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Tropheryma whipplei (Whipple's) DNA, Qualitative, Real-Time PCR (TWDNA)
Test CodeLAB2526
Quest Code
11352
CPT Codes
87798<br /> <strong>This test is not available for New York patient testing.</strong>
Preferred Specimen
>3mm3 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)
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
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 Nichols Institute-San Juan Capistrano, CA |
33608 Ortega Highway |
San Juan Capistrano, CA 92675-2042 |