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

  1. Lise E. Nigrovic1
  1. 1Division of Emergency Medicine
  2. 2Division of General Pediatrics
  3. 3Department of Laboratory Medicine, Boston Children's Hospital
  4. 4Department of Pathology, Massachusetts General Hospital, Boston
  5. 5Pediatric Physicians’ Organization at Children's, Brookline, Massachusetts
  1. Correspondence: S. C. Lipsett, Division of Emergency Medicine, Boston Children's Hospital, 300 Longwood Ave, Boston, MA 02115 (susan.lipsett{at}childrens.harvard.edu).

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.

Key words

  • Received April 26, 2016.
  • Accepted June 20, 2016.
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