Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-Analysis

Jimin Kim; Heungsup Sung; Hyukmin Lee; Jae-Seok Kim; Sue Shin; Seri Jeong; Miyoung Choi; Hyeon-Jeong Lee; On Behalf Of The Development Committee And Clinical Evidence Research Team In National Evidence-Based Healthcare Collaborating Agency

doi:10.3390/v14071479

Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-Analysis

Viruses. 2022 Jul 6;14(7):1479. doi: 10.3390/v14071479.

Authors

Jimin Kim¹, Heungsup Sung², Hyukmin Lee³, Jae-Seok Kim⁴, Sue Shin⁵, Seri Jeong⁶, Miyoung Choi¹, Hyeon-Jeong Lee¹, On Behalf Of The Development Committee And Clinical Evidence Research Team In National Evidence-Based Healthcare Collaborating Agency

Affiliations

¹ Division of Healthcare Technology Assessment Research, National Evidence-Based Healthcare Collaborating Agency, 400, Neungdong-ro, Gwangjin-gu, Seoul 04933, Korea.
² Departments of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea.
³ Departments of Laboratory Medicine, Yonsei University College of Medicine, 50-1, Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.
⁴ Department of Laboratory Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, 150, Seongan-ro, Gangdong-gu, Seoul 05355, Korea.
⁵ Departments of Laboratory Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, 20, Boramae-ro 5-gil, Dongjak-gu, Seoul 07061, Korea.
⁶ Departments of Laboratory Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, 1, Singil-ro, Yeongdeungpo-gu, Seoul 07441, Korea.

Abstract

Rapid antigen tests (RATs) for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are widely used in the Coronavirus disease 2019 (COVID-19) pandemic caused by diverse variants. Information on the real-world performance of RATs for variants is urgently needed for decision makers. Systematic searches of the available literature and updates were conducted in PubMed, Ovid-MEDLINE, Ovid-EMBASE, CENTRAL, and KMBASE for articles evaluating the accuracy of instrument-free RATs for variants up until 14 March 2022. A bivariate random effects model was utilized to calculate pooled diagnostic values in comparison with real-time reverse transcription-polymerase chain reaction as the reference test. A total of 7562 samples from six studies were available for the meta-analysis. The overall pooled sensitivity and specificity of RATs for variants were 69.7% (95% confidence interval [CI] = 62.5% to 76.1%) and 100.0% (95% CI = 98.8% to 100.0%), respectively. When an additional 2179 samples from seven studies reporting sensitivities only were assessed, the pooled sensitivity dropped to 50.0% (95% CI = 44.0% to 55.0%). These findings suggest reassessment and monitoring of the diagnostic utility of RATs for variants, especially for the sensitivity aspect, to facilitate appropriate diagnosis and management of COVID-19 patients.

Keywords: COVID-19; SARS-CoV-2; performance; rapid antigen test; variant.

Publication types

Meta-Analysis
Review
Systematic Review
Research Support, Non-U.S. Gov't

MeSH terms

COVID-19* / diagnosis
Humans
Pandemics
Point-of-Care Systems
SARS-CoV-2* / genetics
Sensitivity and Specificity

Supplementary concepts

SARS-CoV-2 variants

Grants and funding

This research was funded by National Research Foundation of Korea (NRF), grant number: NRF-2022R1A2C1003503 and National Evidence-Based Collaborating Agency, grant number: NP21-004 and NA22-009.