TABLE 1

Comparison of AmpliVue HSV 1+2 assay with ELVIS culture for detection of HSV-1 before and after discordant-result analysisa

AmpliVue HSV 1+2 assay resultNo. of ELVIS culture results% Sensitivity% Specificity% PPVb% NPVc% Prevalence% Total agreement
PositiveNegativeTotal
Before discordant-result analysis
    Positive17934213
    Negative81,1151,123
    Total1871,1491,33695.7 (91.8–97.8)d97.0 (95.9–97.9)84.0 (78.5–88.3)99.3 (98.6–99.6)14.096.9
After discordant-result analysisa
    Positive2083211
    Negative21,1211,123
    Total2101,1241,33499.0 (96.6–99.7)99.7 (99.2–99.9)98.6 (95.9–99.5)99.8 (99.4–100.0)15.799.6
  • a Two of the 42 discordant specimens could not be tested because of insufficient volume. Discordant-result analysis was performed by using alternative molecular methods (Lyra HSV 1+2/VZV) and bidirectional sequencing.

  • b PPV, positive predictive value.

  • c NPV, negative predictive value.

  • d Each value in parentheses is the 95% confidence interval.