Min Ji Kim,HwaYeon Sun, Byung Wook Yoo
Department of Family Medicine, Soonchunhyang University Hospital Seoul, Seoul, Korea
Background: This study compared the neutralizing antibody
kit using the Enzyme-Linked Immunosorbent
Assay (ELISA) method with the rapid antibody diagnostic kit
using the Lateral Flow Immunoassay (LFIA) meth- od to
evaluate the clinical effectiveness of the COVID-19 Biokit
IgG/IgM regarding evaluation of antibody for- mation after
COVID-19 vaccination.
Methods: The neutralizing antibody test was performed with
antibody detection kit of diagnostic medical de-
vices for the qualitative method using the standard ELISA
method. The rapid antibody diagnostic kit was meas-
ured with the COVID-19 Biokit IgG/IgM using the LFIA
method. Based on the results of the neutralizing antibody
measurement test of the standard test method, the test
results of the rapid antibody diagnostic kit are compared and
analyzed to confirm its the sensitivity and specificity.
Results: When the consistency was determined as positive
and negative for the two test results, 118 cases
were matched and two cases were inconsistent, showing a
98.3% consistency rate. That is, sensitivity 98%, specificity
100% and correctly classified proportion 98%.
Conclusions: Although the positive results of antibody
formation of this kit would mean that individual has im-
munity to COVID-19, the result cannot be used to confirm or
evaluate for re-infection. But the strong agreement between
rapid antibody diagnostic kit results and ELISA results
suggests that the kit used in this study is avail- able as a
screening test for antibody and neutralizing antibody
responses, which could help evaluate the need for
additional vaccinations, collect data quickly and cheaply
and monitor individual immune responses.
Korean J Health Promot 2022;22(2):62-67
Keywords: COVID-19, Antibodies, Sensitivity and specificity |