Test Catalog

Test Id : TWRP

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Tropheryma whipplei, Molecular Detection, PCR, Varies

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aiding in the diagnosis of Whipple disease, especially for identifying inconclusive or suspicious cases, using tissue or fluid specimens

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Method Name
A short description of the method used to perform the test

Real-Time Polymerase Chain Reaction (PCR)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Tropheryma whipplei PCR

Aliases
Lists additional common names for a test, as an aid in searching

Whipple's Disease

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Specimen Type
Describes the specimen type validated for testing

Varies

Necessary Information

Specimen source is required.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
SRC56 Specimen Source

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

The high sensitivity of amplification by polymerase chain reaction requires the specimen to be processed in an environment in which contamination of the specimen by Tropheryma whipplei DNA is unlikely.

 

Submit only 1 of the following specimens:

 

Specimen Type: Fresh tissue or biopsy

Sources: Small intestine (duodenum, ileum, or jejunum), lymph node, bone, joint, synovial, liver, pancreas, spleen, lung, heart valve (and other heart tissues), or brain

Container/Tube: Sterile container

Specimen Volume: Entire collection or 5 mm(3) - approximately the size of a pencil eraser

Collection Instructions:

1. Collect fresh tissue specimen.

2. Submit tissue only, do not add fluid to tissue.

3. Refrigerate or freeze specimen.

Specimen Stability Information: Refrigerated (preferred) <7 days /Frozen <7 days

 

Preferred Paraffin-embedded tissue block:

Supplies: Tissue Block Container (T553)

Specimen Type: Formalin-fixed, paraffin-embedded tissue block (FFPE)

Sources: Small intestine (duodenum, ileum, or jejunum), lymph node, bone, joint, synovial, liver, pancreas, spleen, lung, heart valve (and other heart tissues), or brain

Container/Tube: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block to be cut and returned.

Specimen Stability Information: Ambient (preferred)/Refrigerated

 

Acceptable Paraffin-embedded tissue block:

Specimen Type: Formalin-fixed, paraffin-embedded tissue block (FFPE)

Sources: Small intestine (duodenum, ileum, or jejunum), lymph node, bone, joint, synovial, liver, pancreas, spleen, lung, heart valve (and other heart tissues), or brain

Container/Tube: Sterile container for each individual cut section (scroll).

Collection Instructions: Perform microtomy and prepare five separate 10-micron sections. Each section (scroll) must be placed in a separate sterile container for submission.

Specimen Stability Information: Ambient (preferred)/Refrigerated

 

Specimen Type: Fluid

Sources: Cerebrospinal or ocular (eg, vitreous humor)

Container/Tube: Sterile vial

Specimen Volume: 0.5 mL

Specimen Stability Information: Refrigerated (preferred) <7 days/Frozen <7 days

 

Specimen Type: Synovial fluid

Container/Tube:

Preferred: Lavender top (EDTA)

Acceptable: Pink top (EDTA), royal blue top (EDTA), sterile vial containing EDTA-derived aliquot, red clot tube (no anticoagulant), or sterile container

Specimen Volume: 0.5 mL

Collection Instructions: Send specimen in original tube (preferred).

Specimen Stability Information: Refrigerated (preferred) <7 days /Frozen <7 days

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

If not ordering electronically, complete, print, and send a  Gastroenterology and Hepatology Test Request (T728) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

Fluid: 0.5 mL

Fresh tissue or biopsy: 5 mm(3)

Paraffin-embedded tissue block: two 10-micron sections

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Slides
Bone marrow 		Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Varies Varies

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aiding in the diagnosis of Whipple disease, especially for identifying inconclusive or suspicious cases, using tissue or fluid specimens

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Whipple disease is a chronic, systemic illness that, in most cases, involves the small intestine and its lymphatic drainage. The disease primarily affects adults of middle age, with a peak incidence in the third and fourth decades. Clinical findings may include malabsorption, chronic diarrhea, abdominal pain, arthralgia, fever, and central nervous system symptoms.

 

Pathologic changes associated with Whipple disease are distinctive, with diagnosis dependent on histologic examination of biopsy specimens from involved tissues. Electron microscopic or special high-resolution light microscopic examination of the lamina propria of the small intestine of patients with untreated Whipple disease reveals many rod-shaped bacillary organisms. These tiny bacilli, referred to as Whipple bacilli, measure about 0.25 micrometer long and are seen as periodic acid-Schiff-positive granules within macrophages. These inclusions represent fragments of the cell walls from degenerating bacilli.

 

Culture of Whipple bacilli from biopsy material is laborious and the organism is very slow growing. Definitive identification of the Whipple associated bacillus has been difficult because of these limitations. Molecular techniques using polymerase chain reaction and nucleotide sequencing allowed classification of this bacillus as an actinomycete not closely related to any other known species, which has been named Tropheryma whipplei.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Not applicable

Interpretation
Provides information to assist in interpretation of the test results

A positive result indicates the presence of Tropheryma whipplei DNA.

 

A negative result indicates the absence of detectable T whipplei DNA but does not negate the presence of the organism and may occur due to inhibition of polymerase chain reaction, sequence variability underlying primers or probes, or the presence of T whipplei DNA in quantities less than the limit of detection of the assay.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Test results should be used as an aid in diagnosis and not be considered diagnostic in themselves. The single assay should not be used as the only criteria to form a clinical conclusion, but results should be correlated with patient symptoms and clinical presentation. A negative result does not negate the presence of the organism or active disease.

Supportive Data

A total of 321 clinical specimens (including blood, tissue, cerebrospinal fluid, and synovial fluid) were evaluated for the presence of Tropheryma whipplei DNA by targeting the heat shock protein 65 gene using the LightCycler Whip assay and results were compared to those of a conventional polymerase chain reaction (PCR) assay. The sensitivity and specificity of the LightCycler Whip compared to conventional PCR were 98% and 99%, respectively. The analytical sensitivity was less than 50 targets per reaction. The LightCycler Whip showed no cross reaction when tested on a panel of 28 organisms genotypically closely related to T whipplei by BLAST analysis.

Method Description
Describes how the test is performed and provides a method-specific reference

Nucleic acid is extracted from all specimens using the MagNA Pure extraction system. The resulting nucleic acid is tested for the presence of the target DNA of Tropheryma whipplei using the LightCycler real-time polymerase chain reaction (PCR). The instrument amplifies and continuously monitors the development of target nucleic acid using fluorescent resonance emission technology after each cycle. Analysis of the PCR amplification and probe melting curves is accomplished through the use of the LightCycler software.(Sloan LM, Rosenblatt JE, Cockerill FR III: Detection of Tropheryma whipplei DNA in clinical specimens by LightCycler real-time PCR. J Clin Microbiol. 2005 Jul;43(7):3516-3518; Geibdorfer W, Moter A, Bogdan C: Tropheryma whipplei. In: Carroll K, Pfaller M, eds. Manual of Clinical Microbiology. 12th ed. ASM Press; 2019:1189-1197)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

2 to 7 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

1 week

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87798

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
TWRP Tropheryma whipplei PCR 97206-7
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
SRC56 Specimen source 31208-2
22302 Tropheryma whipplei PCR, Result 97206-7

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | PHP Pdf | CMS Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports