코로나바이러스감염증-19 신속항원검사의 진단적 성능: 민감도와 그 이상의 고려사항
Diagnostic Performance of COVID-19 Rapid Antigen Tests: Considerations in Sensitivity and Beyond
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배경: 최근 코로나바이러스감염증-19 (coronavirus disease-2019, COVID-19) 진단에 사용이 간단하고 결과를 빠르게 알 수 있는 신속항원검사(rapid antigen test, RAT)가 많이 이용되고 있다. 본 연구에서는 새로 개발된 RAT 제품을 기승인된 제품과 비교 평가하고, 추가적으로 진단 성능을 바탕으로 임상적 유용성을 해석하였다. 방법: 기존 검사실에서 실시간 역전사 중합효소연쇄반응법(real-time reverse transcription PCR, rRT-PCR)으로 확인된 상기도 검체 총 804개(양성 258개, 음성 546개)를 이용하여 RADI COVID-19 Ag Rapid Test (RADI)와 STANDARD Q COVID-19 Ag Test (SDQ)의 진단적 성능을 평가하고 분석하였다. 양/음 우도비(positive/negative likelihood ratio, LR+/-)를 Fagan의 노모그램에 적용하여 검사 결과에 따른 질병확률의 변화를 확인하였다. 검사 전 질병확률은 지역 내 2022년도 rRT-PCR 양성률 5.7%를 유병률로 간주하였다. 결과: RADI와 SDQ의 민감도는 각각 82.2%와 62.8%였으며, 특이도는 각각 98.7%와 99.6%였다. RADI와 SDQ의 LR+는 각각 64.1와 171.4였으며, LR-는 각각 0.2와 0.4였다. 이를 Fagan의 노모그램에 적용시, RADI 양성 결과는 검사 후 질병확률을 79.5%, SDQ 양성 결과는 91.2%로 증가시켰다. 결론: RADI의 민감도가 SDQ보다 더 높았으나, 우도비와 유병률을 바탕으로 양성 결과 시의 질병확률을 구했을 때, 오히려 SDQ가 검사 후 질병확률이 더 높았다. 이처럼 검사의 민감도나 특이도 등의 성능과 더불어 검사 결과에 따른 질병확률이나 다음 단계 검사에 대한 진행 필요성 등과 같은 결과 해석에 대한 정보 제공이 필요하다.
Abstract
Background: The rapid antigen test (RAT) is generally used to diagnose coronavirus disease 2019 (COVID-19) because of its ease of use and quick results. We compared a novel RAT with an approved one and interpreted their clinical usefulness based on their diagnostic performance. Methods: Diagnostic performances of the novel RADI COVID-19 Ag Rapid Test (RADI) and the STANDARD Q COVID-19 Ag Test (SDQ) were assessed using a total of 804 residual nasopharyngeal swab samples and confirmed by real-time reverse transcriptase-PCR (rRT-PCR). The positive/negative likelihood ratio (LR+/-) was applied to Fagan’s nomogram to estimate pre- and post-test probability according to the test results. The prevalence of COVID-19 was counted as 5.7%, based on the rRT-PCR positive rate achieved in the laboratory in 2022. Results: The RADI and SDQ had sensitivities of 82.2% and 62.8%, respectively, and specificities of 98.7% and 99.6%, respectively. The LR+ was 64.1 for RADI and 171.4 for SDQ. The LR- was 0.2 for RADI and 0.4 for SDQ. After applying the LR+ to Fagan’s nomogram, the RADI raised the post-test probability to 79.5%, and the SDQ raised it to 91.2%. Conclusions: The RADI was found to be more sensitive than the SDQ. However, when the likelihood ratio and prevalence were taken into consideration, the SDQ showed a higher post-test probability. In addition to the sensitivity and specificity of the tests, it is necessary to provide information on the interpretation of the results, such as the probability based on the test results or whether further tests are necessary.
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