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J Pediatric Infect Dis Soc. 2019 Feb 22. pii: piy133. doi: 10.1093/jpids/piy133. [Epub ahead of print]

Two-Tier Lyme Disease Serology Test Results Can Vary According to the Specific First-Tier Test Used.

Author information

1
Division of Emergency Medicine, Boston Children's Hospital, Boston, Massachusetts.
2
Department of Emergency Medicine, Alpert Medical School, Brown University, Providence, Rhode Island.
3
Department of Pediatrics, Children's Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
4
Pediatric Emergency Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin.
5
Division of Emergency Medicine, A. I. Dupont Hospital for Children, Sidney Kimmel Medical College Thomas Jefferson University, Wilmington, Delaware.
6
Division of Emergency Medicine, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
7
Department of Pathology, Massachusetts General Hospital, Boston, Massachusetts.
8
Harvard Medical School, Boston, Massachusetts.

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.

KEYWORDS:

Lyme disease; diagnostics; enzyme immunoassay; serology

PMID:
30793167
DOI:
10.1093/jpids/piy133

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