Performance of United States serologic assays in the diagnosis of lyme borreliosis acquired in Europe
Branda, John A. ...
Background.ŽPhysicians 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.ŽThe sensitivity of each assay was determined using 64 serumsamples from LB patients with early or late disease manifestations who acquired the infection in Europe. Specificity was measured using 100 sera fromhealthy subjects from a nonendemic area. Results.ŽFor the detection of European-acquired infection, conventional 2-tiered testing (enzyme-linked immunosorbent assay [ELISA] followed by immunoblotting) using US assays had anoverall sensitivity and specificity of 52% and 100%, compared with 81% (P = .0007) and 99% (P = 1.00) using analogous European tests. The sensitivity of aUS 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 usinga 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.ŽEuropean 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 tierof 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.
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