Diagnostic Performance of C6 Enzyme Immunoassay for Lyme Arthritis.

Item request has been placed! ×
Item request cannot be made. ×
loading   Processing Request
Read More Add to Saved list
  • Additional Information
    • Corporate Authors:
      PEDI LYME NET
    • Source:
      Publisher: American Academy of Pediatrics Country of Publication: United States NLM ID: 0376422 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1098-4275 (Electronic) Linking ISSN: 00314005 NLM ISO Abbreviation: Pediatrics Subsets: MEDLINE
    • Publication Information:
      Publication: Elk Grove Village Il : American Academy of Pediatrics
      Original Publication: Springfield, Ill., Thomas.
    • Subject Terms:
      Clinical Enzyme Tests/*methods ; Lyme Disease/*diagnosis; Acute Disease ; Arthritis, Infectious/diagnosis ; Arthritis, Infectious/epidemiology ; Arthrocentesis/statistics & numerical data ; Blood Sedimentation ; Borrelia burgdorferi/immunology ; C-Reactive Protein/analysis ; Child ; Child, Preschool ; Diagnosis, Differential ; Female ; Humans ; Immunoblotting ; Immunoglobulin G/blood ; Immunoglobulin M/blood ; Infant ; Lyme Disease/epidemiology ; Male ; Prospective Studies ; Sensitivity and Specificity
    • Abstract:
      Objectives: In Lyme disease endemic areas, initial management of children with arthritis can be challenging because diagnostic tests take several days to return results, leading to potentially unnecessary invasive procedures. Our objective was to examine the role of the C6 peptide enzyme immunoassay (EIA) test to guide initial management.
      Methods: We enrolled children with acute arthritis undergoing evaluation for Lyme disease presenting to a participating Pedi Lyme Net emergency department (2015-2019) and performed a C6 EIA test. We defined Lyme arthritis with a positive or equivocal C6 EIA test result followed by a positive supplemental immunoblot result and defined septic arthritis as a positive synovial fluid culture result or a positive blood culture result with synovial fluid pleocytosis. Otherwise, children were considered to have inflammatory arthritis. We report the sensitivity and specificity of the C6 EIA for the diagnosis of Lyme arthritis.
      Results: Of the 911 study patients, 211 children (23.2%) had Lyme arthritis, 11 (1.2%) had septic arthritis, and 689 (75.6%) had other inflammatory arthritis. A positive or equivocal C6 EIA result had a sensitivity of 100% (211 out of 211; 95% confidence interval [CI]: 98.2%-100%) and specificity of 94.2% (661 out of 700; 95% CI: 92.5%-95.9%) for Lyme arthritis. None of the 250 children with a positive or equivocal C6 EIA result had septic arthritis (0%; 95% CI: 0%-1.5%), although 75 children underwent diagnostic arthrocentesis and 27 underwent operative joint washout.
      Conclusions: In Lyme disease endemic areas, a C6 EIA result could be used to guide initial clinical decision-making, without misclassifying children with septic arthritis.
      Competing Interests: POTENTIAL CONFLICT OF INTEREST: Dr Branda has received research funding from Alere, bioMerieux, DiaSorin, and Immunetics, and he is a paid consultant to AdvanDx, Diasorin, and T2 Biosystems; the other authors have indicated they have no potential conflicts of interest to disclose.
      (Copyright © 2020 by the American Academy of Pediatrics.)
    • Comments:
      Comment in: Pediatrics. 2020 Jan;145(1):. (PMID: 31836616)
    • Accession Number:
      0 (Immunoglobulin G)
      0 (Immunoglobulin M)
      9007-41-4 (C-Reactive Protein)
    • Publication Date:
      Date Created: 20191215 Date Completed: 20200408 Latest Revision: 20200408
    • Publication Date:
      20231215
    • Accession Number:
      10.1542/peds.2019-0593
    • Accession Number:
      31836615