Treponema pallidum DNA, Qualitative Real-Time PCR

Test Code

16595

CPT Codes
87798

Preferred Specimen

0.7 mL CSF collected in a plastic sterile leak-proof container or
1 genital lesion swab collected in an Aptima® Transport Tube, M4 media, VCM medium (green-cap) tube or equivalent (UTM)

Minimum Volume

0.3 mL CSF

Instructions

⁠⁠⁠⁠⁠⁠⁠Genital lesion swab: Swab any visible lesions. Withdraw the swab without touching the skin. Immediately place the swab into the transport tube 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

Refrigerated (cold packs)

Specimen Stability

CSF
Room temperature: 7 days
Refrigerated: 14 days
Frozen: 30 days

Swab in Aptima® Transport tube
Room temperature: 21 days
Refrigerated: 14 days
Frozen: 30 days

Swab in M4, VCM (UTM)
Room temperature: Unacceptable
Refrigerated: 14 days
Frozen: 30 days

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

Transport tubes with 2 swabs • Aptima® transport tubes with non-Aptima® swabs

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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Mon-Sat; Report available: 2-3 days

Reference Range

Not detected

Clinical Significance

Detection of Treponema pallidum DNA by Real-Time PCR is a useful tool for the rapid diagnosis of primary, secondary, and tertiary syphilis.

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.