National Center for AIDS/STD Control and Prevention, Beijing, China.
J Acquir Immune Defic Syndr. 2010 Feb;53 Suppl 1(Suppl 1):S23-6. doi: 10.1097/QAI.0b013e3181c7d494.
To determine the sensitivity and specificity of tests for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV), and syphilis conducted by laboratories of 3 blood collection organizations in a rural area of China.
From October to December 2003, 1068 samples were collected from blood donors presenting to the 3 collection centers. All samples were tested twice using 2 different test kits for HBsAg, HCV, and syphilis. An aliquot was sent to the China National Center for Clinical Laboratories to confirm the local test results. Sensitivities and specificities of the 3 local blood centers/banks were calculated using the results of the National Center for Clinical Laboratories as the gold standard.
The sensitivity of the 3 blood collection center/banks ranged from 0% to 63.2% for HBsAg. For HCV, the sensitivity was 0%, and for syphilis, ranged from 0% to 85.7%. There were no HBsAg positives in one of the blood center/banks, and no syphilis positives in the other. Thus, sensitivity could not be measured for these tests in these 2 facilities. Combining all 3 tests, the overall sensitivity was 55.6%. The specificity was 100%.
The sensitivity of the local laboratories was inadequate and could cause possible infection for an unacceptable number of blood recipients. Action needs to be taken to improve the quality of testing to ensure the safety of the rural blood supply.
确定中国农村地区 3 家采血机构实验室进行乙型肝炎表面抗原(HBsAg)、丙型肝炎病毒(HCV)和梅毒检测的灵敏度和特异性。
2003 年 10 月至 12 月,从 3 个采血中心采集了 1068 份献血者样本。所有样本均使用 2 种不同的 HBsAg、HCV 和梅毒检测试剂盒进行了 2 次检测。将一份样本送到中国国家临床实验室中心以确认当地的检测结果。使用国家临床实验室中心的结果作为金标准,计算了 3 家当地血站/血库的灵敏度和特异性。
3 家采血中心/血库的 HBsAg 灵敏度从 0%到 63.2%不等。对于 HCV,灵敏度为 0%,而梅毒的灵敏度从 0%到 85.7%不等。其中一家血站/血库没有 HBsAg 阳性,另一家没有梅毒阳性。因此,这 2 家机构无法对这些检测进行灵敏度测量。综合所有 3 项检测,总体灵敏度为 55.6%。特异性为 100%。
当地实验室的灵敏度不足,可能导致大量不可接受的血液受血者感染。需要采取行动提高检测质量,以确保农村血液供应的安全性。