Syphilis (Treponema pallidum DNA), Qualitative Real-Time PCR

Syphilis (Treponema pallidum DNA), Qualitative Real-Time PCR

Test Code

16595
87798
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
16595
87798
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
In-home collection is not available in your area through Quest Mobile.

Clinical Significance

Syphilis (Treponema pallidum DNA), Qualitative Real-Time PCR - The Syphilis (Treponema pallidum) DNA, Qualitative Real-Time PCR is a molecular assay used for the direct detection of T. pallidum nucleic acid (DNA) in patient specimens to aid in the diagnosis of syphilis. Moist lesion (exudate) specimens collected during primary (and possibly secondary) syphilis can be tested in seronegative patients. Neonatal cerebral spinal fluid (CSF) can also be considered for testing as part of the laboratory evaluation in suspected cases of congenital syphilis. There is insufficient data to guide recommendations in suspected cases of adult neurosyphilis.
Molecular testing ...

Test Resources

Clinical Focus

Syphilis: Laboratory Support for Screening, Diagnosis, and Monitoring

Test Details

Methodology

Real-Time Polymerase Chain Reaction

Assay Category

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.

Reference Range(s)

Not detected

LOINC® Codes, Performing Laboratory

Service Area must be determined

Methodology

Real-Time Polymerase Chain Reaction
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.

Reference Range(s)

Not detected
Service Area must be determined

Preferred Specimen(s)

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

Collection 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

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

Setup Schedule

Service Area must be determined
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)
0.3 mL CSF
⁠⁠⁠⁠⁠⁠⁠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.
Refrigerated (cold packs)
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
Transport tubes with 2 swabs • Aptima® transport tubes with non-Aptima® swabs
Service Area must be determined
In-home collection is not available in your area through Quest Mobile.
Test Details

Clinical Significance

Test Resources

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

The tests listed by specialty and category are a select group of tests offered. For a complete list of Quest Diagnostics tests, please adjust the filter options chosen, or refer to our Directory of Services.

Customize the test information for your Service Area