TABLE 5.

CDC premarketing panel: overall two-tier specificity comparisons^a

Test kit	No. of samples or NPA
	One tier	STT		MTT
		MarDx Marblot (IgM+IgG)		BioPlex 2200 Lyme Total		Immunetics Lyme C6		Zeus borrelia VlsE1/pepC10		bioMérieux polyvalent		bioMérieux VIDAS II (M+G)
	Pos/Equ	Pos	NPA	Pos/Equ	NPA	Pos/Equ	NPA	Pos/Equ	NPA	Pos/Equ	NPA	Pos/Equ	NPA
BioPlex 2200 Lyme Total	6	0	100			1	99.5	2	98.9	2	98.9	3	98.4
Immunetics Lyme C6	6	0	100	1	99.5			2	98.9	2	98.9	2	98.9
Zeus Borrelia VlsE1/pepC10	20	0	100	2	98.9	2	98.9			5	97.4	5	97.4
bioMérieux VIDAS Lyme polyvalent	23	0	100	2	98.9	2	98.9	5	97.4			6	96.8
bioMérieux VIDAS Lyme II (lgM+IgG)	29	0	100	3	98.4	2	98.9	5	97.4	6	96.8
bioMérieux VIDAS Lyme II IgM	27	0	100	3	98.4	2	98.9	5	97.4	5	97.4
bioMérieux VIDAS Lyme II lgG	2	0	100	0	100	0	100	0	100	1	99.5

^aA total of 190 CDC clinically diagnosed Lyme disease-negative controls that tested first-tier positive/equivocal (Pos/Equ) from Table 4 were analyzed under various two-tier algorithms. STT, standardized two tier; MTT, modified two tier; NPA, negative percent agreement with CDC results [NPA = (Neg)/n]. The results for the MarDx Marblot, Immunetics Lyme C6, and bioMérieux VIDAS Lyme polyvalent tests were provided by the CDC.