Higher C6 Enzyme Immunoassay Index Values Correlate with a Diagnosis of Noncutaneous Lyme Disease

Authors

Lise E. Nigrovic
Susan C. Lipsett
Claudia R. Molins
Gary P. Wormser, New York Medical CollegeFollow
Jonathan E. Bennett
Aris C. Garro
Michael N. Levas
Fran Balamuth
Desiree Neville
Nithya Lingampalli
William H. Robinson
John A. Branda

DOI

10.1016/j.diagmicrobio.2018.12.001

Journal Title

Diagnostic Microbiology and Infectious Disease

First Page

160

Last Page

164

Document Type

Article

Publication Date

June 2019

Department

Medicine

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.

Recommended Citation

Nigrovic, L., Lipsett, S., Molins, C., Wormser, G., Bennett, J., Garro, A., Levas, M., Balamuth, F., Neville, D., Lingampalli, N., Robinson, W., & Branda, J. (2019). Higher C6 Enzyme Immunoassay Index Values Correlate with a Diagnosis of Noncutaneous Lyme Disease. Diagnostic Microbiology and Infectious Disease, 94 (2), 160-164. https://doi.org/10.1016/j.diagmicrobio.2018.12.001