TABLE 6.

Agreement of results of HISCL anti-TP assay or Lumipulse G TP-N and those of applied testing algorithms^a

Assay and result	No. agreed/no. total	Agreement (% [95% CI])	Kappa value
HISCL anti-TP
Overall agreement	1,078/1,078b	100 (99.56–100)	1.0
Positive agreement	323/323c	100 (98.53–100)
Negative agreement	755/755d	100 (99. 37–100)
Lumipulse G TP-N
Overall agreement	1,074/1,078b	99.63 (98.98–99.88)	0.99
Positive agreement	323/323c	100 (98.53–100)
Negative agreement	751/755d	99.47 (98.55–99.83)

^aSee Fig. 1.

^bA total of 1,082 samples were tested in this study, and 4 samples that had indeterminate immunoblot results were excluded.

^cThe total number of positive samples consisted of 300 preselected syphilis-positive samples, 1 confirmed positive sample from the potentially interfering group, and 22 confirmed positive samples from the borderline group.

^dThe total number of negative samples consisted of 704 syphilis-negative samples, 47 confirmed negative samples from the potentially interfering group, and 4 confirmed negative samples from the borderline group.