Performance of United States Serologic Assays in the Diagnosis of Lyme Borreliosis Acquired in Europe
Performance of United States Serologic Assays in the Diagnosis of Lyme Borreliosis Acquired in Europe
复制标题
DOI：
10.1093/cid/cit235
复制
发表时间：
2013-08-01
影响因子：
11.8
通讯作者：
Steere, Allen C.
中科院分区：
文献类型：
--
作者：
Branda, John A.;Strle, Franc;Steere, Allen C.
背景美国的医生有时需要对可能在欧洲感染的疑似莱姆病（LB）患者进行评估。使用来自欧洲LB患者的血清样品，我们比较了欧洲和美国血清诊断测试的性能，包括含有Vmp样序列的新一代检测，表达或其C6肽。使用来自在欧洲获得感染的具有早期或晚期疾病表现的LB患者的64个血清样品确定每个测定的灵敏度。用100份来自非流行区健康受试者的血清测定特异性。对于欧洲获得性感染的检测，使用美国检测的传统2层检测（酶联免疫吸附试验[ ELISA]，然后进行免疫印迹）的总体灵敏度和特异性分别为52%和100%，而使用类似的欧洲检测的灵敏度和特异性分别为81%（P = 0.0007）和99%（P = 1.00）。美国C6 ELISA用作独立检测的灵敏度（总体为88%）与使用欧洲检测的传统2层检测的灵敏度在统计学上相当（P = .47），并且特异性为100%。同样，使用标准美国ELISA然后使用C6 ELISA的替代2层算法与使用欧洲检测方法的传统2层检测（P = 0.82）相比，敏感性相当（总体为84%），且特异性保持100%。结论。在传统的2级检测算法中，欧洲检测试剂盒优于类似的美国检测试剂盒。然而，C6 ELISA用作独立测试或在2层算法的第二层中使用欧洲测定法进行常规2层测试，并且可用于任何患者的评估，无论旅行史如何。
Background. Physicians in the United States sometimes need to evaluate a patient for suspected Lyme borreliosis (LB) who may have acquired the infection in Europe. Using serum samples from European LB patients, we compared the performance of European and US serodiagnostic tests, including newer-generation assays containing Vmp-like sequence, expressed or its C6 peptide.Methods. The sensitivity of each assay was determined using 64 serum samples from LB patients with early or late disease manifestations who acquired the infection in Europe. Specificity was measured using 100 sera from healthy subjects from a nonendemic area.Results. For the detection of European-acquired infection, conventional 2-tiered testing (enzyme-linked immunosorbent assay [ ELISA] followed by immunoblotting) using US assays had an overall sensitivity and specificity of 52% and 100%, compared with 81% (P = .0007) and 99% (P = 1.00) using analogous European tests. The sensitivity of a US C6 ELISA used as a stand-alone test (88% overall) was statistically comparable to that of conventional 2-tiered testing using European tests (P = .47) and was 100% specific. Similarly, an alternative 2-tiered algorithm using a standard US ELISA followed by a C6 ELISA was comparably sensitive (84% overall) compared with conventional 2-tiered testing using European assays (P = .82), and specificity remained 100%.Conclusions. European assays outperformed analogous US assays in a conventional 2-tiered testing algorithm. However, a C6 ELISA used as a stand-alone test or in the second tier of a 2-tiered algorithm performed comparably to conventional 2-tiered testing using European assays, and can be used for evaluation of any patient, regardless of travel history.