Bjoerkvoll Bjoern, Viet Le, Ol Ha Sam, Lan Nguyen Thi Ngoc, Sothy Sin, Hoel Hedda, Gutteberg Tore, Husebekk Anne, Larsen Stig, Husum Hans
Tromsoe Mine Victim Resource Center, University Hospital of North Norway.
Southeast Asian J Trop Med Public Health. 2010 Sep;41(5):1127-35.
The aim of this study was to determine the accuracy of rapid tests for HBsAg, anti-HBc and anti-HCV in rural Cambodia and Vietnam to detect hepatitis B and C. In a cross-sectional epidemiological study of two populations of 1,200 potential blood donors in rural Cambodia and Vietnam the prevalence rates of HBsAg, anti-HBc and anti-HCV as established by enzyme immunoassay (EIA) tests were compared to rapid test outcomes. The EIA reference test results were validated by Architect Chemiluminescent Microparticle Immunoassay (CMIA) technique. The actual rapid test demonstrated high specificity for all three test categories as claimed by the manufacturer. The test sensitivity observed was significantly lower than that claimed by the manufacturer: 86.5% for HBsAg, 86.6% for anti-HBc, and 76.4% for anti-HCV. There were large and significant variations in test performance between the two countries, especially for HBsAg detection. The low sensitivity of the actual rapid tests for HBsAg, anti-HBc and anti-HCV make them useless for blood donor screening in rural Southeast Asia. Rapid tests may be useful screening tools in blood transfusion services in low-resource settings, but tests should be carefully validated locally before being used for screening purposes since test performance varies by location.
本研究旨在确定柬埔寨农村和越南用于检测乙肝和丙肝的乙肝表面抗原（HBsAg）、乙肝核心抗体（抗-HBc）和丙肝抗体（抗-HCV）快速检测的准确性。在柬埔寨农村和越南针对1200名潜在献血者的两个群体开展的横断面流行病学研究中，将酶免疫测定（EIA）检测确定的HBsAg、抗-HBc和抗-HCV患病率与快速检测结果进行了比较。EIA参考检测结果通过Architect化学发光微粒子免疫测定（CMIA）技术进行了验证。实际的快速检测显示，对于所有三个检测类别，其特异性均如制造商所宣称的那样高。观察到的检测灵敏度显著低于制造商所宣称的灵敏度：HBsAg为86.5%，抗-HBc为86.6%，抗-HCV为76.4%。两国之间的检测性能存在很大且显著的差异，尤其是在HBsAg检测方面。实际的HBsAg、抗-HBc和抗-HCV快速检测灵敏度较低，这使得它们在东南亚农村地区用于献血者筛查毫无用处。快速检测在资源匮乏地区的输血服务中可能是有用的筛查工具，但在用于筛查目的之前，应在当地仔细验证检测，因为检测性能因地点而异。
