The Lyme Disease Polymerase Chain Reaction Test Has Low Sensitivity.

TitleThe Lyme Disease Polymerase Chain Reaction Test Has Low Sensitivity.
Publication TypeJournal Article
Year of Publication2019
AuthorsNigrovic LE, Lewander DP, Balamuth F, Neville DN, Levas MN, Bennett JE, Garro A
JournalVector Borne Zoonotic Dis
Date Published2019 Dec 10
ISSN1557-7759
Abstract

The Lyme PCR is a direct detection test, but has not been rigorously evaluated in children undergoing evaluation for acute Lyme disease. We performed a six-center prospective cohort study of children aged 1 to 21 years undergoing acute evaluation for Lyme disease. For this planned secondary analysis, we limited our cohort to children undergoing evaluation for Lyme disease who had any Lyme PCR test obtained by a treating clinician (blood, synovial fluid, or cerebrospinal fluid). We defined a case of Lyme disease with a positive two-tier Lyme disease serology: a positive or equivocal enzyme immunoassay followed by a positive supplemental immunoblot interpreted using standard criteria. We report the test characteristics of Lyme PCR for the diagnosis of Lyme disease. We identified 124 children of whom 54 (43.5%) had Lyme disease. Overall, 23 had a positive PCR test (sensitivity 41.8%; 95% confidence interval [CI] 29.7-55.0; specificity 100%, 95% CI: 94.2-100). All children with a positive Lyme PCR also had a positive two-tiered Lyme disease serology. The Lyme disease PCR test did not improve the diagnosis of children undergoing evaluation for acute Lyme disease. Given the additional costs of this low utility test, clinicians should not order Lyme PCR testing in the acute care setting.

DOI10.1089/vbz.2019.2547
Alternate JournalVector Borne Zoonotic Dis.
PubMed ID31821110