Investigating the diagnostic and prognostic value of anti-SARS-CoV-2 Spike IgG/IgM ELISA tests in patients infected with coronavirus Delta variant.

Abstract

Aim: This study aimed to investigate the diagnostic and prognostic value of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Spike IgG/IgM antibodies in patients infected with coronavirus Delta variant.

Methods: This analytical observational study included 270 unvaccinated patients (aged ≥18 years) diagnosed with coronavirus disease 2019 (COVID-19) Delta variant who referred to Emergency Department of our hospital. The serum levels of anti-SARS-CoV-2 Spike IgG and IgM were measured by indirect ELISA. Main measured outcomes included anti-SARS-CoV-2 Spike IgG and IgM, chest computed tomography (CT) severity score, clinical and laboratory findings which were prospectively evaluated throughout the study period.

Results: The IgM levels in critical patients were significantly higher than non-critical patients (p<0.05). But the mean level of IgG in critical patients was not significantly different from its level in non-critical patients (p>0.05). However, a significant positive correlation was observed between the levels of both antibodies and chest CT severity score (p<0.0001); this implies that their levels may reflect the degree of lung involvement. The IgM level on 15^th-16^th days after symptoms onset was significantly associated with the hazard of death even after adjusting for all other factors (adjusted HR (95%CI):1.28(1.014_1.63), p=0.03), whereas IgG was not (p>0.05). The survival probability among patients with IgM level ≥8.67 RU/ml (34.2%) was significantly lower than those with IgM level <8.67 RU/ml (99.5%, p=0.0001).

Conclusions: Anti-SARS-CoV-2 Spike IgM antibody was significantly associated with the disease severity and risk of death in unvaccinated patients infected with coronavirus Delta variant. However, further large-scale investigations on diverse infected populations are required to precisely determine the diagnostic/prognostic value of these antibodies.