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Clinical performance of rapid antigen tests in comparison to RT-PCR for SARS-COV-2 diagnosis in Omicron variant: A systematic review and meta-analysis.

作者信息

Mohammadie Zahra Eslami, Akhlaghi Saeed, Samaeinasab Saeed, Shaterzadeh-Bojd Shakiba, Jamialahmadi Tannaz, Sahebkar Amirhossein

机构信息

Student Research Committee, Faculty of Paramedical Sciences, Mashhad University of Medical Sciences, Mashhad, Iran.

Department of Biostatistics, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran.

出版信息

Rev Med Virol. 2023 Mar;33(2):e2428. doi: 10.1002/rmv.2428. Epub 2023 Feb 15.


DOI:10.1002/rmv.2428
PMID:36790832
Abstract

The Omicron variant of concern has a high level of mutations in different genes that has raised awareness about the performance of immunological products such as vaccines and antigen detection kits. In this systematic review and meta-analysis, we investigated whether Omicron had a significant influence on rapid antigen test (RAT) performance in comparison to PCR. We registered this systematic review and meta-analysis in PROSPERO with the registration number CRD42022355510. We searched PubMed, Scopus, Embase, and Web of Science databases systematically to 1 August 2022. After article screening, we assessed the quality of the included studies based on the JBI checklist. Following data extraction, we performed a meta-analysis using R software. We included 18 qualified articles presenting sufficient data about RATs performance in comparison to RT-PCR in Omicron infections. The pooled specificity and sensitivity of RATs were 1.000 (0.997-1.000) and 0.671 (0.595-0.721), respectively. The FDA-approved kits showed a better performance than WHO-approved ones with a sensitivity of 0.728 (0.620-0.815). The use of RATs with nasal swabs showed a higher sensitivity compared with nasopharyngeal swabs. The sensitivity for samples with a CT-value >25 was 0.108 (0.048-0.227). Rapid antigen tests show impaired performance for COVID-19 diagnosis when the Omicron variant is circulating, particularly in samples with low viral loads.

摘要

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引用本文的文献

[1]
Real-world accuracy of SARS-CoV-2 antigen detection compared with qPCR: A cross-sectional study in Toledo - PR, Brazil.

Braz J Infect Dis. 2025

[2]
Population-Level SARS-CoV-2 RT-PCR Cycle Threshold Values and Their Relationships with COVID-19 Transmission and Outcome Metrics: A Time Series Analysis Across Pandemic Years.

Viruses. 2025-1-14

[3]
4D-DIA Proteomics Uncovers New Insights into Host Salivary Response Following SARS-CoV-2 Omicron Infection.

J Proteome Res. 2025-2-7

[4]
Comparing the effectiveness of universal admission testing and risk-based testing at emergency admission for preventing nosocomial COVID-19: a multicenter retrospective cohort study in Japan.

Infect Control Hosp Epidemiol. 2024-10-22

[5]
Development and characterization of monoclonal antibodies recognizing nucleocapsid protein of multiple SARS-CoV-2 variants.

Heliyon. 2024-7-27

[6]
Post-market surveillance of six COVID-19 point-of-care tests using pre-Omicron and Omicron SARS-CoV-2 variants.

Microbiol Spectr. 2024-7-2

[7]
The Suitability of RNA from Positive SARS-CoV-2 Rapid Antigen Tests for Whole Virus Genome Sequencing and Variant Identification to Maintain Genomic Surveillance.

Diagnostics (Basel). 2023-12-7

[8]
Standardization and Comparison of Emergency Use Authorized COVID-19 Assays and Testing Laboratories.

medRxiv. 2023-11-8

[9]
Rapid inactivation and sample preparation for SARS-CoV-2 PCR-based diagnostics using TNA-Cifer Reagent E.

Front Microbiol. 2023-10-6

[10]
Efficacy of novel SARS-CoV-2 rapid antigen tests in the era of omicron outbreak.

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