TABLE 4

Performance of illumigene HSV 1&2 assay based on site of lesion

LocationAnalyteNo. TPNo. TNNo. FPNo. FNTotalSensitivity (%) (95% CI)Specificity (%) (95% CI)
Genitala (cutaneous)HSV-1663127275.0 (41–93)98.4 (92–100)
HSV-220648092100 (84–100)88.9 (80–94)
Skin lesionHSV-1421445119297.7 (88–100)96.6 (92–99)
HSV-22218750214100 (85–100)97.4 (94–99)
Genitalb (mucocutaneous)HSV-19337617749393.0 (86–97)95.7 (93–97)
HSV-212846727162399.2 (96–100)94.5 (92–96)
OralHSV-1448190134100 (92–100)90.0 (82–95)
HSV-20132211350.0 (0–79)98.5 (95–100)
AnorectalHSV-17330040100 (65–100)100 (90–100)
HSV-27372046100 (65–100)94.9 (83–99)
NasalHSV-1891018100 (68–100)90.0 (60–98)
HSV-20180018NAc100 (82–100)
OcularHSV-101901200.0 (0–79)100 (83–100)
HSV-20200020NA100 (84–100)
UrethralHSV-104105NA80.0 (38–96)
HSV-205005NA100 (57–100)
  • a Penile.

  • b Vaginal/cervical.

  • c NA, not available.