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Then the ratio in the formula above is $$ { ap \over ap + (1-b)q } $$. 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. HHS Vulnerability Disclosure, Help doi: 10.1002/14651858.CD013705. In the sample of 1000, there will be around 50 who are currently infected. The Diagnostic Accuracy of SARS-CoV-2 Nasal Rapid Antigen Self-Test: A Systematic Review and Meta-Analysis. 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. Because they detect molecules that are specific to SARS-CoV-2, the specificity of nucleic acid tests for COVID-19 is very high, meaning that a positive result can generally be trusted. Int J Environ Res Public Health. %%EOF Patriquin G, LeBlanc JJ, Williams C, Hatchette TF, Ross J, Barrett L, Davidson R. Microbiol Spectr. Fisher Scientific is always working to improve our content for you. There are $N - P$ who are not infected, and of these the tests of $b(N-P)$ will return negative. 2020 Aug 26;8(8):CD013705. 1772 0 obj <> endobj Clinical SARS-CoV-2 RT-PCR sensitivity estimates, Fig 3. This website is not intended to be used as a reference for funding or grant proposals. 2021 Feb 9;11(2):e047110. -, Altamirano J, Govindarajan P, Blomkalns AL, Kushner LE, Stevens BA, Pinsky BA, Maldonado Y. vefA3uH!8UEk56.Vie=i$| 9X4^#@gFpW5x2(70A]:ZMSl Rapid tests can help you stay safe in the Delta outbreak. ACS Infect Dis. Cochrane Database Syst Rev 3:Cd013705. 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. endstream endobj startxref AN, anterior nasal; NP, nasopharyngeal. Download the complete list of commercial tests (xlsx). The site is secure. 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. 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. AN, anterior nasal;, Participant flowchart. However, the reliability of the tests depends largely on the test performance and the respective sampling method. Relative to qPCR, the BioFire assay had superior performance compared to rapid test in the context of a controlled influenza challenge study. The authors declare no conflict of interest. The ratio $q = (N-P)/N$ is the proportion of uninfected. Accessibility and AMS Online Content, Annual Survey of the Mathematical and Statistical Sciences, Directory of Institutions in the Mathematical Sciences, Information for Undergraduate and High School Students, Research Experiences for Undergraduates (REUs), Catalyzing Advocacy in Science & Engineering (CASE) Fellowship, A survey of PCR tests in the New England Journal of Medicine, 201 Charles Street Providence, Rhode Island 02904-2213. 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. 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). ]bqi"w8=8YWf8}3aK txg^+v!a{Bhk 5YliFeT?}YV-xBmN(}H)&,# o0 doi:10.1001/jamanetworkopen.2020.12005. If you are a manufacturer or research institution that has an EUA-approved antigen or molecular test that is not yet listed, please submit your information here. But you have to use them correctly. Hybridization Chain Reaction Lateral Flow Assays for Amplified Instrument-Free At-Home SARS-CoV-2 Testing. 2022 Nov 18;19(1):191. doi: 10.1186/s12985-022-01922-y. hbbd```b``l%vD2`& }fH=`X\v`,+fH`ld; + That makes another 48, and a total of 93 positive test results. 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. Among 871 paired specimens from asymptomatic participants, 21 (2.4%) were antigen-positive and 17 (2.0%) were real-time RT-PCR-positive. Fig 3. Where can I go for updates and more information? 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. Bethesda, MD 20894, Web Policies 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 YHUZeo{.ecYU`bG &%o/r4$.%2Kf1s|_K'{d]tptptpTZ%DM&t nB7M&t)s9E2GQ(s9sl`W_~UvV`Ae=(z0`lp6:glp6:g|_'>th1c1. Sensitivity and specificity mathematically describe the accuracy of a test which reports the presence or absence of a condition. Sensitivity is calculated based on how many people have the disease (not the whole population). IMPORTANCE Rapid antigen detection devices for SARS-CoV-2 represent a valuable tool for monitoring the spread of infection. -, Moore NM, Li H, Schejbal D, Lindsley J, Hayden MK. 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 Cost: $23.99 for two tests. Shafie MH, Antony Dass M, Ahmad Shaberi HS, Zafarina Z. Beni Suef Univ J Basic Appl Sci. Available from, Kucharski AJ, Klepac P, Conlan A, Kissler SM, Tang M, Fry H, et al.. f While PCR-tests are usually considered as the gold standard to detect infection with the SARS-CoV-2 coronavirus in terms of sensitivity as well as specificity, antigen tests (Ag-Tests) offer practical advantages in terms of costs, logistics and speed [].Because Ag-Tests may play a major role in large scale testing strategies [2, 3] in populations with low prevalence, besides . Of these, 95% = 180 will test positive. endstream endobj 1773 0 obj <>/Metadata 142 0 R/Outlines 202 0 R/Pages 1768 0 R/StructTreeRoot 258 0 R/Type/Catalog>> endobj 1774 0 obj <>/ExtGState<>/Font<>/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 1775 0 obj <>stream Unauthorized use of these marks is strictly prohibited. The Pilot COVID-19 At-Home Test, distributed by Roche Diagnostics, is previously known as the COVID-19 At-Home Test. The nasopharyngeal tract likely has (1) active virus replication and (2) enough virus to be detected in test kits. Epub 2023 Feb 8. In addition, there will be 990 who are not infected, and 5% or about 49 of these will test as positive, making a total of 58. government site. Somborac Baura A, Doroti M, Groi L, Dimbeg M, Dodig S. Biochem Med (Zagreb). 0Q0QQ(\&X 2021 Jun 15;31(2):020601. doi: 10.11613/BM.2021.020601. There are now several studies assessing their accuracy but as yet no systematic . Rapid antigen detection tests using self-collected anterior nasal swabs proved to be as sensitive as and more tolerable than professionally collected nasopharyngeal swabs for CT values up to 30 determined by RT-PCR. This population-based retrospective study was conducted in March-April 2020 in the Helsinki Capital Region, Finland. n?=0 !=GBGKdD&lchl(Ct)!$qV618rey\5x| Additional Information - Quidel's EUA COVID-19 Products (Scroll down to the list of EUA products and enter Quidel in the search box). See this image and copyright information in PMC. 2020 Nov 13;17(1):177. doi: 10.1186/s12985-020-01452-5. 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 . 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. Essentially, a lower limit of detection indicates a more sensitive test, with fewer viral copies per sample necessary to elicit a positive test result. Overall test sensitivity was 84.9% (95% CI 79.1-89.4) and specificity was 99.5% (95% CI 98.7-99.8). 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. All rights reserved. Of these, the fraction who are infected, which we can interpret as the probability that a given person who tests positive is actually one of the infected is $$ { aP \over aP + (1 - b)(N-P) } $$, We can express this formula in terms of probabilities instead of population sizes. Please use the form below to provide feedback related to the content on this product. These tests require samples from the patient that are likely to contain virus. 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. 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. rY,a K^`#G+s.#GO`?Ogggg[[[[[rbrbrbrb\2K9=(zPAe=(z0`lp6:glp6:gO,&n'[Jy;ybv}J* If sensitivity or specificity is not listed, it was not available from the manufacturer at the time of posting. PLoS One 2020. 10.1016/j.jmoldx.2021.01.005 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. Modeling the impact of surveillance activities combined with physical distancing interventions on COVID-19 epidemics at a local level. m 2)g`[Hi i`2D@f8HL] k Looking at these three examples it seems that the test becomes more accurate as the overall probability of infection increases. and transmitted securely. Rapid SARS-CoV-2 antigen detection assay in comparison with real-time RT-PCR assay for laboratory diagnosis of COVID-19 in Thailand. Simple workflow follows a similar format to CLIA-waived QuickVue assays. Available RIDTS detect and differentiate between type influenza A and B viruses, but do not specifically identify or differentiate subtypes of influenza A viruses. Online ahead of print. The FDA has authorized more than 300. %%EOF %PDF-1.5 % 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. 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. 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. 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. 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. Fig 1. Participant flowchart. The QuickVue At-Home COVID-19 Test is a type of test called an antigen test. QuickVue SARS Antigen Test Page 1 of 15 For use under the Emergency Use Authorization (EUA) only . Healthcare professionals can purchase the QuickVue SARS Antigen Test through select authorized distributors. When available, the number of samples used for sensitivity/specificity definitions are listed in the product description. 2023 Feb 3;23(1):240. doi: 10.1186/s12889-023-15036-9. Fig 2. 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. (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. With others, you take a sample and mail it in for results. 3`EJ|_(>]3tzxyyy4[g `S~[R) doi: 10.1136/bmjopen-2020-047110. Molecular tests called nucleic acid amplification tests (NAAT) rely on amplification of existing genetic material in the sample. hbbd```b``1A$" 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. 2023 All rights reserved. Unauthorized use of these marks is strictly prohibited. Many tests now available or in development can use saliva or nasal swabs that facilitate easier sampling procedures for healthcare providers and patients. Many of these are somewhat technical, but still readable. National Library of Medicine 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. Dan Med J 68:A03210217. For in vitro diagnostic use . The QuickVue SARS Antigen Test is authorized for use on anterior nares (NS) swab specimens directly from . Sample Size and Duration of Study: The aim is to test 100 unique patients. 50]P]&Ljn00a@fb` 9!f 9 Now the probability that the Governor is infected would be 180/220 = 82%, much higher than before. 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. 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. 1812 0 obj <>stream Often called "rapid tests" or "home COVID tests," these rapid antigen tests rely on a. ShelfLife : At least 9 months from date of manufacture. Epub 2022 Feb 16. 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. 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. -, Fh B, Borsche M, Balck A, Taube S, Rupp J, Klein C, Katalinic A. 0 Sensitivity and specificity are measures that are critical for all diagnostic tests. Every antigen test for SARS-CoV-2 authorized for use by FDA is included on FDA's list of In Vitro Diagnostics EUAs. 1772 0 obj <>stream j=S+wE-V`~;j`E'w=YX2xx[tdQR8*Bx"y5HMeM(362-*4CmV3aM$ YE`&zVY9{t~ 0 q0 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. Xie JW, Zheng YW, Wang M, Lin Y, He Y, Lin LR. Federal government websites often end in .gov or .mil. Never miss a story with Governing's Daily newsletter. Comparison of two commercial platforms and a laboratory developed test for detection of SARS-CoV-2 RNA. Detects SARS-CoV-2 antigens directly from anterior nares swab specimens. Clipboard, Search History, and several other advanced features are temporarily unavailable. 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 Dec;7(4):811-822. doi: 10.1016/j.idm.2022.11.001. This site needs JavaScript to work properly. endstream endobj startxref 194 0 obj <> endobj General Information - Coronavirus (COVID-19) What kind of antigen and molecular tests are on the market? 858.552.1100 Tel 858.453.4338 Fax How do molecular tests detect SARS-CoV-2? 2022 Feb 23;10(1):e0245521. Please enable it to take advantage of the complete set of features! A positive test result for COVID-19 indicates that Assessment of sensitivity and specificity of patient-collected lower nasal specimens for severe acute respiratory syndrome coronavirus 2 testing. Online ahead of print. 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. 0 AN, anterior nasal; NP, nasopharyngeal. 266 0 obj <>stream Complications of nasal and pharyngeal swabs: a relevant challenge of the COVID-19 pandemic? In this case, 45 out of the true 50 infected will be caught, and 5 who will not be tagged. Individual test results. CDC: %PDF-1.5 % Finally, Quidel QuickVue touts an 83 . 2023 Jan 19;13(2):281. doi: 10.3390/life13020281. 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. Brain Disord. Travel Med Infect Dis. Please enable it to take advantage of the complete set of features! Cochrane Database Syst Rev. Conclusions: Effectiveness of isolation, testing, contact tracing and physical distancing on reducing transmission of SARS-CoV-2 in different settings. The QuickVue SARS Antigen Test provides accurate and reliable results in 10 minutes. By clicking Submit, you acknowledge that you may be contacted by Fisher Scientific in regards to the feedback you have provided in this form. 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. Background: It is aimed to detect the sensitivity and specificity of rapid antigen detection of group A beta hemolytic streptococci from throat specimen compared with throat culture. Then of our 1000, 10 will be infected. Unable to load your collection due to an error, Unable to load your delegates due to an error. $161.00 / Pack of 25. If a diagnostic test correctly identified 100% of all positive results, it would be as sensitive as possible. -, 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. 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). That makes $aP + (1-b)(N-P)$ in total who 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. 238 0 obj <>/Filter/FlateDecode/ID[<14C460633FC69F4E942E936439209C81>]/Index[194 73]/Info 193 0 R/Length 178/Prev 276921/Root 195 0 R/Size 267/Type/XRef/W[1 3 1]>>stream Diagnostics able to detect current, active infections are typically antigen- and molecular-based tests. -. 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 duration of this study will be determined based upon the number of specimens collected daily. Indirect Virus Transmission via Fomites Can Counteract Lock-Down Effectiveness. The QuickVue At-Home OTC COVID-19 Test is a lateral flow immunoassay, with results readable by eye. This finding illustrates the reliability of tests obtained by adequate self-collected anterior nasal specimen. This work was supported by Academy of Finland (ELKE, grant no 308913) and Doctoral Programme in Biomedicine, Faculty of Medicine, University of Helsinki (SJ). 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. %PDF-1.6 % Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. 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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.