FIG 4.
SERA provided increased sensitivity in clinically defined Lyme disease cases. The SERA IgG plus IgM Lyme assay and standard two-tier testing (STTT) were performed on clinically defined Lyme disease, including 57 matched early (acute and convalescent) samples from the Centers for Disease Control (CDC) and Lyme Disease Biobank (LDB). (A and C) STTT-negative Lyme samples from both the CDC and LDB are positive by SERA giving improved sensitivity compared to STTT while retaining equivalent specificity. (A) SERA scores for the IgG panel shown for STTT-positive and STTT-negative Lyme and non-Lyme samples from the CDC and LDB separately. (IgG-negative points in red are SERA IgM positive.) (B) Sensitivity, specificity, and accuracy of SERA and STTT IgG and IgM on combined cohorts of clinically defined Lyme samples. (*, sensitivity P = 0.0112, accuracy P = 0.0107; Z-test; error, 95% CI). (D) Sensitivities and comparison significance of SERA and STTT on matched acute and convalescent early Lyme cases.