National Serology Reference Laboratory, Division of St Vincent's Institute of Medical Research, Melbourne, Victoria, Australia.
PLoS One. 2019 Apr 29;14(4):e0214402. doi: 10.1371/journal.pone.0214402. eCollection 2019.
Spirochaetes of the Borrelia burgdorferi sensu lato complex, which includes those that cause Lyme disease, have not been identified in Australia. Nevertheless, Australian patients exist, some of whom have not left the country, who have symptoms consistent with so-called "chronic Lyme disease". Blood specimens from these individuals may be tested in Australian laboratories and in specialist laboratories outside Australia and sometimes conflicting results are obtained. Such discrepancies cause the patients to question the results from the Australian laboratories and seek assistance from the Australian Government in clarifying why the discrepancies occur. The aim of this study was to determine the level of agreement in results between commonly used B. burgdorferi serology assays in specimens of known status, and between results reported by different laboratories when they use the same serology assay. Five immunoassays and five immunoblots used in Australia and elsewhere were examined for the detection of IgG antibodies to Borrelia burgdorferi sensu lato. Predominantly, archived specimens previously tested for Lyme disease were used for the study and included 639 contributed by seven clinical laboratories located either in Australia or in areas endemic for Lyme disease. Also included were 308 prospectively collected Australian blood donor specimens. All clinical specimens were tested in all 10 assays whereas blood donor specimens were tested in all immunoassays and a subset was tested on immunoblots. With the exception of one immunoblot, the results between the assays agreed with each other in a known positive specimen population ≥ 77% of the time and in a known negative population, 88% of the time or greater. The test results obtained during the study were different from the participating laboratory's less than 2% of the time when the same assay was used. These findings suggest that discordance in results between laboratories is more likely due to variation in algorithms or in the use of assays with different sensitivities or specificities rather than conflicting results being reported from the same assay in different laboratories. In the known negative population, specificities of the immunoassays ranged between 87.7% and 99.7%. In Australia's low prevalence population, this would translate to a positive predictive value of < 4%.
伯氏疏螺旋体（Borrelia burgdorferi）属，包括引起莱姆病的疏螺旋体，尚未在澳大利亚被发现。尽管如此，澳大利亚存在一些患者，他们中的一些人从未离开过这个国家，但却出现了与所谓的“慢性莱姆病”相符的症状。这些个体的血液标本可能在澳大利亚实验室和澳大利亚以外的专业实验室进行检测，有时会得到相互矛盾的结果。这些差异导致患者对澳大利亚实验室的结果提出质疑，并寻求澳大利亚政府协助澄清出现差异的原因。本研究旨在确定在已知状态的标本中，常用伯氏疏螺旋体血清学检测方法之间的结果一致性，以及当不同实验室使用相同的血清学检测方法时报告的结果之间的一致性。在澳大利亚和其他地方使用的五种免疫测定法和五种免疫印迹法被用于检测伯氏疏螺旋体 sensu lato 的 IgG 抗体。本研究主要使用了先前用于莱姆病检测的存档标本，这些标本来自于澳大利亚或莱姆病流行地区的七个临床实验室。此外，还包括 308 份澳大利亚前瞻性采集的献血者标本。所有临床标本均在 10 种检测方法中进行了检测，而献血者标本则在所有免疫测定法中进行了检测，其中一部分在免疫印迹法中进行了检测。除了一种免疫印迹法外，在已知阳性标本群体中，检测方法之间的结果一致性在≥77%的时间内，在已知阴性群体中，在 88%的时间或更长时间内是一致的。当使用相同的检测方法时，研究期间获得的检测结果与参与实验室的结果不同的情况不到 2%。这些发现表明，实验室之间的结果不一致更可能是由于算法的差异，或使用敏感性或特异性不同的检测方法，而不是由于不同实验室使用相同的检测方法报告相互矛盾的结果。在已知的阴性群体中，免疫测定法的特异性在 87.7%至 99.7%之间。在澳大利亚低流行率的人群中，这将转化为阳性预测值<4%。
