TABLE 2

Comparison of Amplivue HSV 1+2 assay with ELVIS culture for detection of HSV-2 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
    Positive20648254
    Negative51,0771,082
    Total2111,1251,33697.6 (94.6–99.0)d95.7 (94.4–96.8)81.1 (75.8–85.4)99.5 (98.9–99.8)15.896.0
After discordant-result analysisa
    Positive2433246
    Negative21,0801,082
    Total2451,0831,32899.2 (97.1–99.8)99.7 (99.2–99.9)98.8 (96.5–99.6)99.8 (99.3–99.9)18.499.6
  • a Eight of the 53 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.