Molecular diagnosis of Lyme disease: Review and meta-analysis

The diagnosis of Lyme disease is difficult because tests that reflect activ e disease or have reasonable sensitivity and specificity are lacking or not timely. Molecular methods are controversial because of differences in assa ys, gene targets, and limited clinical validation. This review summarizes p ublished assays for Lyme disease diagnosis using skin, plasma, synovial flu id, cerebrospinal fluid (CSF), and urine. Meta-analyses show the strengths and weaknesses of these methods. Overall, assays for skill and synovial flu id (68% and 73%, respectively) have high sensitivity and uniformity. The lo w rest sensitivity of CSF (18%) and plasma (29%), variable sensitivities am ong CSF and urine assays, and persistence of Borrelia burgdorferi DNA in ur ine and synovial fluid even with therapy and convalescence make these unsui table for primary diagnosis. Molecular assays for Lyme disease are best use d with other diagnostic methods and only in situations in which the clinica l probability of Lyme disease is high.