quickvue covid test sensitivity and specificity

hb```@(e# endstream endobj startxref 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. eCollection 2022. 10.1016/S1473-3099(20)30457-6 A highly specific test should rule out all true negative results. Quidel QuickVue At-Home COVID-19 Test. Background: 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. -, Mannonen L, Kallio-Kokko H, Loginov R, Jskelinen A, Jokela P, Antikainen J, et al.. However, the reliability of the tests depends largely on the test performance and the respective sampling method. 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. General Information - Coronavirus (COVID-19) In addition, there will be 800 who are not infected, and 5% or about 40 of these will test as positive, making a total of 220. (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. 2021. Nasopharyngeal swabs mark the gold standard for sample collection in suspected respiratory tract infections but are unsuitable for widespread application, as they must be performed by medically trained personnel. declared that COVID -19 was a pandemic on March 11, 2020, and . Accessibility 1755 0 obj <>/Filter/FlateDecode/ID[<1CD2A739A567014B97F17A74AD84D0B4><415B18644B42ED47B92E0A691BA431A3>]/Index[1735 38]/Info 1734 0 R/Length 103/Prev 631128/Root 1736 0 R/Size 1773/Type/XRef/W[1 3 1]>>stream 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 . 2020. 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 8600 Rockville Pike 9975 Summers Ridge Road, San Diego, CA 92121, USA QuickVue SARS Antigen Test. Nasal swab is a good alternative sample for detecting SARS-CoV-2 with rapid antigen test: A meta-analysis. H\j >w%PrNReby6l*s)do@q;@. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. With others, you take a sample and mail it in for results. 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. These measures are not independently validated by the Johns Hopkins Center for Health Security. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Then of our 1000, 200 will be infected. 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. All contact information provided shall also be maintained in accordance with our Xie JW, Zheng YW, Wang M, Lin Y, He Y, Lin LR. Therefore, with these values of sensitivity and specificity, a nominal 48 will be found to be infected, and $850 + 2$ uninfected. For information on serology (antibody) tests, visit our serology tracker or visit our report outlining the needs of a national serology strategy. The viral genomic material for SARS-CoV-2 is ribonucleic acid (RNA), which remains in the body only while the virus is still replicating, even at very low levels. Test parameters were calculated based on the evaluation of 87 participants. %%EOF 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. Similarly, $(1-a)P$ will be infected but test negative. We rapid-tested a sample onsite and compared results with those from reverse transcription PCR and virus culture. 2020 Nov 13;17(1):177. doi: 10.1186/s12985-020-01452-5. Sensitivity refers to the test's. Public health officials are urging Americans to get tested before traveling or gathering with friends and family members, making rapid tests an important tool for curbing a variant that is. Medical articles on testing. 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. 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. No refrigerator space needed. Introduction. Healthcare professionals can purchase the QuickVue SARS Antigen Test through select authorized distributors. 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%. 2023;12(1):6. doi: 10.1186/s43088-023-00342-3. Fig 1. 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. 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. 2020 Aug 26;8(8):CD013705. In children with symptoms, diagnostic sensitivity and specificity were 71.8% and 98.7%, respectively, and in those without symptoms, sensitivity and specificity were 56.2% and 98.6%, respectively. Sensitivity was dependent upon the CT value for each sampling method. 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. 10.1371/journal.pone.0242958 1735 0 obj <> endobj ShelfLife : At least 9 months from date of manufacture. 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. Comparison of the performance of two real-time fluorescent quantitative PCR kits for the detection of SARS-CoV-2 nucleic acid: a study based on large real clinical samples. AN, anterior nasal; NP, nasopharyngeal. Copyright 2008-2023 Quidel Corporation. The following test parameters for the Accula will be calculated using the ID NOW as a comparator: sensitivity, specificity, positive-predictive value, negative predictive value. hbbd```b``kz Kn8/#eoh6=*c^tXpy! 2021 Feb 9;11(2):e047110. 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. 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. 23-044-167. Antigen tests are designed to detect proteins from the virus that causes COVID-19, in anterior nasal swabs. 2022 Dec;7(4):811-822. doi: 10.1016/j.idm.2022.11.001. 2023 Feb 9;52:102548. doi: 10.1016/j.tmaid.2023.102548. We present sensitivity and specificity with 95% confidence intervals (CIs) for each test, and pooled data using the bivariate model. Noninclusion in this list should not be interpreted as a judgment on the validity or legitimacy of tests. FOIA The. The QuickVue SARS Antigen Test provides accurate and reliable results in 10 minutes. Conclusions: %PDF-1.6 % official website and that any information you provide is encrypted 10.1016/j.jmoldx.2021.01.005 dba MicroGen DX, Orig3n 2019 Novel Coronavirus (COVID-19) Test, UNC Health SARS-CoV-2 real-time RT-PCR test, University of North Carolina Medical Center, Infectious Disease Diagnostics Laboratory within the Department of Pathology and Laboratory Medicine at the Childrens Hospital of Philadelphia, Yale New Haven Hospital, Clinical Virology Laboratory, 96.1% (SARS-CoV-2), 95.5% (flu A), 91.7% (flu B), 100% (SARS-CoV-2), 99% (flu A), 96.8% (flu B), NAAT (reverse transcriptase isothermal amplification), Real time TMA, Dual Kinetic Assay (DKA), multiplex, 96.1% (SARS-CoV-2), 100% (flu A), 100% (flu B), 99.6% (SARS-CoV-2), 99.2% (flu A), 100% (flu B), molecular isothermal Reverse Transcriptase Helicase-Dependent Amplification (RT-HDA), isothermal amplification, Home collection, 96.2% (SARS-CoV-2), 100% (flu A), 98.3% (flu B), 100% (SARS-CoV-2), 98.9% (flu A), 100% (flu B), transcription-mediated nucleic acid amplification (TMA), Antigen Paramagnetic Microbead-based Immunoassay, non-isothermal nucleic acid amplification (qSTAR), Isothermal amplification (OMEGA), patented, 98.4% (symptomatic), 99.1% (asymptomatic), GetMyDNA COVID-19 Test Home Collection Kit, 95.2% (symptomatic), 95.4% (asymptomatic), 97.7% (symptomatic), 97.5% (asymptomatic), 96.4% (SARS-CoV-2), 100% (influenza A), 100% (influenza B), 98% (SARS-CoV-2), 99.6% (influenza A), 99.7% (influenza B), 100% (automated extraction), 96.7% (manual), 93.3% (automated extraction), 93% (manual), transcription mediated amplification (TMA), Cedars-Sinai Medical Center, Department of Pathology and Laboratory Medicine, Pathology/Laboratory Medicine Lab of Baptist Hospital, Miami, Florida. Understanding the false negative rates of SARS-CoV-2 RT-PCR testing is pivotal for the management of the COVID-19 pandemic and it has implications for patient management. Specificity is calculated based on how many people do not have the disease. There are $N - P$ who are not infected, and of these the tests of $b(N-P)$ will return negative. We will not share your information for any other purposes. A systematic review of the accuracy of covid-19 tests reported false negative rates of between 2% and 29% (equating to sensitivity of 71-98%), based on negative RT-PCR tests which were positive on repeat testing. 2021;23(4):407416. Sensitivity and specificity mathematically describe the accuracy of a test which reports the presence or absence of a condition. Comparative evaluation of six nucleic acid amplification kits for SARS-CoV-2 RNA detection. Lancet 2020. Quidel Corporation Headquarters: Cochrane Database Syst Rev. That also means that the remainder of the $N-P$ uninfected people, or $(1-b)(N-P)$, will test positive (these are the false positives). Specificity is the ability of the test to identify those the true negatives. All rights reserved. j=S+wE-V`~;j`E'w=YX2xx[tdQR8*Bx"y5HMeM(362-*4CmV3aM$ YE`&zVY9{t~ 0 q0 They have been advocated for use by the World Health Organisation to help control outbreaks and break the chain of transmission of COVID-19 infections. The nasopharyngeal tract likely has (1) active virus replication and (2) enough virus to be detected in test kits. But you have to use them correctly. Meanwhile, clinical studies for Ellume COVID-19 home test showed 96% accuracy for those who had symptoms and 91% accuracy for people who did not have symptoms. 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. doi: 10.1136/bmjopen-2020-047110. 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). If sensitivity or specificity is not listed, it was not available from the manufacturer at the time of posting. FOIA 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.