Influence of seasonal and operator variations on diagnostic accuracy of lateral flow devices during the COVID-19 pandemic: a systematic review and meta-analysis

Abstract

BackgroundLateral flow tests (LFT) are point-of-care rapid antigen tests that allow isolation and control of disease outbreaks through convenient, practical testing. However, studies have shown significant variation in their diagnostic accuracy. We conducted a systematic review of the diagnostic accuracy of LFTs for the detection of severe acute respiratory syndromecoronavirus 2 (SARS-CoV-2) to identify potential factors affecting their performance. MethodsA systematic search of online databases was carried out to identify studies assessing the sensitivity and specificity of LFTs compared with polymerase chain reaction (PCR) tests. Data were extracted and used to calculate pooled sensitivity and specificity. Meta-regression analysis was conducted to identify covariates influencing diagnostic accuracy. ResultsIn total, 76 articles with 108,820 test results were identified for analysis. Pooled sensitivity and specificity were 72% (95% confidence interval (CI): 0.68-0.76) and 100% (95% CI: 0.99-1.00), respectively. Staff operation of the LFT showed a statistically significant increase in sensitivity (p=0.04) and specificity (p=0.001) compared with self-operation by the test subjects. The use of LFTs in symptomatic patient subgroups also resulted in higher test sensitivity. ConclusionLFTs display good sensitivity and extremely good specificity for SARS-CoV-2 antigen detection; they become more sensitive in patients with symptoms and when performed by trained professionals.

Customizably designed multibodies neutralize SARS-CoV-2 in a variant-insensitive manner

“…Given the critical relevance of the S-ACE2 specific recognition for SARS-CoV-2 entry into the host cell, several inhibitors for this protein-protein interaction (hereafter called binders) have been developed as candidates for therapeutic intervention or as the base of detection devices ( 10 – 12 ). However, the continuous emergence of SARS-CoV-2 variants of concern (VOCs), characterized by mutations located in crucial positions of S, almost invariably reduced the neutralizing capacity of natural antibodies ( 3 ), nanobodies ( 13 ), and designed proteins ( 14 – 16 ).…”