Evaluation of the Modified Two-Tiered Testing Method for Diagnosis of Lyme Disease in Children.
Evaluation of the Modified Two-Tiered Testing Method for Diagnosis of Lyme Disease in Children.
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改良两级检测方法诊断儿童莱姆病的评估。
DOI：
10.1128/jcm.00547-19
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发表时间：
2019
影响因子：
9.4
通讯作者：
Nigrovic,LiseE
中科院分区：
文献类型：
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作者：
Lipsett,SusanC;Branda,JohnA;Nigrovic,LiseE
莱姆病的常规两级检测（CTTT）包括第一级酶免疫测定（EIA），然后是补充免疫印迹，而改良的两级检测（MTTT）依赖于两个不同的连续EIA，而不包括免疫印迹。MTTT作为诊断成人莱姆病的替代策略已显示出有希望的结果，但尚未在儿童中进行评估。我们对接受疑似莱姆病临床研究的≤21岁儿童和青少年进行了一项横断面研究。采用全细胞超声（WCS）和C6 EIA分析血清标本，如果EIA为阳性或不确定，则采用补充免疫印迹法。我们使用McNemar检验比较了CTTT（WCS EIA，然后是补充免疫印迹）和MTTT（WCS EIA，然后是C6 EIA），以评估超出偶然性的一致性。然后，我们使用Kappa统计量来衡量测试策略之间的一致性水平。我们纳入了1，066份血清标本，其中156份（14.6%）CTTT阳性，165份（15.5%）MTTT阳性。MTTT和CTTT之间无显著差异（P= 0.16）。虽然MTTT和CTTT之间的总体一致性很高（kappa，0.88; 95%置信区间，0.84至0.92），33名儿童的测试结果不一致。在一组接受疑似莱姆病调查的儿童和青少年中，CTTT和MTTT结果在大多数情况下一致。由于免疫印迹耗时、费力且难以解释，MTTT为儿童提供了一种有前途的替代莱姆病检测策略。
Conventional two-tiered testing (CTTT) for Lyme disease includes a first-tier enzyme immunoassay (EIA) followed by a supplemental immunoblot, and modified two-tiered testing (MTTT) relies on two different sequential EIAs without the inclusion of an immunoblot. MTTT has shown promising results as an alternative strategy for the diagnosis of Lyme disease in adults but has not yet been evaluated in children. We performed a cross-sectional study of children and adolescents ≤21 years of age undergoing clinical investigation for suspected Lyme disease. Serum specimens were analyzed with both a whole-cell sonicate (WCS) and a C6 EIA, with a supplemental immunoblot if either EIA was positive or equivocal. We compared CTTT (WCS EIA followed by supplemental immunoblot) to MTTT (WCS EIA followed by C6 EIA) using McNemar’s test to evaluate for agreement beyond chance alone. We then used a kappa statistic to measure level of the agreement between testing strategies. We included 1,066 serum specimens, of which 156 (14.6%) had a positive CTTT and 165 (15.5%) had a positive MTTT. There were no significant differences between MTTT and CTTT (P= 0.16). Although the overall agreement between MTTT and CTTT was high (kappa, 0.88; 95% confidence interval, 0.84 to 0.92), 33 children had discordant test results. In a cohort of children and adolescents undergoing investigation for suspected Lyme disease, CTTT and MTTT results agreed in most cases. Since immunoblots are time-consuming, laborious, and challenging to interpret, MTTT provides a promising alternate Lyme disease testing strategy for children.