中国流行的伯氏疏螺旋体亚种的标准化免疫印迹解读标准。

Interpretation criteria for standardized Western blot for the predominant species of Borrelia burgdorferi sensu lato in China.

机构信息

State Key Laboratory for Infectious Diseases Prevention and Control, National Institute of Communicable Disease Control & Prevention, Chinese Center of Disease Control & Prevention, Beijing 102206, China.

出版信息

Biomed Environ Sci. 2010 Oct;23(5):341-9. doi: 10.1016/S0895-3988(10)60074-8.

DOI:10.1016/S0895-3988(10)60074-8

PMID:21112481

Abstract

OBJECTIVE

Western blotting (WB; immunoblotting) is a widely used tool for the serodiagnosis of Lyme borreliosis (LB), but so far, no generally accepted criteria for its performance and interpretation have been established in China. The present study was designed to determine the criteria for standardized Western blot for the predominant species of Borrelia burgdorferi sensu lato in China, in which WB was produced with strain PD₉₁ as the representative strain attributed to predominant genospecies Borrelia garinii of Borrelia burgdorferi sensu lato.

METHODS

Approximately 13 bands between 14 and 100 kD were differentiated for strain PD₉₁ by using Gel-Pro analysis software. In a study with 631 serum samples (taken from 127 patients with Lyme borreliosis and 504 controls), all observed bands were documented. To establish criteria for a positive WB result for strain PD₉₁, receiver operating characteristic (ROC) curves were used.

RESULTS

The following interpretation criteria were recommended: for IgG, at least one band of P83/100, P58, P39, P30, OspC, P17, P66, and OspA; for IgM, at least one band of P83/100, P58, OspA, P30, OspC, P17 or P41. In addition, syphilis, leptospirosis and other related diseases should be excluded when the positive band is P41 in IgM. For IgG criteria, the sensitivity is 73.2%, the specificity is 99.4% and Youden index is 0.726; for IgM criteria, the sensitivity is 50.6%, the specificity is 93.1% and Youden index is 0.437.

CONCLUSION

Standardization of WB assays is necessary for comparison of results from different laboratories. Moreover, the criteria of other genospecies of Borrelia burgdorferi sensu lato should be determined in the future to complete the criteria of WB for the diagnosis of the Lyme disease in China.

摘要

目的

免疫印迹（WB；免疫印迹）是莱姆病（LB）血清学诊断的常用工具，但到目前为止，尚未在中国建立普遍接受的 WB 性能和解释标准。本研究旨在确定中国主要伯氏疏螺旋体亚种的标准化 WB 标准，其中使用 PD₉₁株作为代表性菌株，该菌株属于伯氏疏螺旋体亚种的主要种型伯氏疏螺旋体。

方法

使用 Gel-Pro 分析软件对 PD₉₁株进行分析，区分出 14 至 100 kD 之间的约 13 个条带。在一项包含 631 份血清样本（取自 127 例莱姆病患者和 504 名对照者）的研究中，记录了所有观察到的条带。为了建立 PD₉₁株 WB 结果阳性的标准，使用了受试者工作特征（ROC）曲线。

结果

建议采用以下解释标准：对于 IgG，至少有一条 P83/100、P58、P39、P30、OspC、P17、P66 和 OspA 条带；对于 IgM，至少有一条 P83/100、P58、OspA、P30、OspC、P17 或 P41 条带。此外，当 IgM 中的阳性条带为 P41 时，应排除梅毒、钩端螺旋体病和其他相关疾病。对于 IgG 标准，灵敏度为 73.2%，特异性为 99.4%，Youden 指数为 0.726；对于 IgM 标准，灵敏度为 50.6%，特异性为 93.1%，Youden 指数为 0.437。