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Higher C6 enzyme immunoassay index values correlate with a diagnosis of noncutaneous Lyme disease. Diagn Microbiol Infect Dis 2018 Dec 08 PMID: 30642722

Pubmed ID

30642722

DOI

10.1016/j.diagmicrobio.2018.12.001

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.

Author List

Nigrovic LE, Lipsett SC, Molins CR, Wormser GP, Bennett JE, Garro AC, Levas MN, Balamuth F, Neville D, Lingampalli N, Robinson WH, Branda JA

Author

Michael Levas MD Associate Professor in the Pediatrics department at Medical College of Wisconsin




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