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

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 metaanalysis 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 theOmicron variant is circulating, particularly in samples with low viral loads.

Post-Market Surveillance of Six COVID-19 Point-of-Care Tests Using Pre-Omicron and Omicron SARS-CoV-2 Variants

“…All other RADTs evaluated in this study showed no significant change in test performance against Omicron variants. Previous studies evaluating RADTs have consistently reported similar or reduced clinical sensitivity with Omicron as compared to early pandemic variants (21, 37, 39). For example, multiple studies investigating the Abbott Panbio using cultured virus (40) and clinical samples (23, 41) have shown no sensitivity loss against Omicron.…”

“…A meta-analysis by Mohammadie et al (37) on RADT performance revealed a pooled sensitivity of 67% and a non-significant reduction in overall RADT sensitivity against Omicron. While these general trends provide valuable insights into overall RADT performance, the diversity of targets needs to be considered.…”

Analysis of the transmission rate of SARS-CoV-2 Omicron subvariants BA.5.2 and BF.7 based on COVID-19 surveillance data.

“…After the thorough abolishment of the dynamic zero-COVID-19 policy, there was no large-scale nucleic acid testing any more, and COVID-19 rapid antigen test (RAT) kits were primary tools for COVID-19 testing. 10 The secondary means of COVID-19 testing was self-paying nucleic acid testing at hospital. In the absence of the two COVID-19 testing means, it seemed unreasonable to make a diagnosis of COVID-19 via symptoms.…”

Pipette‐free field‐deployable molecular diagnostic kit for bimodal visual detection of infectious RNA viruses

“…[6,7] Reverse transcriptase polymerase chain reaction (RT-PCR) is considered the gold standard method, and several RT-PCR approaches for viral detection have been reported. [8][9][10] However, RT-PCR has a long turnaround time and requires an expensive thermal cycler, which is a bottleneck in resource-limited settings. [11] An alternative technique, loop-mediated isothermal amplification (LAMP) has emerged as a simple, sensitive, and low-cost means for amplification.…”