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HIV 항체 신속검사법의 통합민감도와 통합특이도에 대한 메타분석

Meta-Analysis for the Pooled Sensitivity and Specificity of anti-Human Immunodeficiency Virus Ab Rapid Tests

최성은|오흥범|유수진|손용학
대한진단검사의학회 (Korean Society For Laboratory Medicine)|2009.08|Annals of Laboratory Medicine|제29권 제4호|pp. 345-352

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참고문헌

키워드

Meta-analysisHIVRapid test
주제분류병리학

초록

배경 : Anti-human immunodeficiency virus type (HIV) 항체 검사에 대한 접근성 및 신속성을 높이기 위한 HIV 항체 면 역크로마토그래피법(immunochromatography, ICA) 키트들 이 다수 소개되고 있다. 그러나, 현재까지 HIV 항체 ICA에 대 한 성능평가가 충분하지 못한 실정이다. 따라서 본 연구에서는 문헌검색을 통해 얻은 HIV 항체 ICA의 성능평가 연구들에 대 한 메타분석을 통해 통합민감도와 통합특이도를 분석하고자 하 였다. 방법 :‘Human immunodeficiency virus’,‘ HIV Ab’,‘ rapid test’,‘ immunochromatography’,‘ performance’,‘ sensitivity’ 및‘specificity’를 검색어로 조합하여 PubMed 데이 터베이스에서 관련된 문헌을 검색하였다. 혈청이나 EDTA 전혈 을 검체로 ICA 신속검사법에 대해 연구한 것만을 포함하였다. 문헌의 방법론적 질을 평가하기 위해 2명의 검토자가 독립적으 로 STARD 점검표를 근거로 문헌을 검토하였다. 선택된 문헌들 간 동질성이 만족되는지를 알아보고 통합민감도 및 통합특이도 를 구하였다. 이를 이용하여 국내 유병률에 따른 양성예측도 및 음성예측도를 예상해보았다. 결과 : 연구의 질이 높다고 판단된 12개 문헌 23개의 연구 결 과를 최종적으로 분석하였다. 23개의 연구결과는 동질성을 만 족하지 않아(P<0.1) 무작위효과모형을 사용하여 평가하였다. 계 산된 통합민감도는 99.71% (95% CI: 99.45-99.97%), 통합특 이도는 99.27% (95% CI: 98.83-99.70%)이었다. 이를 토대로 HIV 유병률을 0.03%로 가정할 때, HIV 항체 신속검사법 ICA 검사의 국내 양성예측도는 3.936%, 음성예측도는 각각 99.999% 로 예상되었다. 결론 : HIV 항체에 대한 신속검사법 ICA는 본 메타분석을 통 해 비교적 우수한 성능을 보여주었다. 그러나, 낮은 양성예측도 를 고려할 때, 효소면역법 및 western blot을 통한 확인이 요구 된다. 또한 이 연구는 향후 성능평가가 충분하지 않은 키트들에 대한 평가 및 성능기준을 설정하는데 도움이 될 것이다.

Abstract

Background : Many immunochromatography (ICA) kits for anti-human immunodeficiency virus type (HIV) antibody (Ab) have been introduced to improve the accessibility of HIV Ab tests. However, qualified evaluation reports for HIV rapid tests are not enough to validate their performances. Metaanalysis for the performances of the HIV Ab rapid tests was performed in this study. Methods : PubMed database was searched with combination of search terms, ‘human immunodeficiency virus’, ‘HIV Ab’, ‘rapid test’, ‘immunochromatography’, ‘performance’, ‘sensitivity’, and ‘specificity’. Criteria of inclusion were performance studies for HIV ICA kits with serum or EDTA whole blood. Methodological qualities were evaluated with standards for reporting of diagnostic accuracy studies (STARD) checklists by two investigators. Homogeneity among selected studies was evaluated and then pooled sensitivity and specificity were calculated. Positive and negative predictive values were simulated with presumed HIV prevalence in Korea. Results : Twenty-three studies were selected from 12 high-qualified papers with STARD checklists. The performance of 23 studies were found to be heterogeneous (P<0.1) and random effect model was used. Pooled sensitivity was 99.71% (95% CI: 99.45-99.97%) and pooled specificity was 99.27% (95% CI: 98.83-99.70%). With HIV prevalence of 0.03%, positive and negative predictive values were presumed to be 3.936% and 99.999%, respectively. Conclusions : This meta-analysis for HIV ICA rapid tests showed good performance. In consideration of low positive predictive values of HIV rapid tests, confirmation by enzyme immunoassay or Western blot is still needed. This study would be helpful in evaluating and establishing proper performance guideline for those kits not fully evaluated.

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