Syphilis (Treponema pallidum DNA), Qualitative Real-Time PCR
Test code
CPT code(s)*
Clinical significance
Test resources
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.
Specimen requirements | |
|---|---|
| Patient preparation | None Specified |
| 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 |
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.
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