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

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Abstract

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.

Eur J Clin Microbiol Infect Dis. 2015 Jan;34(1):109-13. doi: 10.1007/s10096-014-2217-5. Epub 2014 Jul 31.

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