Application of SARS-CoV-2 Antigenic Test in asymptomatic workers: sensitivity and specificity of the test

Main Article Content

Giovanni Visci
Carlotta Zunarelli
Francesco Violante
Paolo Boffetta

Keywords

Antigenic Swab, Healthcare workers, Sensitivity, Specificity

Abstract

Background. Healthcare workers (HCW) are at increased risk of being infected with SARS-CoV-2; while PCR test remains gold standard for diagnosis of COVID19 infection, antigen based rapid detection tests have been recently approved by OMS.


Methods. We pooled data on occupational surveillance of 6397 asymptomatic HCW and other employees who were tested for SARS-CoV-2 infection at the University Hospital in Bologna using rapid antigen test between November 16, 2020 and January 29, 2021.


Findings. A total of 17,993 rapid tests were performed, of which 704 for contact with an infected person and 17,289 for voluntary screening. Among 17,732 tests with valid results, 87 tested positive (0.49%) and 17 weakly positive (0.10%).


The sensitivity of the antigenic test was 88.6% (81.1-96.1), the specificity was 93.4% (89-97.8), the positive predictive value, given a prevalence of infection of 42.1%, was 90.7% (84.8-96.6).

Downloads

Download data is not yet available.
Abstract 180 | PDF Downloads 117

References

[1] Center for Systems Science and Engineering (CSSE) COVID-19 Dashboard at Johns Hopkins University (JHU) Accessed June 12 2020
[2] Corman VM, Landt O, Kaiser M, et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020 ;25(3):2000045. Erratum in: Euro Surveill. 2020;25(14): Erratum in: Euro Surveill. 2020;25(30): Erratum in: Euro Surveill. 2021;26(5).
[3] OMS Laboratory Testing Strategy Recommendations for COVID-19. Interim Guidance 21 March
[4] Bustin SA, Benes V, Garson JA, et al. The MIQE guidelines: minimum information for publication of quantitative real-time PCR experiments. Clin Chem. 2009;55(4):611-22. doi: 10.1373/clinchem.2008.112797. Epub 2009 Feb 26.
[5] Vogels CBF, Brito AF, Wyllie AL, et al. Analytical sensitivity and efficiency comparisons of SARS-CoV-2 RT-qPCR primer-probe sets. Nat Microbiol. 2020;5(10):1299-1305. doi: 10.1038/s41564-020-0761-6. Epub 2020 Jul 10. PMID: 32651556.
[6] Tom MR. Mina MJ. To Interpret the SARS-CoV-2 Test, Consider the Cycle Threshold Value. Clin Infect Dis. 2020 ;71(16):2252-2254.
[7] WHO/2019-nCoV/Antigen_Detection/2020.1
[8] Ji T, Liu Z, Wang G, et al. Detection of COVID-19: A review of the current literature and future perspectives. Biosens Bioelectron. 2020 ;166:112455.
[9] Das D, Kammila S, Suresh MR. Development, characterization, and application of monoclonal antibodies against severe acute respiratory syndrome coronavirus nucleocapsid protein. Clin Vaccine Immunol. 2010;17(12):2033-6.
[10] Kohmer N, Toptan T, Pallas C, et al. The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro. J Clin Med. 2021;10(2):328.
[11] Mutti A. Occupational Medicine in the time of COVID-19. Med Lav. 2020;111(2):83-86. doi: 10.23749/mdl.v111i2.9546.
[12] Boffetta P, Violante F, Durando P, et al. Working Group on SARS-CoV-2 Infection in Italian Healthcare Workers. Determinants of SARS-CoV-2 infection in Italian healthcare workers: a multicenter study. Sci Rep. 2021 ;11(1):5788.
[13] Visci G, Lodi V, Bonfiglioli R, et al. Serologic SARS-CoV-2 Testing in Healthcare Workers with Positive RT-PCR Test or Covid-19 Related Symptoms. Archives of Clinical and Biomedical Research 5 (2021): 427-436.
[14] Società Italiana di Medicina del Lavoro, 2020. Esami di laboratorio per SARS-CoV-2 nella gestione in ambito occupazionale della pandemia COVID 19. Posizione della Società Italiana di Medicina del Lavoro. MedLav. 2020; 111 (2): 151–154. DOI:https://doi.org/10.23749/mdl.v111i2.9667.
[15] Ferrari L, Nigro S, Bordini L, Carugno M, Bollati V. SARS-CoV-2 tests in occupational settings: what you look for is what you get. Med Lav. 2021.;112(3):183-189. Available from: https://mattioli1885journals.com/index.php/lamedicinadellavoro/article/view/11472
[16] Jaafar R, Aherfi S, Wurtz N, et al. Correlation Between 3790 Quantitative Polymerase Chain Reaction-Positives Samples and Positive Cell Cultures, Including 1941 Severe Acute Respiratory Syndrome Coronavirus 2 Isolates. Clin Infect Dis. 2021;72(11):e921.
[17] Jefferson T, Spencer EA, Brassey J, Heneghan C. Viral cultures for COVID-19 infectious potential assessment - a systematic review. Clin Infect Dis. 2020:ciaa1764.
[18] Rhee C, Kanjilal S, Baker M, Klompas M. Duration of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infectivity: When Is It Safe to Discontinue Isolation? Clin Infect Dis. 2021;72(8):1467-1474.
[19]https://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2021&codLeg=78155&parte=1%20&serie=null] last access on 22nd March 2021
[20] https://statistichecoronavirus.it/coronavirus-italia] last access on 22nd March 2021
[21] Miller TE, Garcia Beltran WF, Bard AZ, et al. Clinical sensitivity and interpretation of PCR and serological COVID-19 diagnostics for patients presenting to the hospital. FASEB J. 2020;34(10):13877-13884.
[22] Gremmels H, Winkel BMF, Schuurman R, et al. Real-life validation of the Panbio™ COVID-19 antigen rapid test (Abbott) in community-dwelling subjects with symptoms of potential SARS-CoV-2 infection. EClinicalMedicine. 2021;31:100677.
[23] Masiá M, Fernández-González M, Sánchez M, et al. Nasopharyngeal Panbio COVID-19 Antigen Performed at Point-of-Care Has a High Sensitivity in Symptomatic and Asymptomatic Patients With Higher Risk for Transmission and Older Age. Open Forum Infect Dis. 2021 ;8(3):ofab059.
[24] Gremmels H, Winkel BMF, Schuurman R, et al. Real-life validation of the Panbio™ COVID-19 antigen rapid test (Abbott) in community-dwelling subjects with symptoms of potential SARS-CoV-2 infection. EClinicalMedicine. 2021;31:100677.
[25] https://www.finddx.org/covid-19/novel-variants/ last access on 22nd March 2021