Effective April 19, 2021, Clinical Pathology Laboratories (CPL) will change the herpes simplex virus (HSV) testing methodology from culture to transcription mediated amplification (TMA). Test code 6069 will include report fields for HSV typing as that is intrinsic to the method. Test code 6068 will be deleted as redundant.

TMA with the Aptima HSV 1 & 2 Assay on the Hologic Panther System will offer:

  • Faster turnaround time
  • Improved sensitivity
  • Subtype testing on every sample

HSV infection with type 1 (HSV-1) or type 2 (HSV-2) is among the most prevalent sexually transmitted infections in the United States, with a seroprevalence of 58% for HSV-1 and 17% for HSV-2 among people 14 to 49 years old. HSV-1 most often causes oral herpes and HSV-2 most often causes genital herpes, however HSV-1 is increasingly responsible for genital infections.

Following infection, lesions first appear between days 2 and 14 (most often between days 4 and 7). Virus is detectable by either viral culture or nucleic acid amplification test (NAAT) when lesions are present. However, viral culture has lower sensitivity that decreases as the lesions heal and is particularly lower for recurrent lesions. NAAT based assays are 2 to 4-times more sensitive and therefore preferred for diagnosing infection.

Diagnosing infection and determining HSV type can indicate the relative risk of recurrence, transmission risks, and prognosis. Therefore, typing will be performed and reported on all samples. While establishment of the HSV type may be epidemiologically useful for patient counseling, it does not generally affect the choice of treatment. A negative result does not necessarily indicate absence of infection since viral shedding is intermittent. This testing does not detect Varicella Zoster virus (VZV) which may produce similar clinical findings. If VZV is a clinical consideration, separate VZV testing may be performed on the same sample.

This change in methodology may result in a pricing adjustment. Please contact your Account Representative for new pricing information.

Order Unit Code: 6069 - Herpes Simplex Virus TMA
Test Method: Target capture, transcription-mediated amplification (TMA)
Specimen Requirements: Preferred: Clinician-collected swab specimens from anogenital lesions or other cutaneous lesions placed in viral transport media (VTM) (Refrigerated Transport).
Specimen Rejection Criteria: Samples received without a swab; samples received with 2 swabs; samples received in media other than VTM or Aptima Specimen Transfer Tube; CSF; tissue; calcium alginate swabs; swabs with wooden shafts; swabs in gel-containing transport media.
Transport Temperature: Refrigerated
Stability: 3 days refrigerated; 7 days frozen
Specimen Retention: 2 weeks
Performed: Monday through Friday
Analytic Time: 1-2 days
Reference Range: Negative
CPT Codes: 87529