TABLE 6

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

Assay and resultNo. agreed/no. totalAgreement (% [95% CI])Kappa value
HISCL anti-TP
    Overall agreement1,078/1,078b100 (99.56–100)1.0
    Positive agreement323/323c100 (98.53–100)
    Negative agreement755/755d100 (99. 37–100)
Lumipulse G TP-N
    Overall agreement1,074/1,078b99.63 (98.98–99.88)0.99
    Positive agreement323/323c100 (98.53–100)
    Negative agreement751/755d99.47 (98.55–99.83)
  • a See Fig. 1.

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

  • c The 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.

  • d The 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.