TABLE 1.

Sensitivity and specificity of Kalon and Focus ELISAs for sera from culture-documented and WB-confirmed genital herpes episodes

Group no.Patient status at onsetaNo. of patientsMedian no. of days postonset (range)bKalonFocusWB sensitivity (%)e
Sensitivity (%)cSpecificity (%)dSensitivity (%)Specificity (%)
1First HSV-2 episode; HSV-1 and HSV-2 seronegative16104 (66-168)9/15 (60%)NAf14/15 (93%)NA16/16 (100%)
2First HSV-2 episode; HSV-1 seropositive, HSV-2 seronegative1481 (47-193)6/14 (43%)NA10/13 (77%)NA10/14 (71%)
3Recurrent HSV-2 episode; HSV-1 seronegative, HSV-2 seropositive3068 (11-150)30/30 (100%)NA30/30 (100%)NANA
4Recurrent HSV-1 episode; HSV-1 seropositive, HSV-2 seronegative5867 (0-541)NA58/58 (100%)NA54/58 (93%)NA
  • a Genital herpes status was determined by monoclonal antibody typing of the HSV isolate cultured from the presenting lesion. Seropositivity for HSV-1 or HSV-2 was determined at the onset of the lesion by WB. All Group 1 and 2 subjects eventually seroconverted to HSV-2 by WB.

  • b Days from presenting episode to seroconversion for patients who became positive or last available sample for those who remained seronegative.

  • c Sensitivity percent was 100 times the number of positive results for infected patients divided by the sum of the number of positive results for infected patients plus the number of negative results for infected patients. Culture status was used as the gold standard for infected persons. All infected persons had HSV-2 cultured from lesions. Sera with equivocal test results were excluded.

  • d Specificity percent was 100 times the number of negative results for uninfected patients divided by the sum of the number of negative results for uninfected patients plus the number of positive results for uninfected patients. HSV-2-uninfected status was determined by culture (HSV-1 only was isolated from the lesion) and WB (HSV-1 positive but HSV-2 negative).

  • e WB sensitivity was determined only for Groups 1 and 2 in sera drawn after the first episode. Groups 3 and 4 were preselected, in part, by WB results.

  • f NA, not available.