TABLE 3

Performance of illumigene HSV 1&2 assay compared to that of ELVIS culture

AnalyteSiteNo. TPaNo. TNbNo. FPNo. FNTotal no.Sensitivity (%) (95% CI)Specificity (%) (95% CI)
HSV-1A9380047100 (63–100)100 (88–100)
B6421711129398.5 (91–100)95.2 (91–97)
C961227481.8 (48–97)96.8 (88–99)
D5214760205100 (91–100)96.1 (91–98)
E3417314722882.9 (67–92)92.5 (88–96)
F1140015100 (5–100)100 (73–100)
G31791111296.9 (82–100)98.8 (92–100)
Total2007293411974c94.8 (91–97)95.5 (94–97)
HSV-2A20452067100 (80–100)95.7 (84–99)
B70281120363100 (94–100)95.9 (93–98)
C16686090100 (76–100)91.9 (82–97)
D3819960243100 (88–100)97.1 (93–99)
E2421414225492.3 (73–99)93.8 (90–96)
F2150017100 (20–100)100 (75–100)
G710840119100 (56–100)96.4 (90–99)
Total1779304421,153d98.9 (96–100)95.5 (94–97)
  • a TP, true positive.

  • b TN, true negative.

  • c HSV-2 ELVIS-positive specimens were removed from HSV-1 analysis, as positive HSV-2 cells are not tested for HSV-1 coinfection following the ELVIS protocol.

  • d Two specimens were invalid after a repeat test.