Diagnostic microbiology and infectious disease · 2018
Higher C6 enzyme immunoassay index values correlate with a diagnosis of noncutaneous Lyme disease.
Оценочное исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Nigrovic Lise E, Lipsett Susan C, Molins Claudia R, Wormser Gary P, Bennett Jonathan E, Garro Aris C, Levas Michael N, Balamuth Fran, Neville Desiree, Lingampalli Nithya, Robinson William H, Branda John A
Аннотация
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.