TABLE 3.

Study II: comparison of rNon-OspA ELISA and Vidas immunoassay for sensitivity and specificity (performed at site B)^a

Clinical diagnostic	No. of samples	No.positive/no. negative (%) by ELISA with:
		rNon-OspA	Vidasb
Early Lyme disease, culture positive	65	56/9 (86)	56/9 (86)
Disseminated Lyme disease (arthritis, PCR positive)	10	10/0 (100)	8/2 (80)
Syphilis	6	1/5 (17)	3/3 (50)
Autoimmune disease	20	6/14 (30)	1/19 (5)
Healthy	19	2/17 (10)	0/19 (0)

^aNote: values of ≥3 standard deviations were counted as positive.

^bCDC 1st tier; P > 0.05 for all panels tested by McNemar’s exact test for correlated proportions.