Higher C6 enzyme immunoassay index values correlate with a diagnosis of noncutaneous Lyme disease.

TitleHigher C6 enzyme immunoassay index values correlate with a diagnosis of noncutaneous Lyme disease.
Publication TypeJournal Article
Year of Publication2019
AuthorsNigrovic LE, Lipsett SC, Molins CR, Wormser GP, Bennett JE, Garro AC, Levas MN, Balamuth F, Neville D, Lingampalli N, Robinson WH, Branda JA
JournalDiagn Microbiol Infect Dis
Volume94
Issue2
Pagination160-164
Date Published2019 Jun
ISSN1879-0070
KeywordsComplement C6, Humans, Immunoenzyme Techniques, Lyme Disease, ROC Curve, Sensitivity and Specificity, Serologic Tests
Abstract

The correlation between the Food and Drug Administration-cleared C6 enzyme immunoassay (EIA) C6 index values and a diagnosis of Lyme disease has not been examined. We used pooled patient-level data from 5 studies of adults and children with Lyme disease and control subjects who were tested with the C6 EIA. We constructed a receiver operating characteristic curve using regression clustered by study and measured the area under the curve (AUC) to examine the accuracy of the C6 index values in differentiating between patients with noncutaneous Lyme disease and control subjects. In the 4821 included patients, the C6 index value had excellent ability to distinguish between patients with noncutaneous Lyme disease and control subjects [AUC 0.99; 95% confidence interval (CI) 0.99-1.00]. An index value cut point of ≥3.0 had a sensitivity of 90.9% (95% CI, 87.8-93.3) and specificity of 99.0% (95% CI, 98.6-99.2%) for Lyme disease.

DOI10.1016/j.diagmicrobio.2018.12.001
Alternate JournalDiagn. Microbiol. Infect. Dis.
PubMed ID30642722