Hunfeld Klaus-Peter, Stanek Gerold, Straube Eberhard, Hagedorn Hans-Jochen, Schörner Christoph, Mühlschlegel Fritz, Brade Volker
Central Laboratory of the German Proficiency Testing Program for Bacteriological Infection Serology, Institute of Medical Microbiology, University Hospital of Frankfurt/Main, Germany.
Wien Klin Wochenschr. 2002 Jul 31;114(13-14):591-600.
External quality control surveys are an important tool in regulating the quality of infection serology in general and of borreliosis serology in particular. We report on the results of a Lyme disease proficiency testing program which is regularly organised twice a year by our institutions in close cooperation with the Institute of Standardisation in the Medical Laboratory (INSTAND).
From 1999 to 2001, between 226 and 337 microbiological laboratories participated in each of the four surveys that have been held so far. In addition, between 23 and 30 laboratories from 13 other European countries also participated in each trial. In each survey two serum samples which had been unambiguously characterised by six reference laboratories to contain or not to contain antibodies against the Lyme disease spirochete were distributed in order to determine the accuracy of the diagnostic methods used in participating laboratories. The laboratories also reported interpretative statements of whether or not the test constellation suggested a possible borrelial infection and if an early or late phase of the specific antibody response was suspected.
Test results were found to be in part highly variable and clearly correlated with the manufacturers and the applied test methodology. It was also clear that IgM tests were more difficult to handle than were IgG tests. ELISA-testing was more reproducible and proved to be more sensitive and specific than IFA and IHA testing. Quantification of test results and reporting of specific immunoblot bands also showed high variability. Moreover, for some assays a high number of false positive and false negative test results were reported by the participants.
In view of our results further standardisation of Lyme disease serology is not just desirable but is urgently needed. Moreover, stronger criteria for the validation of available test kits must be applied.
外部质量控制调查是规范一般感染血清学质量，尤其是莱姆病血清学质量的重要工具。我们报告了一项莱姆病能力验证计划的结果，该计划由我们的机构与医学实验室标准化研究所（INSTAND）密切合作，每年定期组织两次。
1999年至2001年期间，在迄今为止举行的四项调查中，每次有226至337个微生物实验室参与。此外，来自其他13个欧洲国家的23至30个实验室也参与了每次试验。在每次调查中，分发了两份血清样本，六个参考实验室已明确鉴定其含有或不含有抗莱姆病螺旋体的抗体，以确定参与实验室所使用诊断方法的准确性。这些实验室还报告了关于测试组合是否提示可能存在伯氏疏螺旋体感染以及是否怀疑处于特异性抗体反应的早期或晚期阶段的解释性声明。
发现测试结果部分差异很大，并且与制造商和所应用的测试方法明显相关。同样明显的是，IgM测试比IgG测试更难操作。酶联免疫吸附测定（ELISA）测试的重复性更高，并且证明比间接荧光抗体试验（IFA）和间接血凝试验（IHA）测试更敏感和特异。测试结果的量化以及特定免疫印迹条带的报告也显示出很大的变异性。此外，对于某些检测方法，参与者报告了大量的假阳性和假阴性测试结果。
鉴于我们的结果，莱姆病血清学的进一步标准化不仅是可取的，而且是迫切需要的。此外，必须对现有测试试剂盒的验证应用更严格的标准。
