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Clin Infect Dis. 2016 Oct 1;63(7):922-8. doi: 10.1093/cid/ciw427. Epub 2016 Jun 28.

Evaluation of the C6 Lyme Enzyme Immunoassay for the Diagnosis of Lyme Disease in Children and Adolescents.

Author information

1
Division of Emergency Medicine.
2
Department of Pathology, Massachusetts General Hospital, Boston.
3
Department of Laboratory Medicine, Boston Children's Hospital.
4
Division of General Pediatrics Pediatric Physicians' Organization at Children's, Brookline, Massachusetts.

Abstract

BACKGROUND:

The commercially-available C6 Lyme enzyme immunoassay (EIA) has been approved to replace the standard whole-cell sonicate EIA as a first-tier test for the diagnosis of Lyme disease and has been suggested as a stand-alone diagnostic. However, the C6 EIA has not been extensively studied in pediatric patients undergoing evaluation for Lyme disease.

METHODS:

We collected discarded serum samples from children and adolescents (aged ≤21 years) undergoing conventional 2-tiered testing for Lyme disease at a single hospital-based clinical laboratory located in an area endemic for Lyme disease. We performed a C6 EIA on all collected specimens, followed by a supplemental immunoblot if the C6 EIA result was positive but the whole-cell sonicate EIA result was negative. We defined a case of Lyme disease as either a clinician-diagnosed erythema migrans lesion or a positive standard 2-tiered serologic result in a patient with symptoms compatible with Lyme disease. We then compared the performance of the C6 EIA alone and as a first-tier test followed by immunoblot, with that of standard 2-tiered serology for the diagnosis of Lyme disease.

RESULTS:

Of the 944 specimens collected, 114 (12%) were from patients with Lyme disease. The C6 EIA alone had sensitivity similar to that of standard 2-tiered testing (79.8% vs 81.6% for standard 2-tiered testing; P = .71) with slightly lower specificity (94.2% vs 98.8% 2; P < .002). Addition of a supplemental immunoblot improved the specificity of the C6 EIA to 98.6%.

CONCLUSIONS:

For children and adolescents undergoing evaluation for Lyme disease, the C6 EIA could guide initial clinical decision making, although a supplemental immunoblot should still be performed.

KEYWORDS:

C6; Lyme disease; Lyme disease diagnostics; pediatrics

PMID:
27358358
PMCID:
PMC5019286
DOI:
10.1093/cid/ciw427
[Indexed for MEDLINE]
Free PMC Article

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