Treponema Pallidum DNA, Qualitative, Real-Time PCR
Test Summary
Detection of Treponema pallidum DNA by Real-Time PCR is a useful tool for the rapid diagnosis of primary, secondary, and tertiary syphilis.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
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.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Refrigerated
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
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
Transport tubes with 2 swabs • Aptima® transport tubes with non-Aptima® swabs
Order Code
TPALQL
EPIC (Premier) Code
LAB867
Includes
N/A
CPT Code
- 86777
- 86778
- 86762
- 86645
- 86694
Billing Code
- 670735
CPT Statement
Methodology
Real-Time Polymerase Chain Reaction (RT-PCR)
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.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675
33608 Ortega Highway
San Juan Capistrano CA, 92675
Department
Reference Testing
Reference Range
Not detected
Setup Schedule / Expected Turnaround Time
Monday - Saturday; Report available: 2 - 3 days
Specimen Collection
Special Instructions
N/A
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.
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Refrigerated
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
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
Transport tubes with 2 swabs • Aptima® transport tubes with non-Aptima® swabs
Result Information
Methodology
Real-Time Polymerase Chain Reaction (RT-PCR)
Testing Laboratory
N/A
Reference Range
Not detected
Setup Schedule / Expected Turnaround Time
Monday - Saturday; Report available: 2 - 3 days