Evaluation of Performance of Detection of Immunoglobulin G and Immunoglobulin M Antibody Against Spike Protein of SARS-CoV-2 by a Rapid Kit in a Real-Life Hospital Setting

Abstract

BackgroundAntibody testing is often used for serosurveillance of coronavirus disease 2019 (COVID-19). Enzyme-linked immunosorbent assay and chemiluminescence-based antibody tests are quite sensitive and specific for such serological testing. Rapid antibody tests against different antigens are developed and effectively used for this purpose. However, their diagnostic efficiency, especially in real-life hospital setting, needs to be evaluated. Thus, the present study was conducted in a dedicated COVID-19 hospital in New Delhi, India, to evaluate the diagnostic efficacy of a rapid antibody kit against the receptor-binding domain (RBD) of the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).MethodsSixty COVID-19 confirmed cases by reverse transcriptase–polymerase chain reaction (RT-PCR) were recruited and categorized as early, intermediate, and late cases based on the days passed after their first RT-PCR–positive test report, with 20 subjects in each category. Twenty samples from pre-COVID era and 20 RT-PCR–negative collected during the study period were taken as controls. immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against the RBD of the spike (S) protein of SARS-CoV-2 virus were detected by rapid antibody test and compared with the total antibody against the nucleocapsid (N) antigen of SARS-CoV-2 by electrochemiluminescence-based immunoassay (ECLIA).ResultsThe detection of IgM against the RBD of the spike protein by rapid kit was less sensitive and less specific for the diagnosis of SARS-CoV-2 infection. However, diagnostic efficacy of IgG by rapid kit was highly sensitive and specific when compared with the total antibody against N antigen measured by ECLIA.ConclusionIt can be concluded that detection of IgM against the RBD of S protein by rapid kit is less effective, but IgG detection can be used as an effective diagnostic tool for SARS-CoV-2 infection in real-life hospital setting.

A Systematic Review and Meta-Analysis Comparing the Diagnostic Accuracy Tests of COVID-19

“…The genetic makeup of SARS-CoV-2 can be investigated using molecular techniques like NGS, enabling its discovery [174], and MA has been utilized for genotyping and the identification of agents that cause diseases like SARS-CoV-2 [175,176]. Additionally, COVID-19 can be detected using the ECLIA serological-based diagnostic methodology [177,178]. The number of chosen studies for these methodologies, however, hindered their inclusion in the meta-analysis because the meta-analysis requires at least five studies with a p-value of less than 0.05 [142].…”

A systematic review and meta-analysis comparing the diagnostic accuracy tests of COVID-19

“…Molecular techniques such as NGS allow the investigation of the genetic composition of SARS-CoV-2, allowing its detection [182], and MA has been used for genotyping and the determination of agents that cause diseases such as SARS-CoV-2 [183,184]. Furthermore, ECLIA serological-based diagnostic technique is a valid detection method for COVID-19 [185,186]; however, the number of selected studies of these techniques prevented their inclusion in the meta-analysis, which needs at least five studies for analysis with a p-value lower than 0.05 [142]. In a search of individual MeSH terms for "COVID-19", "Sensitivity and specificity", "Next generation sequencing", "Microarray Analysis", and "Immunoassay" showed 195,931, 641,415, 49,966, 95,596, and 2,150 studies, respectively, while linking them only found 16, 3 and 367, correspondingly.…”

The Challenges During the COVID-19 Waves in India – from an Intensivists Experience

“…The presence of SARS-CoV-2 virus in atmospheric air and contact surfaces in a COVID-19 dedicated hospital [4] was reported and the appearance of certain specific biochemical indicators such as the M-band(s), β-γ bridging, and pre albumin band signified that a rise in positive acute phase reactants occurred in COVID-19 [5] patients admitted to our hospital. Additionally, the detection of IgM against the receptor-binding domain (RBD) of S protein by the rapid test kit was found to be less effective, but IgG detection was reported as an effective diagnostic tool for SARS-CoV-2 infection [6]. Furthermore, research conducted by the biochemistry department, MAMC also came up with a conclusion that the exposed population in an endemic area of tuberculosis and typhoid is likely to withstand COVID -19 better with a reduced mortality [7].…”