Title

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

Year of Publication

2019

Number of Pages

160-164

Date Published

2019 Jun

ISSN Number

1879-0070

Abstract

<p>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.</p>

DOI

10.1016/j.diagmicrobio.2018.12.001

Alternate Title

Diagn. Microbiol. Infect. Dis.

PMID

30642722

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