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

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

Test Code

11352
87798
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
11352
87798
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
Ordering Restrictions may apply. Please provide SERVICE AREA INFORMATION to find available tests you can order.
Please provide SERVICE AREA INFORMATION to confirm Test Code for the lab that services your account.
In-home collection is not available in your area through Quest Mobile.

Clinical Significance

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

Test Resources

None found for this test
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Test Details

Methodology

Real-Time Polymerase Chain Reaction (RT-PCR)

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.

This test is not available for New York patient testing.

Reference Range(s)

Not detected

Alternative Name(s)

Whipple's Disease

LOINC® Codes, Performing Laboratory

Service Area must be determined

Methodology

Real-Time Polymerase Chain Reaction (RT-PCR)
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.

Reference Range(s)

Not detected

Alternative Name(s)

Whipple's Disease
Service Area must be determined

Preferred Specimen(s)

>3 mm3 fresh tissue submitted in a sterile, leak-proof container

Alternative Specimen(s)

0.7 mL CSF or synovial fluid submitted in a sterile, leak-proof container • 0.7 mL whole blood collected in an EDTA (lavender-top) tube

Minimum Volume

3 mm3 tissue • 0.3 mL CSF, whole blood, or synovial fluid

Transport Container

Sterile, leak-proof container • EDTA (lavender-top) tube

Transport Temperature

Frozen

Specimen Stability

  • Tissue and synovial fluid
    Room temperature: Unacceptable
    Refrigerated: 7 days
    Frozen: 30 days

    Whole blood and CSF
    Room temperature: 48 hours
    Refrigerated: 7 days
    Frozen: 30 days

Setup Schedule

Service Area must be determined
>3 mm3 fresh tissue submitted in a sterile, leak-proof container
0.7 mL CSF or synovial fluid submitted in a sterile, leak-proof container • 0.7 mL whole blood collected in an EDTA (lavender-top) tube
3 mm3 tissue • 0.3 mL CSF, whole blood, or synovial fluid
Sterile, leak-proof container • EDTA (lavender-top) tube
Frozen
Tissue and synovial fluid
Room temperature: Unacceptable
Refrigerated: 7 days
Frozen: 30 days

Whole blood and CSF
Room temperature: 48 hours
Refrigerated: 7 days
Frozen: 30 days
Service Area must be determined
Ordering Restrictions may apply. Please provide SERVICE AREA INFORMATION to find available tests you can order.
Please provide SERVICE AREA INFORMATION to confirm Test Code for the lab that services your account.
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.

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