메타분석을 이용한 B형 간염 항원 신속검사법의 통합민감도와 통합특이도 분석
Meta-Analysis for the Pooled Sensitivity and Specificity of Hepatitis B Surface Antigen Rapid Tests
0
조회
0
다운로드
3
인용
0
참고문헌
초록
Abstract
Background : Although hepatitis B surface antigen (HBsAg) rapid test based on immunochromatographic assay (ICA) is now widely used, the test has not been evaluated sufficiently enough to validate its performance. Thus, it is important to summarize the clinical performance of the test kits. In this study, we performed meta-analysis for the performance of the HBsAg rapid tests. Methods : PubMed database was searched using keywords about the accuracy of diagnostic tests for hepatitis B virus (HBV) infection. Two investigators assessed methodological quality utilizing standards for reporting of diagnostic accuracy studies (STARD) checklist. After performing a heterogeneity test, we obtained pooled sensitivity and specificity. Positive and negative predictive values (PPV and NPV) were simulated according to HBV prevalence. Results : A total of 38 studies was selected from 10 papers. The quality scores ranged from 3 to 13 (median, 8). Kappa value was good (0.85). The performance of the 38 studies was heterogeneous. When 33 studies with better quality from 7 papers were re-selected, the pooled sensitivity and specificity were 98.07% (95% confidence interval, CI: 97.67-98.47%) and 99.56% (95% CI: 99.21-99.91%), respectively. With an HBV prevalence of 5%, PPV and NPV were predicted to be 92.14% and 99.90%, respectively. Conclusions : In view of high HBV prevalence in Korea, it is thought that the HBsAg rapid test can be used for HBV screening in small-sized laboratories or for epidemiologic studies. This study should be helpful in establishing a guideline for the proper performance evaluation of the HBsAg rapid tests. (Korean J Lab Med 2008;28:160-8)
참고문헌 (27)
- Lee WM, "Hepatitis B virus infection", N Engl J Med, 337, pp.1733~1745 (1997)
- Duk-HeeLee, "Epidemiological Findings of Hepatitis B Infection Based on 1998 National Health and Nutrition Survey in Korea", Journal of Korean Medical Science, 17(4), pp.457~462 (2002), 대한의학회
- Cha YJ, "Annual report on external quality assessment in immunoserology in Korea", J Lab Med & Quality Assurance, 25, pp.51~72 (2002)
- 차영주, "면역혈청검사 신빙도조사 결과보고(2006)", 임상검사와정도관리, 29(1), pp.45~64 (2006), 대한임상검사정도관리협회
- Oh J, "Evaluation of Genedia HBsAg Rapid and Genedia anti-HBs Rapid for the screening of HBsAg and Anti-HBs", Korean J Clin Pathol, 19, pp.114~117 (1999)
- 황동희, "B형 간염항원 및 항체 검사를 위한 신속검사법과 정량적 효소면역법의 비교", 대한진단검사의학회지, 25(3), pp.186~191 (2005), 대한진단검사의학회
- 차영주, "국내에서 생산되는 면역크로마토그래피법을 이용한 B형간염표면 항원 및항체 검사 제품의 평가", 대한진단검사의학회지, 26(1), pp.52~57 (2006), 대한진단검사의학회
- Reid MC, "Use of methodological standards in diagnostic test research. Getting better but still not good", JAMA, 274, pp.645~651 (1995)
- Lumbreras-Lacarra B, "Methodology in diagnostic laboratory test research in clinical chemistry and clinical chemistry and laboratory medicine", Clin Chem, 50, pp.530~536 (2004)
- Bossuyt PM, "Irwig LM, et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD Initiative", Ann Intern Med, 138, pp.40~44 (2003)
- 김솔잎, "STARD를 이용한 진단검사법 성능평가 연구의 질 평가와 메타분석을 통한 3세대HCV 효소면역 항체검사의 통합민감도와 특이도 분석", 대한진단검사의학회지, 26(4), pp.307~315 (2006), 대한진단검사의학회
- "Hepatitis B surface antigen assays: operational characteristics (phase I)"[URL]
- "Evaluation results of some commercially available HBsAg assays using ICBS HBV clinical panel and ICBS negative panel"[URL]
- Egger M, "Bias in meta-analysis detected by a simple, graphical test", BMJ, 315, pp.629~634 (1997)
- Macaskill P, "A comparison of methods to detect publication bias in meta-analysis", Stat Med, 20, pp.641~654 (2001)
- Clement F, "of a new rapid test for the combined detection of hepatitis B virus surface antigen and hepatitis B virus e antigen", J Clin Microbiol, 40, pp.4603~4606 (2002)
- Lien TX, "Evaluation of rapid diagnostic tests for the detection of human immunodeficiency virus types 1 and 2, hepatitis B surface antigen, and syphilis in Ho Chi Minh City", Vietnam. Am J Trop Med Hyg, 62, pp.301~309 (2000)
- Akanmu AS, "Evaluation of a rapid test kit for detection of HBsAg", eAg in whole blood: a possible method for pre-donation testing, 2006, pp.35, 5~8
- Lau DT, "A rapid immunochromatographic assay for hepatitis B virus screening", J Viral Hepat, 10, pp.331~334 (2003)
- Sato K, "Evaluation of immunochromatographic assay systems for rapid detection of hepatitis B surface antigen and antibody, Dainascreen HBsAg and Dainascreen Ausab", J Clin Microbiol, 34, pp.1420~1422 (1996)
- Hennig H, "Frequency and load of hepatitis B virus DNA in first-time blood donors with antibodies to hepatitis B core antigen", Blood, 100, pp.2637~2641 (2002)
- 황상현1, "Bio-Rad Elite Microplate 장비를 이용한 HBs 항원, HCV, HIV 항원-항체검사시약 평가", 대한진단검사의학회지, 26(6), pp.436~441 (2006), 대한진단검사의학회
- Weber B, "Diagnostic impact of the genetic variability of the hepatitis B virus surface antigen gene", J Med Virol, 78(S1), pp.S59~S65 (2006)
- Weber B, "Evaluation of two new automated assays for hepatitis B virus surface antigen (HBsAg) detection: IMMULITE HBsAg and IMMULITE 2000 HBsAg", J Clin Microbiol, 41, pp.135~143 (2003)
- Saito T, "Quantitative DNA analysis of low-level hepatitis B viremia in two patients with serologically negative chronic hepatitis B", J Med Virol, 58, pp.325~331 (1999)
- Deville WL, "Conducting systematic reviews of diagnostic studies: didactic guidelines", BMC Med Res Methodol, 2, pp.9~ (2002)
- Normand SL, "Meta-analysis: formulating, evaluating, combining, and reporting", Stat Med, 18, pp.321~359 (1999)