TABLE 2.

Performance of HSV-2 serological assays compared to those of serological (MAb-EIA) and clinicovirological reference standards in Brazila

AssayPerformance indicators against MAb-EIA (n = 577)bPerformance indicators against clinicovirological standard (n = 280)c
No. of samples positive/no. tested (%)% Sensitivity (95% CI)% Specificity (95% CI)No. of samples positive/no. tested (%)% Sensitivity (95% CI)% Specificity (95% CI)
MAb-EIA143/577 (24.8)NANA30/278 (10.8)86.7 (69-96)98.4 (96-100)
Kalon145/566 (25.6)93.5 (88-97)96.5 (94-98)38/280 (13.6)100 (88-100)96.8 (94-99)
HerpeSelect (CO > 1.1)172/519 (33.1)93.8 (88-97)86.9 (83-90)43/262 (16.4)100 (88-100)94.0 (90-97)
HerpeSelect (CO > 3.5)111/519 (21.4)81.4 (74-88)98.5 (97-99)28/262 (10.7)89.7 (73-98)99.1 (97-100)
  • a CO, cutoff; NA, not applicable.

  • b The MAb-EIA reference standard comprised 143 positive and 434 negative samples, after the exclusion of 8 samples with equivocal results.

  • c clinicovirological reference standard comprised samples from AIDS patients with HSV-2 ulcers (group 1) considered positive (n = 30) and children <2 years of age (group 6) considered negative (n = 250).