IMUGEN, Norwood, Massachusetts, New York Medical College, Valhalla.
Division of Infectious Diseases, New York Medical College, Valhalla.
Clin Infect Dis. 2018 Apr 17;66(9):1407-1410. doi: 10.1093/cid/cix1023.
There are no US Food and Drug Administration (FDA)-approved diagnostic tests for Borrelia miyamotoi infection, an emerging tick-borne illness in the United States. The purpose of this study was to evaluate whether the FDA-approved C6 peptide enzyme-linked immunosorbent assay (ELISA) currently used to diagnose Lyme disease may potentially serve as a diagnostic test for B. miyamotoi infections.
Serum specimens from 30 patients from the northeastern United States with B. miyamotoi infection established by a polymerase chain reaction assay of a blood specimen were tested using the C6 ELISA. To reduce confounding with Borrelia burgdorferi coinfection, 6 sera were excluded: 3 from patients with a positive Western immunoblot for antibodies to B. burgdorferi and 3 from patients for whom immunoblot testing had not been performed.
Twenty-two of 24 (91.7% [95% confidence interval, 73.0%-98.8%]) evaluable B. miyamotoi patients were C6 ELISA reactive, principally on a convalescent-phase serum specimen. C6 ELISA index values were often well above the positive cutoff value of 1.1, exceeding 4 in 11 of the 22 (50.0%) C6 ELISA-reactive patients.
Although previously regarded as a highly specific test for Lyme disease, the C6 ELISA is also regularly reactive on convalescent-phase serum samples of patients from the northeastern United States with B. miyamotoi infection.
目前尚无经美国食品和药物管理局 (FDA) 批准的用于诊断伯氏疏螺旋体感染的检测方法,而伯氏疏螺旋体感染是美国一种新兴的蜱传疾病。本研究旨在评估目前用于诊断莱姆病的 FDA 批准的 C6 肽酶联免疫吸附试验 (ELISA) 是否可能作为伯氏疏螺旋体感染的诊断检测方法。
采用聚合酶链反应检测 30 例来自美国东北部的伯氏疏螺旋体感染患者的血液标本,并用 C6 ELISA 进行检测。为了减少与伯氏疏螺旋体合并感染的混杂,排除了 6 份血清:3 份来自对伯氏疏螺旋体抗体的 Western 免疫印迹呈阳性的患者,3 份来自未进行免疫印迹检测的患者。
24 例可评估的伯氏疏螺旋体患者中有 22 例(91.7% [95%置信区间,73.0%-98.8%])的 C6 ELISA 呈反应性,主要是在恢复期血清标本上。C6 ELISA 指数值通常远高于 1.1 的阳性截断值,在 22 例 C6 ELISA 反应性患者中有 11 例(50.0%)超过 4。
尽管 C6 ELISA 之前被认为是莱姆病的高度特异性检测方法,但对于来自美国东北部的伯氏疏螺旋体感染患者的恢复期血清样本,该检测方法也经常呈反应性。