title: Type-specific identification of anogenital herpes simplex virus infections by use of a commercially available nucleic acid amplification test.
abstract: Herpes infections are among the most common sexually transmitted infections (STI), but diagnostic methods for genital herpes have not kept pace with the movement toward molecular testing. Here, we describe an FDA-approved molecular assay that identifies and types herpes simplex virus (HSV) infections for use in routine clinical settings. Paired samples from anogenital lesions were tested using the BD ProbeTec HSV Q(x) (HSVQ(x)) system, HSV culture and, a laboratory-developed PCR assay. Family planning, obstetrics/gynecology (OB/GYN), or sexually transmitted disease (STD) clinics in the United States served as recruitment sites. Sensitivity and specificity estimates, head-to-head comparisons, measures of agreement, and latent-class analyses were performed to provide robust estimates of performance. A total of 508 participants (174 men and 334 women) with anogenital lesions were included; 260 HSV-2 and 73 HSV-1 infections were identified. No differences in test performance based on gender, clinic type, location of the lesion, or type of lesion were observed. The sensitivity of HSV-2 detection ranged from 98.4 to 100% depending on the analytical approach, while the specificity ranged from 80.6%, compared to the less sensitive culture method, to 97.0%, compared to PCR. For HSV-1, the sensitivity and specificity ranges were 96.7 to 100% and 95.1 to 99.4%, respectively. This assay may improve our ability to accurately diagnose anogenital lesions due to herpes infection.
authors.affiliation: Indiana University School of Public Health, Bloomington, Indiana, USA. bvanderp@indiana.edu
authors.forename: Barbara
authors.initials: B
authors.lastname: Van Der Pol
authors.forename: Terri
authors.initials: T
authors.lastname: Warren
authors.forename: Stephanie N
authors.initials: SN
authors.lastname: Taylor
authors.forename: Mark
authors.initials: M
authors.lastname: Martens
authors.forename: Keith R
authors.initials: KR
authors.lastname: Jerome
authors.forename: Leandro
authors.initials: L
authors.lastname: Mena
authors.forename: Joel
authors.initials: J
authors.lastname: Lebed
authors.forename: Savita
authors.initials: S
authors.lastname: Ginde
authors.forename: Paul
authors.initials: P
authors.lastname: Fine
authors.forename: Edward W
authors.initials: EW
authors.lastname: Hook
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D006558:Herpes Genitalis / Q000175:diagnosis* / Q000821:virology; D018259:Herpesvirus 1, Human / Q000235:genetics / Q000302:isolation & purification*; D018258:Herpesvirus 2, Human / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D012680:Sensitivity and Specificity; D014481:United States; D055815:Young Adult