Evaluation of serum IgM and IgG antibodies in COVID-19 patients by enzyme linked immunosorbent assay.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is sweeping the world since the end of 2019. The titer change of antibodies against SARS-CoV-2 needs to be further clarified, the clinical and preventive value of antibodies still needs to be further investigated. An enzyme-linked immunosorbent assay (ELISA) was established by coating with SARS-CoV-2 recombinant spike protein and used to detect serum immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against SARS-CoV-2 in coronavirus disease 2019 patients to evaluate the pattern of changes of antibodies. The specificity of the ELISA for detection SARS-CoV-2 IgM and IgG were 96% (144/150) and 100% (150/150), respectively. The sensitivity of ELISA was 100% (150/150) for IgM, and 99.3% (149/150) for IgG. SARS-CoV-2-SP-IgM and SP-IgG antibodies could be detected on Day 1 of hospitalization in 12.5% patients, and SP-IgM began to decrease after reaching its peak at around 22-28 days, and become negative at Month 3 in 30% patients and negative at Month 7 in 79% of these patients after onset; IgG reached its peak around Day 22-28 and kept at a high level within the longest observation period for 4 months, it dropped very sharply at 7 months. The positive rates of SP-IgM and SP-IgG were higher than those of reverse transcription-polymerase chain reaction on Day 7 and 4. The established indirect ELISA has good specificity and sensitivity. IgM and IgG against SARS-CoV-2 appeared almost simultaneously in the early stage, and the level of IgG antibodies could not maintain a high plateau in the observation period of 7 months. Our data will help develop the diagnosis and vaccine of SARS-CoV-2.