Rapid polymerase chain reaction assay to detect herpes simplex virus in the genital tract of women in labor

Obstet Gynecol. 2010 Jun;115(6):1209-1216. doi: 10.1097/AOG.0b013e3181e01415.


Objective: To develop a rapid quantitative real-time polymerase chain reaction (PCR) to detect herpes simplex virus (HSV) in the genital secretions of women that may be used in labor.

Methods: Samples of genital secretions from women in labor, swabs of active genital lesions, and swabs of buffer solution were analyzed using a newly developed rapid HSV PCR assay to detect HSV glycoprotein B gene and quantitate virion copy number. A previously validated TaqMan PCR to detect HSV glycoprotein B gene was performed as the comparator gold standard. Positivity determination that optimized sensitivity and specificity was determined with receiver operating characteristic curves.

Results: The median time to result for rapid HSV PCR was 2 hours (range 1.5-3.5 hours). A positivity determination rule that required both wells of the rapid test to detect 150 copies or greater of HSV per milliliter maximized specificity (96.7%) without appreciable loss of sensitivity (99.6%). Among positive samples, the correlation between the rapid test and TaqMan for the quantity of HSV isolated was excellent (R=0.96, P<.001). The rapid test had a positive predictive value of 96.7% and a negative predictive value of 99.6% in a population with HSV shedding prevalence of 10.8%, based on the prevalence of genital HSV previously found among HSV-2 seropositive women in labor.

Conclusion: Rapid HSV PCR provides results with excellent sensitivity and specificity within a timeframe that could inform clinical decision making for identifying neonates at risk of neonatal HSV infection.

Level of evidence: II.

Publication types

  • Evaluation Study
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Adult
  • Female
  • Herpes Genitalis / diagnosis*
  • Humans
  • Labor, Obstetric
  • Polymerase Chain Reaction
  • Pregnancy
  • Pregnancy Complications, Infectious / diagnosis*
  • Pregnancy Complications, Infectious / virology*
  • ROC Curve
  • Simplexvirus / genetics
  • Simplexvirus / isolation & purification*
  • Young Adult