Performance of Antigen Detection Tests for SARS-CoV-2: A Systematic Review and Meta-Analysis
Anastasia Tapari,Georgia G. Braliou,Maria Papaefthimiou,Helen Mavriki,Panagiota I. Kontou,Georgios K. Nikolopoulos,Pantelis G. Bagos +6 more
TLDR
LFIA tests, though with moderate sensitivity, appear as the most attractive method for use in POCs and for performing seroprevalence studies, and rapid ATs show higher sensitivity in symptomatic patients compared to asymptomatic patients.Abstract:
Coronavirus disease 2019 (COVID-19) initiated global health care challenges such as the necessity for new diagnostic tests. Diagnosis by real-time PCR remains the gold-standard method, yet economical and technical issues prohibit its use in points of care (POC) or for repetitive tests in populations. A lot of effort has been exerted in developing, using, and validating antigen-based tests (ATs). Since individual studies focus on few methodological aspects of ATs, a comparison of different tests is needed. Herein, we perform a systematic review and meta-analysis of data from articles in PubMed, medRxiv and bioRxiv. The bivariate method for meta-analysis of diagnostic tests pooling sensitivities and specificities was used. Most of the AT types for SARS-CoV-2 were lateral flow immunoassays (LFIA), fluorescence immunoassays (FIA), and chemiluminescence enzyme immunoassays (CLEIA). We identified 235 articles containing data from 220,049 individuals. All ATs using nasopharyngeal samples show better performance than those with throat saliva (72% compared to 40%). Moreover, the rapid methods LFIA and FIA show about 10% lower sensitivity compared to the laboratory-based CLEIA method (72% compared to 82%). In addition, rapid ATs show higher sensitivity in symptomatic patients compared to asymptomatic patients, suggesting that viral load is a crucial parameter for ATs performed in POCs. Finally, all methods perform with very high specificity, reaching around 99%. LFIA tests, though with moderate sensitivity, appear as the most attractive method for use in POCs and for performing seroprevalence studies.read more
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Challenges in the Detection of SARS-CoV-2: Evolution of the Lateral Flow Immunoassay as a Valuable Tool for Viral Diagnosis
Nayeli Shantal Castrejón-Jiménez,Blanca Estela García-Pérez,Nydia Edith Reyes-Rodríguez,Vicente Vega-Sánchez,Víctor M. Martínez-Juárez,Juan Carlos Hernández-González +5 more
TL;DR: This review summarizes the advantages, limitations, and evolution of LFIA during the SARS-CoV-2 pandemic and the challenges of improving these diagnostic devices.
Journal ArticleDOI
Positivization time of a COVID-19 rapid antigen self-test predicts SARS-CoV-2 viral load: a proof of concept
Gian Luca Salvagno,Brandon Michael Henry,Giulio Bongiovanni,Simone De Nitto,Laura Pighi,Giuseppe Lippi +5 more
TL;DR: In this article , a proof-of-concept study was conducted to validate the hypothesis that the time of positivization of SARS-CoV-2 self-performed rapid diagnostic tests (RDTs) may reflect the actual viral load in the specimen.
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Unmasking the ‘Asymptomatic’ COVID-19: A Nose Question
TL;DR: The results suggest that most asymptomatic individuals could be unmasked by mass olfactory rapid threshold screening and then referred to traditional slower diagnostic tests.
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Diagnostic accuracy of Siemens SARS-CoV-2 Antigen (CoV2Ag) chemiluminescent immunoassay for diagnosing acute SARS-CoV-2 infection: a pooled analysis
TL;DR: A critical literature review and pooled analysis of diagnostic accuracy of the fully-automated Siemens CoV2Ag chemiluminescent immunoassay for diagnosis of acute SARS-CoV-2 infections was provided in this paper .
Journal ArticleDOI
Clinical Added Value of SARS-CoV-2 Antigen Detection in Blood Samples
Saoussen Oueslati,Melek Manai Manai Bouokazi,Ikrame Ramdhani,Lélia Escaut,Tài Pham,Souad Ouzani,Nadia Anguel,Sophie Bulifon,Christelle Vauloup-Fellous,Audrey Coilly,Laurence Legros,Magali Guichardon,Nicolas Fortineau,Laurent Dortet,Anne-Marie Roque-Afonso,Thierry Naas +15 more
TL;DR: Sensitive immunoassays designed for SARS-CoV-2 Antigen (Ag)-detection in nasopharyngeal (NP) and serum samples are suitable COVID-19-laboratory diagnostic tests, particularly when blood samples are available, thus reducing the requirement for NP sampling, and subsequent PCR analysis.
References
More filters
Journal ArticleDOI
Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement
TL;DR: Moher et al. as mentioned in this paper introduce PRISMA, an update of the QUOROM guidelines for reporting systematic reviews and meta-analyses, which is used in this paper.
Journal ArticleDOI
Bias in meta-analysis detected by a simple, graphical test
TL;DR: Funnel plots, plots of the trials' effect estimates against sample size, are skewed and asymmetrical in the presence of publication bias and other biases Funnel plot asymmetry, measured by regression analysis, predicts discordance of results when meta-analyses are compared with single large trials.
Journal ArticleDOI
Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement
TL;DR: A structured summary is provided including, as applicable, background, objectives, data sources, study eligibility criteria, participants, interventions, study appraisal and synthesis methods, results, limitations, conclusions and implications of key findings.
Journal ArticleDOI
Operating characteristics of a rank correlation test for publication bias.
TL;DR: In this paper, an adjusted rank correlation test is proposed as a technique for identifying publication bias in a meta-analysis, and its operating characteristics are evaluated via simulations, and the test statistic is a direct statistical analogue of the popular funnel-graph.
Journal ArticleDOI
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.
Fernando P. Polack,Stephen J. Thomas,Nicholas Kitchin,Judith Absalon,Alejandra Gurtman,Stephen Lockhart,John L. Perez,Gonzalo Pérez Marc,Edson D. Moreira,Cristiano Zerbini,Ruth Bailey,Kena A. Swanson,Satrajit Roychoudhury,Kenneth Koury,Ping Li,Warren Kalina,David A. Cooper,Robert W. Frenck,Laura L. Hammitt,Özlem Türeci,Haylene Nell,Axel Schaefer,Serhat Ünal,Dina B. Tresnan,Susan Mather,Philip R. Dormitzer,Ugur Sahin,Kathrin U. Jansen,William C. Gruber +28 more
TL;DR: A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older and safety over a median of 2 months was similar to that of other viral vaccines.