RESEARCH FOR ESTABLISHMENT OF REFERENCE PANEL FOR CONTROLLING RAPID DIAGNOSIS TESTS OF SARS-COV-2 ANTIBODIES

Abstract

Currently, in the world including Vietnam, there are many rapid diagnostic tests of SARS-COV-2 antigens and antibodies. These test kits must use reference panel for quality control. According to the Food and Drug Administration (FDA)-USA guidelines, reference panel for confirmation testing on manufacturer‘s published specification manufacturer including 75 negative for anti-SARS-CoV-2 antibodies and 30 samples positive for anti-SARS-CoV-2 antibodies.

In thí study, we collected 70 serum samples from volunteers and 75 retrospective serum samples from patients (before April 2019) for research to establish reference panel used to evaluate the quality of rapid diagnostic tests detects antibodies to SARS-CoV-2.

Our study results showed that 50 samples were positive for anti-SARS-CoV-2 antibodies including 3 levels of strong, moderate and weak positive and 75 samples were negative for anti-SARS-CoV-2 antibodies confirmed by the method immunochromatography and immunofluorescence. Among the 50 positive samples and 75 negative samples for anti-SARS-CoV-2 antibodies, the research team selected and establish reference panel including 30 samples positive for anti-SARS-CoV-2 antibodies (including 3 levels of strong, moderate and weak positive) and 75 negative samples with anti-SARS-CoV-2 antibodies that meet the requirements of reference panel that can be used for quality control of rapid diagnostic tests detects antibodies to SARS-CoV-2.