The Åland Group for Borreliosis Research, Mariehamn, Finland.
Bimelix Laboratory, Mariehamn, Finland.
Front Cell Infect Microbiol. 2023 Sep 11;13:1108115. doi: 10.3389/fcimb.2023.1108115. eCollection 2023.
The tick-borne multisystemic infection caused by , Lyme borreliosis, or Lyme disease, occurring in temperate regions of the northern hemisphere, continues to spread geographically with the expanding tick population. Despite the rising perceived risk of infection in the population, the clinical diagnosis of Borrelia infection is not always obvious and the most important laboratory test, antibody detection, has limited accuracy in diagnosing active disease. According to international guidelines, the primary serology test, which has a high sensitivity-low specificity, should, be verified using a high specificity confirmation test to improve the specificity. However, this enhancement in specificity comes at the cost of lower sensitivity. This two-step procedure is often omitted in everyday clinical practice. An optimal primary test would be one where no secondary tests for confirmation would be necessary. In the present study, the performance of a novel assay for quantitating IgG1-subclass antibodies to C6-peptide was compared to a commercial reference assay of total IgG and IgM antibodies to C6-peptide in the setting of a high endemic area for borreliosis. A derivation study on a retrospective clinical material was performed to compare the performance parameters and assess the discriminatory properties of the assays, followed by a prospective validation study. The IgG1-antibody assay achieved comparable summary performance parameters to those of the reference assay. The sensitivity was almost 100% while the specificity was about 50%. In a high-endemic setting, characterized by high background seropositivity of about 50% and disease prevalence of approximately 10%, antibody tests are unable to rule-in active infection. The rule-out assessment of the methods revealed that of 1000 patients, 7 - 54 with negative results based on the reference method could have an active infection. Such uncertainty was not found for the index test and may help improve the risk classification of patients.
由 引起的蜱传全身性感染，即莱姆病或莱姆病，发生在北半球温带地区，随着蜱虫数量的增加，其地理范围继续扩大。尽管人们越来越意识到感染的风险，但博雷利氏菌感染的临床诊断并不总是显而易见，最重要的实验室检测——抗体检测，在诊断活动性疾病方面准确性有限。根据国际指南，具有高敏感性-低特异性的主要血清学检测应使用高特异性确认检测进行验证，以提高特异性。然而，这种特异性的提高是以降低敏感性为代价的。在日常临床实践中，通常会省略这两步程序。最佳的初始检测是一种无需进行二次确认检测的检测。在本研究中，在莱姆病高流行地区，比较了一种新型检测 IgG1 亚类抗体对 C6 肽的性能与商业参考检测 IgG 和 IgM 抗体对 C6 肽的性能。通过回顾性临床材料进行了推导研究，以比较检测性能参数并评估检测的鉴别特性，随后进行前瞻性验证研究。IgG1 抗体检测的汇总性能参数与参考检测相当。敏感性几乎为 100%，特异性约为 50%。在高流行地区，背景血清阳性率约为 50%，疾病患病率约为 10%，抗体检测无法确定活动性感染。对方法的排除评估表明，在 1000 名患者中，根据参考方法有 7-54 名结果为阴性的患者可能患有活动性感染。在索引检测中没有发现这种不确定性，这可能有助于改善患者的风险分类。
