Utility of Whole Blood Real-Time PCR Testing for the Diagnosis of Early Lyme Disease.

Abstract

Whole blood real-time polymerase chain reaction (WB-RTPCR) detection of Borrelia burgdorferi is not currently recommended for diagnosing Lyme disease. This study aims to elucidate the utility of WB-RTPCR as a diagnostic aid for early Lyme disease (ELD), defined as either positive PCR or positive immunoglobulin M with negative immunoglobulin G immunoblot. A retrospective analysis was performed on 33,199 blood specimens evaluated concurrently by WB-RTPCR and antibody-capture serology (ACEIA) methods (group A). Fifty-six pairs of specimens from a separate data set were retrospectively identified and analyzed at initial and follow-up time points to monitor for seroconversion (group B). Also, a separate data set of 2,526 specimens concurrently assessed by molecular and modified two-tiered enzyme-linked immunosorbent assay serology methods was analyzed (group C). Group A yielded 1,379 specimens consistent with ELD when tested by ACEIA and WB-RTPCR. In total, 131 (9.5% of positive results) were identified by WB-RTPCR, with negative serology. Group C identified 358 samples compatible with ELD, with 31 (8.7% of positive results) identified by RTPCR alone. When used concurrently with serologic testing, WB-RTPCR testing increases diagnostic sensitivity in cases of ELD.