Sexually-Transmitted Infections (STIs) Genital Lesion Panel

Test Code

38286

CPT Codes
87529 (x2), 87798 CPT coding may differ dependent on payer rules which may impact prior authorization testing. Please direct any questions regarding CPT coding to the payer being billed.

Includes

SureSwab®, Herpes Simplex Virus, Type 1 and 2 mRNA,TMA
Treponema pallidum DNA, Qualitative Real-Time PCR

Preferred Specimen

1 genital lesion swab collected in an Aptima® Multitest Transport Tube

Instructions

Swab any visible lesions. Withdraw the swab without touching the skin. Immediately place the swab into the Aptima® Multitest Transport Tube (orange label) so that the tip of the swab is visible below the tube label. Carefully break the swab shaft at the score line against the side of the tube and discard the top portion of the swab shaft. Tightly screw the cap onto the tube.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 21 days
Refrigerated: 28 days
Frozen: 30 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Transport tubes with 2 swabs • Transport tubes with non-Aptima® swabs • Swab submitted in viral transport media • Aptima® Unisex collection kit (white label)

Methodology
Real-Time Polymerase Chain Reaction

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Mon-Sat; Report available: 4-6 days

Reference Range

HSV 1	Not Detected
HSV 2	Not Detected
T. pallidum DNA, QL Real Time PCR	Not Detected

Clinical Significance

This panel includes nucleic acid amplification testing for HSV-1, HSV-2, and Treponema pallidum in genital lesion swabs. Due to the overlapping clinical presentation of herpetic and syphilitic lesions, this panel can be used to aid in the identification of the most common etiological agents causing genital ulcer disease. A positive result is definitive diagnosis for the causative agent and a negative result may require additional testing.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.