COVID-19 백신 접종자를 대상으로 한 COVID-19 Biokit IgG/IgM의 임상적 유효성 평가
Evaluation of COVID-19 Biokit IgG/IgM Clinical Effectiveness in COVID-19 Vaccinated Individuals
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연구배경: 본 연구는 ELISA 법을 이용한 중화항체키트와LFIA 법을 이용한 신속항체 진단키트를 비교하여 COVID-19 백신 접종 후 항체 형성 유무 평가 성능에 대한 임상적 유효성을검증하고자 하였다. 방법: 중화항체시험은 표준 ELISA 법을 이용하여 정성적방법에 대한 진단용 의료기기의 항체 검출키트를 이용하여수행하였다. 신속항체 진단키트는 LFIA 방법을 사용하여COVID-19 바이오키트 IgG/IgM으로 측정되었다. 표준시험 방법의 중화항체측정시험 결과를 바탕으로 신속항체 진단키트의 시험 결과를 비교 분석하여 민감도와 특이도를 확인하였다. 결과: 두 검사 방법의 결과를 양성, 음성으로 나누었을 때118건이 일치하고 2건이 불일치해 98.3%의 일치도를 보였다. 즉, 민감도 98% (95% CI, 0.94-1.00), 특이도 100% (95% CI, 0.63-1.00), 양성 예측 100% (95% CI, 0.97-1.00), 음성 예측 80% (95% CI, 0.44-0.97) 및 분별 정확도는 98% (95% CI, 0.94-1.00)였다. 결론: 키트 결과의 항체 양성 반응이 COVID-19에 대한면역성을 의미하거나, COVID-19 재감염에 대한 확인과 평가를 할 수 없지만, 이미 여러 연구를 통해 항체 형성과 면역원성사이의 상관관계가 검증되었기 때문에 항체 검사로 실제로 과거 감염 여부나 백신 접종의 유무를 확인할 수 있다. 신속한 항체 진단키트 결과와 ELISA 결과의 높은 상관성은본 연구에서 사용된 키트가 항체 및 중화항체 반응의 선별검 사로서 이용이 가능함을 시사하며, 이는 추가 예방접종의필요성을 평가하는데 신속하고 저렴하게 개인의 면역 반응을 데이터화하고 모니터링하는 데 도움이 될 수 있다
Abstract
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) method to evaluate the clinical effectiveness of the COVID-19 Biokit IgG/IgM regarding evaluation of antibody formation after COVID-19 vaccination. Methods: The neutralizing antibody test was performed with antibody detection kit of diagnostic medical devices for the qualitative method using the standard ELISA method. The rapid antibody diagnostic kit was measured 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 immunity 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 available 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.
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