Clinical validation of a second generation anti‐SARS‐CoV‐2 IgG and IgM automated chemiluminescent immunoassay

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection has proven to be extremely contagious and has spread rapidly all over the world. A key aspect in limiting the virus diffusion is to ensure early and accurate diagnosis. Serological assays could be an alternative in increasing testing capabilities, particularly when used as part of an algorithmic approach combined with molecular analysis. The aim of this study was to evaluate the diagnostic accuracy of a second generation chemiluminescent automated immunoassay able to detect anti‐SARS‐CoV‐2 immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies. Data are carried out on healthy subjects and other infectious diseases pre‐pandemic sera, as controls, and on two different coronavirus disease 2019 hospitalized patient groups (early and late infection time). Data obtained have been analyzed in terms of precision, linearity, sensitivity and specificity. Specificities are: 100% for anti‐SARS‐CoV‐2 IgG and 98% for anti‐SARS‐CoV‐2 IgM, in all patient groups. Sensitivities are: 97%, 100%, and 98% for anti‐SARS‐CoV‐2 IgG and 87%, 83%, and 86% for anti‐SARS‐CoV‐2 IgM in the early infection, in the late infection and in the total patient group, respectively. The Mindray anti‐SARS‐CoV‐2 IgG and IgM assays demonstrated higher sensitivity and specificity, indicating that IgG and IgM simultaneous detection is useful even in the early phases of infection.

SARS-CoV2 serology assays: utility and limits of different antigen based tests through the evaluation and the comparison of four commercial tests

“…Third is the ECLIA Elecsys® technology developed by Roche® which is highly efficient regardless of the measured analyte (29,30). For the other tests, such (33,34). This new version of Mindray® was not available at the study writing time and merits to be evaluated.…”

“…Similar low sensitivities for the Vidas® test were reported by Younes et al (88,3 for Vidas®IgG after D21) and by Wolf et al (over all sensitivity of 64,9%CI95%[55,2-73,7] for Vidas®IgM and 73%CI95%[63,7-81] for Vidas®IgG) (31,32). Padoan et al also reported a sensitivity of 86.4 (77.0-93.0) for both Mindray®IgM and IgG tests but a new Mindray® generation would give much better performances: 99% and 96% from D1 to D41 for IgG and IgM, respectively (33,34). This new version of Mindray® was not available at the study writing time and merits to be evaluated.…”

Comparative Evaluation of SARS-CoV-2 Rapid Immunochromatographic Test Assays with Chemiluminescent Immunoassay for the Diagnosis of COVID-19

“…Although the Mindray CLIA assay cannot be considered the serological gold standard test, its analytical performance has been successfully evaluated by Younes et al (2021) and Pieri et al 2021) [24], [25]. Younes et al (2021) reported a total sensitivity and specificity of 90.1% and 95.3% for detecting SARS-CoV-2 IgG and IgM in COVID-19 patients [24].…”

“…Younes et al (2021) reported a total sensitivity and specificity of 90.1% and 95.3% for detecting SARS-CoV-2 IgG and IgM in COVID-19 patients [24]. Pieri et al (2021) found that Mindray anti-SARS-CoV-2 IgG and IgM assays demonstrated high sensitivity and specificity both in the early infection (97% and 100% for IgG, 87% and 98% for IgM, respectively) and in the late infection (100% and 100% for IgG, 83% and 98% for IgM, respectively) [25].…”

Long-Term Persistence and Relevant Therapeutic Impact of High-Titer Viral-Neutralizing Antibody in a Convalescent COVID-19 Plasma Super-Donor: A Case Report

“…Currently, the use of hyperimmune plasma is limited by a number of critical issues, including little knowledge about the persistence of post-COVID-19 immunity in convalescents, lack of a consensus on a potential donor's eligibility criteria, and a lack of standardized methods to quantitate the specific anti-SARS-CoV-2 humoral immunity. Regarding this last pivotal issue, a great number of different methods and technical approaches have been devised to measure the immune response of COVID-19, while the Ab kinetics and their pathological and prognostic relevance remain poorly understood (9)(10)(11)(12). In addition, commercially available enzyme immunoassays could have a low accuracy to detect neutralizing titers (NTs) suitable for hyperimmune plasma donation, although they are endowed with high diagnostic accuracy to detect anti-SARS-CoV-2 Abs (13,14).…”