Comparative evaluation of sars-cov-2 rapid immunochromatographic test assays with chemiluminescent immunoassay for the diagnosis of covid-19

Abstract

BACKGROUND: To date, the molecular assay is the gold-standard method for coronavirus disease 2019 (COVID-19) diagnosis. However, they are expensive and complex. There is a pressing necessity for developing other effective diagnostics for severe acute respiratory syndrome coronavirus (SARS-CoV)-2 patients. Therefore, serological detection of antibodies against SARS-CoV-2 might provide a good alternative. AIM: We aimed to compare and evaluate seven rapid diagnostic tests with Mindray chemiluminescent automated immunoassay as a reference method for SARS-CoV-2 antibodies detection. METHODS: This study included the serum of a total of 49 attendees to the Reference Laboratory of Egyptian university hospitals during the period from April 2021 to May 2021. Anti-COVID-19 antibodies detection in serum samples was performed by Mindray fully automated system as our reference method and seven rapid antibody tests; Wondfo, Vazyme, Dynamiker, Panbio, Artron Maccura and Roche. RESULTS: The chemiluminescent assay revealed 30 (61.2%) positive samples and 19 (38.8%) negative samples for COVID-19 immunoglobulin (Ig) G. For COVID-19 IgM, 11 (22.4%) samples were positive and 38 (77.6%) samples were negative. Anti-SARS-CoV-2 antibodies were not detected in any of the PCR-negative individuals. The best diagnostic performance was demonstrated by Roche IgG and IgM, and Vazyme IgG and IgM antibody tests followed by Panbio. For Roche, the sensitivity and specificity for IgG and IgM were (83.3% and 89.5%) and (72.7% and 81.6%), respectively. Vazyme showed sensitivity and specificity for IgG and IgM were (77.8% and 85.7%) and (75% and 91.7%), respectively. Regards Panbio, the sensitivity and specificity for IgG and IgM were (63.6% and 87.5%) and (50% and 86.7%) respectively. Cohen’s Kappa values revealed a substantial agreement for Roche IgG, Vazyme IgG and IgM of (0.7076, 0.6250, 0.6667) respectively. The worst agreement was reported for Maccura IgG, Wondfo, and Dynamiker IgM with Cohen’s Kappa values of (0.2508, 0.1893, and 0.0313), respectively. CONCLUSIONS: Rapid tests in our study exhibited heterogeneous diagnostic performances. Roche, Vazyme, and Panbio antibody tests showed promising results in concordance with our reference method with the best-reported results. On the other hand, the other tests were inferior and failed in providing valid and reliable results. Further studies are necessary to determine the practicality of these tests in different settings and communities.