Faculty Collaboration Database

Two-Tier Lyme Disease Serology Test Results Can Vary According to the Specific First-Tier Test Used. J Pediatric Infect Dis Soc 2020 Apr 30;9(2):128-133

Date

02/23/2019

Pubmed ID

30793167

DOI

10.1093/jpids/piy133

Scopus ID

2-s2.0-85076961196 (requires institutional sign-in at Scopus site)   10 Citations

Abstract

BACKGROUND: Variability in 2-tier Lyme disease test results according to the specific first-tier enzyme immunoassay (EIA) in children has not been examined rigorously. In this study, we compared paired results of clinical 2-tier Lyme disease tests to those of the C6 peptide EIA followed by supplemental immunoblotting (C6 2-tier test).

METHODS: We performed a prospective cohort study of children aged ≥1 to ≤21 years who were undergoing evaluation for Lyme disease in the emergency department at 1 of 6 centers located in regions in which Lyme disease is endemic. The clinical first-tier test and a C6 EIA were performed on the same serum sample with supplemental immunoblotting if the first-tier test result was either positive or equivocal. We compared the results of the paired clinical and C6 2-tier Lyme disease test results using the McNemar test.

RESULTS: Of the 1714 children enrolled, we collected a research serum sample from 1584 (92.4%). The clinical 2-tier EIA result was positive in 316 (19.9%) children, and the C6 2-tier test result was positive or equivocal in 295 (18.6%) children. The clinical and C6 2-tier test results disagreed more often than they would have by chance alone (P = .002). Of the 39 children with either a positive clinical or C6 2-tier test result alone, 2 children had an erythema migrans (EM) lesion, and 29 had symptoms compatible with early disseminated Lyme disease.

CONCLUSIONS: Two-tier Lyme disease test results differed for a substantial number of children on the basis of the specific first-tier test used. In children for whom there is a high clinical suspicion for Lyme disease and who have an initially negative test result, clinicians should consider retesting for Lyme disease.

Author List

Maulden AB, Garro AC, Balamuth F, Levas MN, Bennett JE, Neville DN, Branda JA, Nigrovic LE

Author

Michael Levas MD Professor in the Pediatrics department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adolescent
Child
Child, Preschool
Endemic Diseases
False Negative Reactions
Female
Humans
Immunoenzyme Techniques
Infant
Lyme Disease
Male
Prospective Studies
Sensitivity and Specificity
Serologic Tests
Young Adult