A systematic and meta-analysis review on the diagnostic accuracy of antibodies in the serological diagnosis of COVID-19

Abstract Background Serological testing based on different antibody types are an alternative method being used to diagnose SARS-CoV-2 and has the potential of having higher diagnostic accuracy compared current gold standard rRT-PCR. Therefore, objective this review was evaluate IgG IgM point-of-care (POC) lateral flow immunoassay (LFIA), chemiluminescence enzyme (CLIA), fluorescence enzyme-linked (FIA) ELISA systems that detect antigens. Method A systematic literature search carried out in PubMed, Medline complete MedRxiv. Studies evaluating serological assays for were eligible. Study selection data-extraction performed by two authors independently. QUADAS-2 checklist tool assess quality studies. The bivariate model hierarchical summary receiver operating characteristic curve tests. Subgroup meta-analysis explore heterogeneity. Results pooled sensitivity ( n = 17), 16) IgG-IgM 24) LFIA tests 0.5856, 0.4637 0.6886, respectively rRT-PCR method. 9) 10) CLIA 0.9311 0.8516, 10), 11) 5) 0.8292, 0.8388 0.8531 All displayed high specificities ranging from 0.9693 0.9991. Amongst evaluated tests, expressed highest signifying its accurate detection largest proportion infections identified better terms LFIA. except ELISA. Conclusions We report have best overall test accuracy. Moreover, irrespective method, a combined IgG/IgM seems be choice than measuring either type Given poor performances devices, there is need more research development highly specific POC adequate most individual patient applications attractive large sero-prevalence Systematic registration PROSPERO CRD42020179112