehealth monitoring. Accessibility n?=0 !=GBGKdD&lchl(Ct)!$qV618rey\5x| The US FDA recommends that manufacturers use these terms to indicate that a nonreference standard was used when evaluating the test. The .gov means its official. 2021 Feb 9;11(2):e047110. Medical articles on testing. Fig 1. JAMA Netw Open 3:e2012005. PCR; SARS-CoV-2; infectious disease; rapid antigen detection; sensitivity; specificity; swabbing; test performance. 10.1016/j.jmoldx.2021.01.005 The fast-spreading Omicron variant has made us increasingly reliant on at-home rapid antigen tests to tell us whether we have Covid-19. Sensitivity and specificity are measures that are critical for all diagnostic tests. endstream endobj startxref Gupta-Wright A, Macleod CK, Barrett J, Filson SA, Corrah T, Parris V, Sandhu G, Harris M, Tennant R, Vaid N, Takata J, Duraisingham S, Gandy N, Chana H, Whittington A, McGregor A, Papineni P. BMJ Open. 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%. 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. However, the reliability of the tests depends largely on the test performance and the respective sampling method. PMC 2022 Dec;7(4):811-822. doi: 10.1016/j.idm.2022.11.001. hbbd```b``l%vD2`& }fH=`X\v`,+fH`ld; + %%EOF 2023 Feb 3:acsinfecdis.2c00472. Epub 2022 Feb 16. 107 0 obj <> endobj Rapid SARS-CoV-2 antigen detection assay in comparison with real-time RT-PCR assay for laboratory diagnosis of COVID-19 in Thailand. 0 Before blaming SARS-CoV-2 for venous sinus thrombosis in a septic patient, consider alternative etiologies. 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. 173 0 obj <>stream Assessment of sensitivity and specificity of patient-collected lower nasal specimens for severe acute respiratory syndrome coronavirus 2 testing. Emergency Use Authorizations FOIA Seiler LK, Stolpe S, Stanislawski N, Stahl F, Witt M, Jonczyk R, Heiden S, Blume H, Kowall B, Blume C. BMC Public Health. 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: J Clin Microbiol 2020. Participant flowchart. Rapid SARS-CoV-2 tests can be run immediately as needed. Subject: qv otc consumer received false positive for 1st test; went to er room & reported pcr and antibody test as negative -- tss advised of qv otc sensitivity and specificity for positives and negatives; will log feedback for review and follow-up investigation conclusion: tested 5x retained devices with negative standard. The results confirm similar sensitivity of self-collected anterior nasal swabs to that of professionally collected nasopharyngeal swabs for patients with a CT of < 30 determined by RT-PCR. Conclusions: 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. %PDF-1.5 % Microorganisms 9:1910. doi:10.3390/microorganisms9091910. Specificity is compounded It may be helpful to define some terms here. Where to purchase: Amazon, CVS, HEB Pharmacy, Hy-Vee, Optum, Pharmacy and Wellness Center, Simply Medical, Tops, Walmart . Please sign in to view account pricing and product availability. 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. 2020 Nov 13;17(1):177. doi: 10.1186/s12985-020-01452-5. Clipboard, Search History, and several other advanced features are temporarily unavailable. Int J Environ Res Public Health. 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 duration of this study will be determined based upon the number of specimens collected daily. This work was supported by Academy of Finland (ELKE, grant no 308913) and Doctoral Programme in Biomedicine, Faculty of Medicine, University of Helsinki (SJ). official website and that any information you provide is encrypted This page was last updated on March 30, 2022. By clicking Submit, you acknowledge that you may be contacted by Fisher Scientific in regards to the feedback you have provided in this form. Disclaimer. The QuickVue SARS Antigen Test is authorized for use on anterior nares (NS) swab specimens directly from . 1812 0 obj <>stream 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. and transmitted securely. 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. Essentially, a lower limit of detection indicates a more sensitive test, with fewer viral copies per sample necessary to elicit a positive test result. There will still be 950 who are not infected, but 5% = (100 - 95)% of these, i.e. hb```f``tAX,- endstream endobj 1778 0 obj <>stream For diagnostic tests, it is the ability to identify those samples which are not infected with SARS-CoV-2. ; The results for the company's Sofia SARS Antigen FIA, which in May was the first such diagnostic to receive FDA emergency use authorization, are in line with the sensitivity rates of polymerase chain reaction (PCR) tests. Rapid SARS-CoV-2 antigen detection assay in comparison with real-time RT-PCR assay for laboratory diagnosis of COVID-19 in Thailand. There was no statistically valid correlation between the semi-quantitative PCR result and the QuickVue result. %%EOF These measures are not independently validated by the Johns Hopkins Center for Health Security. We have compiled a list of commercial and laboratory-developed tests that have received FDA Emergency Use Authorization. These tests require samples from the patient that are likely to contain virus. Now the probability that the Governor is infected would be 180/220 = 82%, much higher than before. hbbd```b``1A$" 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 . Brain Disord. The Diagnostic Accuracy of SARS-CoV-2 Nasal Rapid Antigen Self-Test: A Systematic Review and Meta-Analysis. f For reference, WHO and FDA performance standards for rapid antigen tests specify a minimum sensitivity of 80% and a minimum specificity of 97%. Where can I go for updates and more information? A positive test result for COVID-19 indicates that The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Healthcare professionals can purchase the QuickVue SARS Antigen Test through select authorized distributors. Selection of the outpatient cohort presented as a flowchart. Sensitivity is calculated based on how many people have the disease (not the whole population). hb```@(e# Then of our 1000, 10 will be infected. Diagnostics able to detect current, active infections are typically antigen- and molecular-based tests. 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. 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. 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. That makes $aP + (1-b)(N-P)$ in total who test positive. Selection of the inpatient cohort. %PDF-1.6 % How do molecular tests detect SARS-CoV-2? 2021. The terms sensitivity and specificity may not appear in the manufacturers information sheets, but are often reported as positive percent agreement and negative percent agreement. Sensitivity may also be measured by calculating the limit of detection, which is the lowest detectable number of virus copies in a sample at which the test will return a positive result at least 95% of the time. 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. The QuickVue SARS Antigen Test detects SARS-CoV-2 antigens directly from anterior nares swab specimens. 2022 Feb 23;10(1):e0245521. These rapid tests detect basic levels of antigen already present in a sample, providing only a simple yes or no, similar to a pregnancy test. Similarly, $(1-a)P$ will be infected but test negative. 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. As the manufacturer, SD Biosensor, transitions to this new brand,. The nasopharyngeal tract likely has (1) active virus replication and (2) enough virus to be detected in test kits. Sensitivity measures how often a test correctly generates a positive result for the condition being tested. 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. about 48, will return positive. Comparison of two commercial molecular tests and a laboratory-developed modification of the CDC 2019-nCoV RT-PCR assay for the detection of SARS-CoV-2. 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. 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. Detects SARS-CoV-2 antigens directly from anterior nares swab specimens. 2021;23(4):407416. Dr. Keklinen reports a lecture honorarium from MSD. $2,262.00 / Case of 10 PK. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Simple workflow follows a similar format to CLIA-waived QuickVue assays. 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. 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). We rapid-tested a sample onsite and compared results with those from reverse transcription PCR and virus culture. doi: 10.1021/acsinfecdis.2c00472. Your feedback has been submitted. -, Mannonen L, Kallio-Kokko H, Loginov R, Jskelinen A, Jokela P, Antikainen J, et al.. The ratio $p = P/N$ is the proportion of infected in the general population. The QuickVue SARS Antigen Test provides accurate and reliable results in 10 minutes. In the sample of 1000, there will be around 50 who are currently infected. 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. An official website of the United States government. endstream endobj 1777 0 obj <>stream -, Fh B, Borsche M, Balck A, Taube S, Rupp J, Klein C, Katalinic A. Please use the form below to provide feedback related to the content on this product. The clinical sensitivity of SARS-CoV-2 RT-PCR testing was only moderate at best. . 1772 0 obj <> endobj 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 . There are now several studies assessing their accuracy but as yet no systematic . Available from, Kucharski AJ, Klepac P, Conlan A, Kissler SM, Tang M, Fry H, et al.. The Wrong Way to Test Yourself for the Coronavirus. 8600 Rockville Pike This population-based retrospective study was conducted in March-April 2020 in the Helsinki Capital Region, Finland. 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. H\j@zY& s?}* it`Tn}M'w6pKMtxbrmLWs/4UuJwic|,omK'pk)R_Ktitk=>Fi6^X="5pSQbO%~!7 xKw~'g3#3#+'{dtptptp:\a W+ 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. 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 Complications of nasal and pharyngeal swabs: a relevant challenge of the COVID-19 pandemic? 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. Molecular tests called nucleic acid amplification tests (NAAT) rely on amplification of existing genetic material in the sample. Accuracy and cost description of rapid antigen test compared with reverse transcriptase-polymerase chain reaction for SARS-CoV-2 detection. The .gov means its official. 23-044-167. 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. All sampling methods had a test specificity of 100% regardless of the cycle threshold (CT) value. Effectiveness of isolation, testing, contact tracing and physical distancing on reducing transmission of SARS-CoV-2 in different settings. December 1,;15(12 December):e0242958. ea|/0`N=CTN~FR_" E&+'y+!*Q"i%z-i@C; eD2 @xyywp1HZ@ 1e`qAF^OLFl,,gr58x=S3d#J)q@xgmLc h,r 8Ag`[X 'X Quidel QuickVue At-Home COVID-19 At-Home Rapid Tests Sensitivity: 84.8% -PDF Specificity: 99.1% - PDF About iPromo iPromo, established 1999, is an award winning distributor of personal. Comparative evaluation of six nucleic acid amplification kits for SARS-CoV-2 RNA detection. Every antigen test for SARS-CoV-2 authorized for use by FDA is included on FDA's list of In Vitro Diagnostics EUAs. National Library of Medicine 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. -, Kritikos A, Caruana G, Brouillet R, Miroz J-P, Abed-Maillard S, Stieger G, Opota O, Croxatto A, Vollenweider P, Bart P-A, Chiche J-D, Greub G. 2021. Participant flowchart. Somborac Baura A, Doroti M, Groi L, Dimbeg M, Dodig S. Biochem Med (Zagreb). Available RIDTS detect and differentiate between type influenza A and B viruses, but do not specifically identify or differentiate subtypes of influenza A viruses. Test sensitivity indicates the ability of the test to correctly identify patients that have the disease. endstream endobj startxref j=S+wE-V`~;j`E'w=YX2xx[tdQR8*Bx"y5HMeM(362-*4CmV3aM$ YE`&zVY9{t~ 0 q0 Unauthorized use of these marks is strictly prohibited. Conclusions: The clinical sensitivity of SARS-CoV-2 RT-PCR testing was only moderate at best. FOIA 2021 Jun 15;31(2):020601. doi: 10.11613/BM.2021.020601. Background: Federal government websites often end in .gov or .mil. Overall test sensitivity was 84.9% (95% CI 79.1-89.4) and specificity was 99.5% (95% CI 98.7-99.8). Included in the complete list are sensitivity and specificity measures, specimens required, target genes, test details, and manufacturing capabilities (if provided). 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. Karlafti E, Tsavdaris D, Kotzakioulafi E, Kaiafa G, Savopoulos C, Netta S, Michalopoulos A, Paramythiotis D. Life (Basel).