Covid-19 antigen testing: better than we know? A test accuracy study

. 2021 Sep ; 53 (9) : 661-668. [epub] 20210514

Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic

Typ dokumentu časopisecké články, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/pmid33985403

BACKGROUND: Antigen testing for SARS-CoV-2 is considered to be less sensitive than the standard reference method - real-time PCR (RT-PCR). It has been suggested that many patients with positive RT-PCR 'missed' by antigen testing might be non-infectious. METHODS: In a real-world high-throughput setting for asymptomatic or mildly symptomatic patients, 494 patients were tested using RT-PCR as well as a single lateral flow antigen test (Ecotest, AssureTech, China). Where the results differed, virus viability was evaluated by cell culture. The test parameters were calculated with RT-PCR and RT-PCR adjusted on viability as reference standards. RESULTS: The overall sensitivity of the used antigen test related to the RT-PCR only was 76.2%, specificity was 97.3%. However, 36 out of 39 patients 'missed' by the antigen test contained no viable virus. After adjusting on that, the sensitivity grew to 97.7% and, more importantly for disease control purposes, the negative predictive value reached 99.2%. CONCLUSIONS: We propose that viability testing should be always performed when evaluating a new antigen test. A well-chosen and validated antigen test provides excellent results in identifying patients who are shedding viable virus (although some caveats still remain) in the real-world high-throughput setting of asymptomatic or mildly symptomatic individuals.

Zobrazit více v PubMed

ECDC (European Centre for Disease Control). Options for the use of rapid antigen tests for COVID-19 in the EU/EEA and the UK: ECDC, 2020. [cited 2020 Dec 30]. Available from: https://www.ecdc.europa.eu/en/publications-data/options-use-rapid-antigen-tests-covid-19-eueea-and-uk

European Commission . Commission recommendation of 28.10.2020 on COVID-19 testing strategies, including the use of rapid antigen tests. Brussels (Belgium): European Commission; 2020.

Dinnes J, Deeks JJ, Adriano A, et al. . Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev. 2021;3:CD013705. PubMed PMC

World Health Organization. Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays: interim guidance, 11 September 2020. Geneva (Switzerland): World Health Organization, 2020. 4

Porte L, Legarraga P, Vollrath V, et al. . Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples. Int J Infect Dis. 2020; 99:328–333. PubMed PMC

Van der Moeren N, Zwart VF, Lodder EB, et al. . Performance evaluation of a SARS-CoV-2 rapid antigen test: test performance in the community in Netherlands. medRxiv. 2020;2020;20215202.

Mak GC, Cheng PK, Lau SS, et al. . Evaluation of rapid antigen test for detection of SARS-CoV-2 virus. J Clin Virol. 2020;129:104500. PubMed PMC

Wölfel R, Corman VM, Guggemos W, et al. . Virological assessment of hospitalized patients with COVID-2019. Nature. 2020;581(7809):465–469. PubMed

Bullard J, Dust K, Funk D, et al. . Predicting infectious SARS-CoV-2 from diagnostic samples. Clin Infect Dis. 2020;71(10):2663–2666. PubMed PMC

He X, Lau EHY, Wu P, et al. . Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med. 2020;26(5):672–675. PubMed

van Kampen JJA, van de Vijver DAMC, Fraaij PLA, et al. . Shedding of infectious virus in hospitalized patients with coronavirus disease (COVID-19): duration and key determinants. medRxiv. 2019;2020:20125310. PubMed PMC

Corman VM, Haage VC, Bleicker T, et al. . Comparison of seven commercial SARS-CoV-2 rapid Point-of-Care Antigen tests. medRxiv. 2020;2020;20230292. PubMed PMC

FIND. Comparative evaluation of lateral flow assay tests that directly detect antigens of SARS-CoV-2. Geneva (Switzerland): Foundation for Innovative New Diagnostics (FIND; ), 2020.

Munster VJ, Feldmann F, Williamson BN, et al. . Respiratory disease in rhesus macaques inoculated with SARS-CoV-2. Nature. 2020;585(7824):268–272. PubMed PMC

Sender R, Bar-On YM, Flamholz A, et al. . The total number and mass of SARS-CoV-2 virions in an infected person. medRxiv. 2020;2020;20232009. PubMed PMC

Young S, Taylor SN, Cammarata CL, et al. . Clinical evaluation of BD Veritor SARS-CoV-2 point-of-care test performance compared to PCR-based testing and versus the Sofia 2 SARS antigen point-of-care test. J Clin Microbiol. 2020;59(1):1. PubMed PMC

Krüger LJ, Gaeddert M, Köppel L, et al. . Evaluation of the accuracy, ease of use and limit of detection of novel, rapid, antigen-detecting point-of-care diagnostics for SARS-CoV-2. medRxiv. 2020;2020;20203836.

Mertens P, De VN, Martiny D, et al. . Development and potential usefulness of the COVID-19 Ag respi-strip diagnostic assay in a pandemic context. Front Med. 2020;7:225. PubMed PMC

FIND. FIND evaluation of RapiGEN Inc. BIOCREDIT COVID-19 Ag. Geneva (Switzerland): Foundation for Innovative New Diagnostics. 2020 [cited 2020 Dec 30]. Available from https://www.finddx.org/wp-content/uploads/2020/10/Rapigen_Ag-INTERIM-Public-Report_20201016-v1.pdf

Tirupathi R, Ramparas TR, Wadhwa G, et al. . Viral dynamics in the upper respiratory tract (URT) of SARS-CoV-2. Infez Med. 2020;28(4):486–499. PubMed

Zobrazit více v PubMed

figshare
10.6084/m9.figshare.13490292.v3

Najít záznam

Citační ukazatele

Možnosti archivace