Diagnostic accuracy of serological tests and kinetics of severe acute respiratory syndrome coronavirus 2 antibody: A systematic review and meta‐analysis

Abstract

This study aimed to assess the diagnostic test accuracy (DTA) of severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) serological test methods and the kinetics of antibody positivity. Systematic review and meta-analysis were conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. We included articles evaluating the diagnostic accuracy of serological tests and the kinetics of antibody positivity. MEDLINE through PubMed, Scopus, medRxiv and bioRxiv were sources of articles. Methodological qualities of included articles were appraised using QUADAS-2 while Metandi performs bivariate metaanalysis of DTA using a generalized linear mixed-model approach. Stata 14 and Review Manager 5.3 were used for data analysis. The summary sensitivity/specificity of chemiluminescence immunoassay (CLIA), enzyme-linked immunosorbent assay (ELISA) and lateral flow immunoassay (LFIA) were 92% (95% CI: 86%-95%)/ 99% (CI: 97%-99%), 86% (CI: 82%-89%)/99% (CI: 98%-100%) and 78% (CI: 71%-83%)/98% (95% CI: 96%-99%), respectively. Moreover, CLIA-based assays produced nearly 100% sensitivity within 11-15 days post-symptom onset (DPSO).

Evaluation of the automated LIAISON® SARS-CoV-2 TrimericS IgG assay for the detection of circulating antibodies

“…While molecular tests and rapid antigen tests are targeted for early diagnosis, serology tests play a different and perhaps even larger role by supporting epidemiological studies, furthering the understanding of longitudinal immunity, and in assessing the efficacy of vaccine development [5]. The efficient use of serology tests in understanding immunity, both in response to disease or vaccination, requires evaluation of any given assay's diagnostic performance and discriminative ability [6,7].…”

“…Coronavirus spikes form large heavily glycosylated homo-trimeric complexes, yet due to their instability in vitro, monomeric presentations of the spike protein, including the receptor binding domain (RBD) only, have been most prevalently used in immunoassays. While the diagnostic performance of assays using RBD as an antigen have shown better results compared to spike and nucleoprotein antigens [6], the trimeric form was shown to be associated with greater sensitivity for the detection of SARS-CoV-2 IgG antibody in human samples [9]. Here, the performance of the LIAISON ® SARS-CoV-2 TrimericS IgG assay (Emergency Use Authorization, EUA) was evaluated against two assays that utilize the spike RBD as capture antigen: the Siemens ADVIA Centaur COV2G assay in sample remainders from a routine laboratory workflow in New York experiencing high disease prevalence; the Beckman ACCESS SARS-CoV-2 IgG assay from a New Mexico laboratory confronted with a lower disease prevalence.…”

Seroprevalence of severe acute respiratory syndrome coronavirus 2 in Slovenia: results of two rounds of a nationwide population study on a probability-based sample, challenges and lessons learned

“…Elecsys-N is an assay for qualitative detection of total anti-SARS-CoV-2 antibodies against SARS-CoV-2 nucleoprotein (N). The manufacturer's extensive evaluation showed 99.80% specificity and 99.5% sensitivity, and manufacturer-independent evaluations even with values spanning manufacturer claims [ 3 , 5 , [18] , [19] , [20] , [21] , [22] , [23] , [24] ] (see Supplementary material, item S5 ).…”

“…Detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA in nasopharyngeal swabs is a COVID-19 reference diagnostic standard [ 1 , 2 ]. However, because of a significant number of asymptomatic/mild infections, demanding implementation and scale-up of molecular testing and frequent changes in testing strategies, the SARS-CoV-2 RNA positives identified represent only the tip of the pandemic iceberg [ [2] , [3] , [4] ]. As a result, seroprevalence surveys measuring the population immune response to SARS-CoV-2 remain integral for understanding cumulative population exposure and insight into pandemic dynamics during the COVID-19 pre-vaccination era [ 4 , 5 ].…”

<p>Clinical Value of SARS-CoV2 IgM and IgG Antibodies in Diagnosis of COVID-19 in Suspected Cases</p>

“…16 In short, the evaluation of SARS-CoV2 IgM and IgG antibodies serves epidemiological purposes for COVID-19 that are recognized. 17 Many conventional diagnostic studies have reported the diagnostic significance of antibody testing, [18][19][20] but in the general population antibody test should not be used as a diagnostic index. It has diagnostic significance only for suspected cases.…”