Thirteen studies examined a two-tier serological test protocol vs.

Included in the review are 48 studies on diagnostic tests used in North America published since 1995. The objective of this systematic review is to summarize the North American evidence on the accuracy of diagnostic tests and test regimes at various stages of LD. There are many diagnostic tests for LD available in North America, all of which have some performance issues, and physicians are concerned about the appropriate use and interpretation of these tests. There has been an increasing incidence of Lyme disease (LD) in Canada and the United States corresponding to the expanding range of the Ixodes tick vector and Lyme disease agent ( Borrelia burgdorferi sensu stricto).