The quality of the Polyvac SARS-COV-2 IgG/M ELISA kits for detection of antibodies against SARS-COV-2 on the clinical samples

Abstract

This study aims to evaluated the diagnostic kits for the qualitative detection of IgG/M antibodies against SARS-CoV-2 by ELISA method (Polyvac SARS-CoV-2 IgG/M ELISA) were produced successfully by POLYVAC. It was evaluated on 633 serum samples including 302 positive samples and 331 negative samples from patients confirmed by RT-PCR.  200 positive samples and 200 negative samples were performed in parallel on Polyvac SARS-CoV-2 IgG/M ELISA and Elecsys Anti-SARS-CoV-2 (Roche Diagnostics). Compared to RT-PCR, the Polyvac SARS-CoV-2 IgG ELISA sensitivity and specificity were 86,42% and 100% respectively; the Polyvac SARS-CoV-2 IgM ELISA sensitivity and specificity were 85,43 % and 95,77%, respectively. At different times of 0 - 7 days, 8 - 14 days, >14 days after the symptom onset, the sensitivity of the kits were 34,15 % (95%CI: 21,56% - 44,45%), 92,05% (95%CI: 84,49% - 96,17%), 97,97% (95%CI: 94,21% - 99,31), respectively with IgG and 70,73% (95%CI: 55,22% - 82,39%), 78,41% (95%CI: 68,72% - 85,72%), 92,57% (95%CI: 87,18% - 95,8%) respectively with IgM. Compared to Elecsys Anti-SARS-CoV-2, the results showed that the negative percent agreement was 81% (95% CI : 76.49 - 86.09 %), the positive percent agreement was 98.04% (95% CI: 94.4-99.33%), the total percent agreement was 88,04% (95% CI: 84,45-90,83%). All results showed that Polyvac SARS-CoV-2 IgG/M ELISA could be used in serological test, epidemiological surveillance to determine history of exposure to SARS-CoV-2 and to aid in diagnosis at period after 7 days of symptom onset.