title: Rapid polymerase chain reaction assay to detect herpes simplex virus in the genital tract of women in labor.
abstract: 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.
  
  
  CONCLUSIONS
  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.
  
  
  METHODS
  II.
authors.affiliation: From the Departments of Obstetrics and Gynecology, Laboratory Medicine, Medicine, and Epidemiology, University of Washington; and the Vaccine and Infectious Diseases Institute, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Gardella
authors.forename: Meei-Li
authors.initials: ML
authors.lastname: Huang
authors.forename: Anna
authors.initials: A
authors.lastname: Wald
authors.forename: Amalia
authors.initials: A
authors.lastname: Magaret
authors.forename: Stacy
authors.initials: S
authors.lastname: Selke
authors.forename: Rhoda
authors.initials: R
authors.lastname: Morrow
authors.forename: Lawrence
authors.initials: L
authors.lastname: Corey
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D006558:Herpes Genitalis / Q000175:diagnosis*; D006801:Humans; D007743:Labor, Obstetric; D016133:Polymerase Chain Reaction; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000175:diagnosis* / Q000821:virology*; D012372:ROC Curve; D018139:Simplexvirus / Q000235:genetics / Q000302:isolation & purification*; D055815:Young Adult