Department of Infectious Diseases, Centre Hospitalier Lucie-et-Raymond-Aubrac, Villeneuve-Saint-Georges, France; ESCMID Study Group for Lyme Borreliosis - ESGBOR, Switzerland.
Department of Internal Medicine and Infectious Diseases, Centre Hospitalier Perigueux, Perigueux, France.
Clin Microbiol Infect. 2020 Jan;26(1):51-59. doi: 10.1016/j.cmi.2019.06.033. Epub 2019 Jul 12.
Lyme borreliosis (LB) diagnosis currently relies mainly on serological tests and sometimes PCR or culture. However, other biological assays are being developed to try to improve Borrelia-infection diagnosis and/or monitoring.
To analyse available data on these unconventional LB diagnostic assays through a systematic literature review.
We searched PubMed and Cochrane Library databases according to the PRISMA-DTA method and the Cochrane Handbook for Systematic Reviews of Interventions. We analysed controlled and uncontrolled studies (published 1983-2018) on biological tests for adults to diagnose LB according to the European Study Group for Lyme Borreliosis or the Infectious Diseases Society of America definitions, or identify strongly suspected LB. Two independent readers evaluated study eligibility and extracted data from relevant study reports; a third reader analysed full texts of papers to resolve disagreements. The quality of each included study was assessed with the QUADAS-2 evaluation scale.
Forty studies were included: two meta-analyses, 25 prospective controlled studies, five prospective uncontrolled studies, six retrospective controlled studies and two case reports. These biological tests assessed can be classified as: (i) proven to be effective at diagnosing LB and already in use (CXCL-13 for neuroborreliosis), but not enough to be standardized; (ii) not yet used routinely, requiring further clinical evaluation (CCL-19, OspA and interferon-α); (iii) uncertain LB diagnostic efficacy because of controversial results and/or poor methodological quality of studies evaluating them (lymphocyte transformation test, interferon-γ, ELISPOT); (iv) unacceptably low sensitivity and/or specificity (CD57 natural killer cells and rapid diagnostic tests); and (v) possible only for research purposes (microscopy and xenodiagnoses).
QUADAS-2 quality assessment demonstrated high risk of bias in 25/40 studies and uncertainty regarding applicability for 32/40, showing that in addition to PCR and serology, several other LB diagnostic assays have been developed but their sensitivities and specificities are heterogeneous and/or under-evaluated or unassessed. More studies are warranted to evaluate their performance parameters. The development of active infection biomarkers would greatly advance LB diagnosis and monitoring.
莱姆病（LB）的诊断目前主要依赖于血清学检测，有时也会采用聚合酶链反应（PCR）或培养。然而，人们正在开发其他生物检测方法，以尝试提高对伯氏疏螺旋体感染的诊断和/或监测。
通过系统文献回顾，分析这些非传统 LB 诊断检测方法的现有数据。
我们按照 PRISMA-DTA 方法和 Cochrane 系统评价手册对 PubMed 和 Cochrane 图书馆数据库进行了检索。我们分析了针对成人的、根据欧洲莱姆病研究组或美国传染病学会的定义来诊断 LB 或确定疑似 LB 的生物检测的对照和非对照研究（发表于 1983 年至 2018 年）。两位独立的读者评估了研究的纳入标准，并从相关研究报告中提取数据；第三位读者分析了论文的全文，以解决意见分歧。使用 QUADAS-2 评估量表评估了每项纳入研究的质量。
共纳入 40 项研究：两项荟萃分析、25 项前瞻性对照研究、5 项前瞻性非对照研究、6 项回顾性对照研究和 2 项病例报告。这些生物检测可分为以下几类：（i）已被证明对诊断 LB 有效且已在使用（CXCL-13 用于神经莱姆病），但尚未标准化；（ii）尚未常规使用，需要进一步临床评估（CCL-19、OspA 和干扰素-α）；（iii）由于研究结果存在争议和/或方法学质量较差，对其诊断 LB 的效果存在不确定性（淋巴细胞转化试验、干扰素-γ、ELISPOT）；（iv）敏感性和/或特异性较差（CD57 自然杀伤细胞和快速诊断检测）；（v）可能仅用于研究目的（显微镜检查和异体接种诊断）。
QUADAS-2 质量评估显示，40 项研究中有 25 项存在高偏倚风险，32 项研究的适用性存在不确定性，这表明除了 PCR 和血清学检测外，还开发了其他几种 LB 诊断检测方法，但它们的敏感性和特异性存在差异，或者评价不足或未评价。需要更多的研究来评估它们的性能参数。开发活动性感染的生物标志物将极大地促进 LB 的诊断和监测。
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