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评估十五种市售血清学检测方法用于莱姆病的诊断。

Evaluation of fifteen commercially available serological tests for diagnosis of Lyme borreliosis.

作者信息

Goossens H A, van den Bogaard A E, Nohlmans M K

机构信息

Department of Medical Microbiology, University of Maastricht, The Netherlands.

出版信息

Eur J Clin Microbiol Infect Dis. 1999 Aug;18(8):551-60. doi: 10.1007/s100960050347.

DOI:10.1007/s100960050347
PMID:10517192
Abstract

The performance of 11 commercially available enzyme immunoassays (EIA) and four Western blot (WB) tests for the detection of IgM and IgG antibodies against Borrelia burgdorferi were compared. A total of 229 serum specimens were used: 26 from patients with early Lyme borreliosis, 13 from patients with late Lyme borreliosis, 62 from healthy controls and 128 from patients with disorders clinically mimicking Lyme borreliosis and/or known to cause cross-reactivity in Lyme borreliosis serological tests (patient control group). In specimens from patients with early Lyme borreliosis, the sensitivity of the individual tests ranged from 35 to 81% for detection of IgM. In late Lyme borreliosis, sensitivity of the tests ranged from 46 to 92%. In healthy controls the specificity of the tests ranged from 89 to 100% and from 82 to 97% for IgM and IgG tests, respectively. In the patient control group, specificity of the tests ranged from 75 to 90% for IgM and from 84 to 100% for IgG tests. The Behring (Germany) and Genzyme Virotech (Germany) IgM EIA tests showed the best performance in detecting early Lyme borreliosis. For the detection of late Lyme borreliosis, the Dako (Denmark) IgG test was the best despite its low sensitivity. The maximum sensitivity of Western blotting for detecting IgM in patients with early Lyme borreliosis and IgG in patients with late Lyme borreliosis was 50 and 46%, respectively. The use of an EIA-WB two-test protocol improved the specificity and positive predictive values of the EIA results but caused a significant loss in sensitivity. Patients with Epstein-Barr virus or cytomegalovirus infection who had a positive reaction in the IgM EIA could not be discriminated from patients with early Lyme borreliosis with the help of Western blotting. Hence, positive and negative predictive values in combination with sensitivity and specificity values indicated that the exclusion of these infections was more relevant than the confirmation of a positive IgM EIA with Western blot.

摘要

比较了11种市售酶免疫测定法(EIA)和4种蛋白质印迹法(WB)检测抗伯氏疏螺旋体IgM和IgG抗体的性能。共使用了229份血清标本:26份来自早期莱姆病患者,13份来自晚期莱姆病患者,62份来自健康对照,128份来自临床症状类似莱姆病和/或已知在莱姆病血清学检测中会引起交叉反应的疾病患者(患者对照组)。在早期莱姆病患者的标本中,各检测方法检测IgM的灵敏度范围为35%至81%。在晚期莱姆病中,检测方法的灵敏度范围为46%至92%。在健康对照中,各检测方法检测IgM和IgG的特异性分别为89%至100%和82%至97%。在患者对照组中,各检测方法检测IgM的特异性为75%至90%,检测IgG的特异性为84%至100%。德国贝林公司和德国基因泰克病毒技术公司的IgM EIA检测方法在检测早期莱姆病方面表现最佳。对于晚期莱姆病的检测,丹麦达科公司的IgG检测方法尽管灵敏度较低,但却是最好的。蛋白质印迹法检测早期莱姆病患者IgM和晚期莱姆病患者IgG的最大灵敏度分别为50%和46%。采用EIA-WB两步检测方案提高了EIA结果的特异性和阳性预测值,但灵敏度显著降低。在IgM EIA中呈阳性反应的爱泼斯坦-巴尔病毒或巨细胞病毒感染患者,无法通过蛋白质印迹法与早期莱姆病患者区分开来。因此,阳性和阴性预测值与灵敏度和特异性值相结合表明,排除这些感染比用蛋白质印迹法确认IgM EIA阳性更为重要。

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