Humoral immunological kinetics of severe acute respiratory syndrome coronavirus 2 infection and diagnostic performance of serological assays for coronavirus disease 2019: an analysis of global reports

Abstract

As the coronavirus disease 2019 (COVID-19) pandemic continues to rise and second waves are reported in some countries, serological test kits and strips are being considered to scale up an adequate laboratory response. This study provides an update on the kinetics of humoral immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and performance characteristics of serological protocols (lateral flow assay [LFA], chemiluminescence immunoassay [CLIA] and ELISA) used for evaluations of recent and past SARS-CoV-2 infection. A thorough and comprehensive review of suitable and eligible full-text articles was performed on PubMed, Scopus, Web of Science, Wordometer and medRxiv from 10 January to 16 July 2020. These articles were searched using the Medical Subject Headings terms ‘COVID-19’, ‘Serological assay’, ‘Laboratory Diagnosis’, ‘Performance characteristics’, ‘POCT’, ‘LFA’, ‘CLIA’, ‘ELISA’ and ‘SARS-CoV-2’. Data from original research articles on SARS-CoV-2 antibody detection ≥second day postinfection were included in this study. In total, there were 7938 published articles on humoral immune response and laboratory diagnosis of COVID-19. Of these, 74 were included in this study. The detection, peak and decline period of blood anti-SARS-CoV-2 IgM, IgG and total antibodies for point-of-care testing (POCT), ELISA and CLIA vary widely. The most promising of these assays for POCT detected anti-SARS-CoV-2 at day 3 postinfection and peaked on the 15th day; ELISA products detected anti-SARS-CoV-2 IgM and IgG at days 2 and 6 then peaked on the eighth day; and the most promising CLIA product detected anti-SARS-CoV-2 at day 1 and peaked on the 30th day. The most promising LFA, ELISA and CLIA that had the best performance characteristics were those targeting total SARS-CoV-2 antibodies followed by those targeting anti-SARS-CoV-2 IgG then IgM. Essentially, the CLIA-based SARS-CoV-2 tests had the best performance characteristics, followed by ELISA then POCT. Given the varied performance characteristics of all the serological assays, there is a need to continuously improve their detection thresholds, as well as to monitor and re-evaluate their performances to assure their significance and applicability for COVID-19 clinical and epidemiological purposes.

Cellular and Humoral Responses in Dialysis Patients after Vaccination with the BNT162b2 or mRNA-1273 Vaccines

“…Espi et al [ 21 ] screened 106 HDPs 10–14 days after the second dose of BNT162b2 vaccine and registered 19 non-responders (18%), in contrast to the control group in which 100% seroconversion was detected. In accordance with the above results, Strengert et al [ 23 ] and Stumpf et al [ 34 ] detected diminished antibody levels in patients undergoing HD, which, however, reached higher rates of positive immune responses of up to 95%. Of great interest were the findings of Schrezenmeier et al [ 22 ] who observed a gradual increase in the proportion of cases reactive for SARS-CoV-2-IgG antibodies between 1- and 3-week samples, which finally seemed to decrease at a 10-month follow up.…”

“…The adequate laboratory examination of humoral response levels plays a highly significant role in assessing vaccination efficacy. Serological protocols relying on the quantification of specific anti-viral antibodies are considered as reliable biomarkers [ 34 ]. As immunoglobulins targeting receptor binding domain (RBD) account for up to 90% of the formed anti-SARS-CoV-2-specific antibodies [ 35 ], all analyzed studies aim to measure IgG or IgA titers against the S1 domain.…”

Research progress of severe acute respiratory syndrome coronavirus 2 on aerosol collection and detection

“…Anti-SARS-CoV-2 IgM is not detected in individuals who have not been infected with SARS-CoV-2 and is also absent in the early stage of infection. After exposure to SARS-CoV-2 infection, IgM values increase, peaking in the third week [105] . The detection sensitivity is significantly higher than that of RT-qPCR 1 week after the disease onset.…”

New detection method of SARS-CoV-2 antibodies toward a point-of-care biosensor

“…Likewise, the differences between SARS-CoV and SARS-CoV-2 RBD are sufficiently important that there is no cross binding of specific monoclonal antibodies (Wrapp et al, 2020). Consequently, it is pertinent to define S protein, particularly the RBD, in SARS-CoV-2 as both a therapeutic and diagnostic target (Shi et al, 2020;Tai et al, 2020;Wrapp et al, 2020;Zhao et al, 2020;Emeribe et al, 2022).…”

“…In COVID-19, the cumulative seroconversion rate increases rapidly during the first 2 weeks of the onset of SARS-CoV-2 infection, exceeding 50% (Zhao et al, 2020). The adaptive response begins during the ongoing infection (between 1 week and 2 weeks), with the increase of IgM levels until reaching a maximum (in 3 weeks) and then decreasing in an inverse relationship with the concomitant increase of IgG levels (3 weeks-7 weeks), whose affinity for the antigen and neutralization capacity is greater (Galipeau et al, 2020;Guo et al , 2020;Post et al, 2020;Sette and Crotty, 2021;Emeribe et al, 2022).…”