Performance assessment of seven SARS‐CoV‐2 IgG enzyme‐linked immunosorbent assays

Abstract

The pandemic of COVID‐19 has caused enormous fatalities worldwide. Serological assays are important for detection of asymptomatic or mild cases of COVID‐19, and sero‐prevalence and vaccine efficacy studies. Here, we evaluated and compared the performance of seven commercially available enzyme‐linked immunosorbent assay (ELISA)s for detection of anti‐severe acute respiratory syndrome corona virus 2 (SARS‐CoV‐2) immunoglobulin G (IgG). The ELISAs were evaluated with a characterized panel of 100 serum samples from qRT‐PCR confirmed COVID‐19 patients, collected 14 days post onset disease, 100 SARS‐CoV‐2 negative samples and compared the results with that of neutralization assay. Results were analysed by creating the receiver operating characteristic curve of all the assays in reference to the neutralization assay. All kits, were found to be suitable for detection of IgG against SARS‐CoV‐2 with high accuracy. The DiaPro COVID‐19 IgG ELISA showed the highest sensitivity (98%) among the kits. The assays demonstrated high sensitivity and specificity in detecting the IgG antibodies against SARS‐CoV‐2. However, the presence of IgG antibodies does not always correspond to neutralizing antibodies. Due to their good accuracy indices, these assays can also aid in tracing mild infections, in cohort studies and in pre‐vaccine evaluations.

Non-Invasive Detection of SARS-CoV-2 Antigen in Saliva versus Nasopharyngeal Swabs Using Nanobodies Conjugated Gold Nanoparticles

“…However, there are many limitations to using PCR in diagnosis, including low sensitivity and the complex processes that could not meet the urgency of the early diagnosis of the vast numbers of suspected cases, as well as patients' discomfort during nasopharyngeal swabs [18]. Many commercial kits are available for antibodies detection but with uncertain performance [19]. However, earlier diagnosis by antigen-based detection system in the acute phase of the disease is much better for accurate results.…”

Toward the Development of Simplified Lateral Flow Assays Using Hydrogels as the Universal Control Line

“…Enhancing the Sensitivity of Commercial LFA Strips through Hydrogel Modification. Compared to genetic material-based molecular diagnosis (e.g., quantitative reverse transcription-polymerase chain reaction (qRT-PCR)) 39 or antigen/antibody-based immunoassays (e.g., enzyme-linked immunosorbent assays (ELISA)), 40 which require skilled technicians, specific equipment, sophisticated operation, and strict environmental conditions for reagent transportation and storage, LFA is a more convenient and widely used screening tool for various pathogens under nonlaboratory scenarios owing to its low cost and simple operation. Many strategies using the LFA format have been successfully developed for COVID-19 diagnosis in the pandemic situation; the recently presented test strips even could achieve comparable sensitivity with RT-PCR technology.…”

“…Considering only the materials required for the CL, the cost of an HCL containing 3% agarose, 16% gelatin, or 1.5% κ-carrageenan was 99.68, 99.55, and 99.38% lower, respectively, compared to an IgG (Table S2). Furthermore, the traditional approach of obtaining antibody pairs involves the laborious process of preparing monoclonal antibodies and subsequent labeling, followed by extensive screening of potential capture antibody pairs using sandwich ELISA to identify the best combinations . This method is time-consuming and does not facilitate the rapid development of antigen detection methods .…”

Optimization and evaluation of a live virus SARS-CoV-2 neutralization assay

“…Standard immunological assays on the contrary are easy to perform, easy to upscale, less time consuming and does not require BSL3 facilities. Several correlation studies have been performed assessing the applicability of other immunological assays such as ELISA for the use in functional antibody screening [28][29][30][31]. Some report a good correlation between ELISA and neutralization assays [28,30], while others report poor agreement, leaving other serological assays less fit-for-purpose for use in convalescent plasma therapy and other antibody functionality studies [29].…”