Tropheryma whipplei (Whipple's) DNA, Qualitative, Real-Time PCR (TWDNA)

Test Code
LAB2526

Quest Code
11352

CPT Codes
87798<br /> <strong>This test is not available for New York patient testing.</strong>

Preferred Specimen
>3mm tissue biopsy or 0.7 mL CSF or 0.7 whole blood collected in an EDTA (lavender-top) or ACD (yellow-top) tube

Minimum Volume
3 mm3 frozen tissue • 0.3 mL CSF or whole blood

Instructions
Do not freeze whole blood

Transport Container
See Preferred Specimen(s)

Transport Temperature
Tissue: Frozen
CSF and whole blood: Refrigerated (cold packs)

Specimen Stability
Tissue and CSF
Room temperature: 48 hours
Refrigerated: 7 days
Frozen: 30 days

Whole blood
Room temperature: 48 hours
Refrigerated: 7 days
Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Received room temperature • Frozen whole blood

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.

This test is not available for New York patient testing.

Setup Schedule
Monday-sunday

Reference Range
Not detected

Clinical Significance
Tropheryma whipplei (Whipple's disease) DNA,  PCR is a highly sensitive and specific method to detect the presence of Tropheryma whipplei DNA in clinical specimens. The diagnosis of Tropheryma whipplei infection should not rely solely upon the result of a PCR assay. A positive result should be considered in conjunction with clinical presentation and additional established clinical tests. Moreover, this assay cannot differentiate between viable and nonviable organisms. A negative PCR result indicates the absence of Tropheryma whipplei DNA at detectable levels in the samples tested and does not exclude the diagnosis of disease.

Performing Laboratory
Quest Diagnostics Infectious Disease, Inc.
33608 Ortega Highway, Bldg B-West Wing
San Juan Capistrano, CA 92675-2042




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.