Genital Ulcer Disease Panel

Last Literature Review: March 2023 Last Update:

Aids in the diagnosis of genital ulcer disease by detection of HSV-1, HSV-2, Treponema pallidum, Chlamydia trachomatis L serovar, and Haemophilus ducreyi

There are several diseases associated with genital ulcers. This group of diseases, often referred to as genital ulcer diseases (GUDs), includes genital herpes simplex virus (HSV) infection, syphilis, lymphogranuloma venereum (LGV), and chancroid. GUDs are usually sexually transmitted and often have similar presentations, making clinical diagnosis difficult. The CDC recommends that all persons who have genital, anal, or perianal ulcers should be evaluated using laboratory testing to determine a definitive diagnosis.  Proper diagnosis is important because treatment and management strategies vary based on the causative agent.

Disease Overview

Genital HSV is the most common GUD in the United States, with HSV-2 infections making up the majority of HSV cases. The next most common GUD is syphilis. LGV and chancroid are less common but are also associated with genital ulcers. The prevalence of these diseases varies by population and geographic area. Infection by more than one etiologic agent is possible. 

Genital Ulcer DiseaseCausative Agent
Genital herpesaHSV-1 and HSV-2 (most common)
SyphilisbTreponema pallidum
ChancroidHaemophilus ducreyi
LGVChlamydia trachomatis (serovars L1, L2, or L3)

aRefer to the Herpes Simplex Virus - HSV topic for detailed information on HSV infection.

bRefer to the Treponema pallidum - Syphilis topic for detailed information on T. pallidum infection.

Test Interpretation

Analytic Sensitivity

InfectionLimit of Detection by Collection Type (Copies/mL)
HSV-1

Aptima collection kit: 80

Viral transport media: 80

HSV-2

Aptima collection kit: 320

Viral transport media: 320

T. pallidum

Aptima collection kit: 80

Viral transport media: 80

H. ducreyi

Aptima collection kit: 80

Viral transport media: 320

C. trachomatis L serovar

Aptima collection kit: 320

Viral transport media: 320

Analytic Specificity

No cross-reactivity with Bacteroides fragilis, Candida albicans, C. trachomatis H serovar, C. trachomatis I serovar, cytomegalovirus, Escherichia coli, Gardnerella vaginalis, Mycoplasma genitalium, M. hominis, Neisseria gonorrhoeae, Staphylococcus aureus, Treponema denticola, T. medium, Trichomonas vaginalis, Ureaplasma parvum, varicella-zoster virus

Results

Qualitative results are provided for each component:

  • A positive result will be reported as “Detected.”
  • A negative result will be reported as “Not Detected.”

Limitations

A negative result does not rule out the presence of PCR inhibitors in the patient specimen or test-specific nucleic acid in concentrations below this assay’s level of detection.

References