全国血站丙型肝炎病毒抗体检验室间质量评价

目的：通过丙肝病毒抗体检验室间质量评价工作，掌握 全国血站丙肝病毒抗体血液筛查状况，使献血员血液筛查逐步规范化，提高血站实验室检验的水平和质量。方法：依据国际标准化组织颁布的ISO指南“实验室能力验证试验的建立和实施”，参考美国AABB/CAP血液检验室间质量评价方案，建立我国丙肝抗体检验室间质量评价方案。通过定期向全国参评实验室寄发质控样品，然后对其回报的数据进行统计分析，作出实验室检验水平评价、试剂临床使用评价。结果；参加室间质量评价的单位为：2000年有235家血站参数，2001年有270家血站参加，2002年有310家血站参数。2000-2002年共计发放9批45支质控样品，其中32支阳性样本，13支阴性样本。2000-2002年阳性样本检出率的平均值为98.8%,阴性样本检出率的平均值为99.6%.2000-2002年获满分的实验室所占百分比为：2000年94.9%,2001年79.8%，2002年97.3%，对9批质控样品检测使用国产试剂（主要厂家）的符合率最低为：2000年97.1%，2001年90.5%,2000年97.1%；使用进口试剂（主要厂家）的符合率最低为；2000年100%，2001年86.0%,2002年95.0%。对强阳性或弱阳性样本检测 ，国产试剂（主要厂家）的平均吸光度值A/临界值co高于进口试剂；但对阳性及阴性样本检测，国产试剂（主要厂家）的CV值要大大低于进口试剂。结论：通过室间质评，血站实验室检验水平有明显提高，试剂使用逐步规范化。在检验试剂方面，几家主要国产厂家的试剂灵敏度要高于同类进口试剂，但国产试剂在特异性方面，试剂批内及批间精密度方面较进口试剂仍有差距。

The External Quality Assessment of anti-HCV Testing in Blood Banks in China

Objeetive:Through the external quality assessment for anti-HCV testing.investigate the national level of examination with anti-HCV,standardize the examination method and improve the testing quality in blood banks. Methods: The external quality assessment scheme for anti-HCV testing was established according to the AABB/CAP Proficiency Testing scheme -transmitted viruses.The control samples of anti-HCV were distributed to all laboratories participating the EQA scheme.The rate of laboratories were analyzed statistically.The testing level of laboratories and kit were evaluated. Results: Paticipating laboratories were 235 in 2000, 270 in 2001, 310 in 2002. 45 control samples were distributed to all laboratories in 2000~2002.The average value of the rate of correct result testing with the positive sample were 98.8%, and that with the negative sample were 99.6% in 2000~2002.The rate of laboratories obtaining 100 score (FT score) were 94.9% in 2000, 79.8% in 2001,97.3% in 2002.With strong or weak positave samples testing,the average values of A/cut off values of major domestic kits were higher than that of foreign kits.With negative samples testing,the CV values of major domestic kits were lower than that of foreign kits. Conclusions:The EQA scheme is useful to finding the problems and the improvement of detection ability of laboratories-The sensitivity of some domestic kits was better than that of foreign kits,but the foreign kits was better than domestic kits in the precision of kit.