Evaluation of two commercially available rapid diagnostic tests for Lyme borreliosis.

The diagnosis of Lyme disease is very complicated and a single diagnostic method cannot exclude infection. We assessed the performance of two commercially available Borrelia burgdorferi rapid diagnostic tests (RDT) in comparison to multiple laboratory-based diagnostic assays using specimens with a gradually increasing probability of Borrelia infection. Based on 200 specimens, the analytical sensitivities for IgG and IgM were 18 and 23% for the Lyme RDT and 24 and 32% for the Borreliose Complete RDT. The sensitivity for detecting diagnosed Lyme borreliosis cases was low (26% Lyme RDT and 32% with the Borreliose Complete RDT respectively), whereas the specificity was good (85% Lyme RDT and 88% Borreliose Complete). Based on this evaluation, the performance of RDTs in detecting Lyme borreliosis appeared to be below that of laboratory-based diagnostics.