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Test ID: AMPIP Amyloid Protein Identification, Paraffin, LC-MS/MS


Advisory Information


This test should only be ordered on patients in whom a primary diagnosis has already been established. If a patient does not have a primary diagnosis, order PATHC / Pathology Consultation or refer to the Pathology Consultation Ordering Algorithm.

 

If a pathology consultation is desired in addition to this test, order PATHC / Pathology Consultation alone and send the required paperwork with specimen. Indicate that amyloid protein identification is desired. If needed, this test will be added by the reviewing pathologist and will be reported with the consultation. For more information see PATHC / Pathology Consultation.



Shipping Instructions


Attach the green pathology address label included in the kit to the outside of the transport container.



Necessary Information


1. Preliminary pathology report and history are required.

2. A brief explanatory note or consultative letter is also recommended.



Specimen Required


Supplies: Pathology Packaging Kit (T554)

Specimen Type: Formalin-fixed or B5-fixed, paraffin-embedded tissue block

Collection Instructions: Do not send fixed tissue slides. Testing can only be done on paraffin-embedded tissue blocks.


Useful For

Definitive identification of amyloid proteins

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
MLCPC Microdissection, Laser Capture No No
MSPTC Mass Spectrometry No No

Testing Algorithm

In all cases with adequate tissue, an initial Congo red stain is performed before mass spectrometry testing to confirm positivity and pattern of amyloid deposition can be considered when interpreting mass spectrometry results.

 

In some instances, per pathologist discretion, a different initial Congo red stain may be performed using SS2PC / Special Stain, Group II, Other (Bill Only).

-If the stain is negative for amyloid, then this test will not be performed and only the SS2PC will be charged.

-If the stain is positive for amyloid, this test will be performed and the SS2PC billing charge will be credited.

 

A pathology consultation is typically not required. If the amyloid subtyping results do not fit the clinical findings, a PATHC / Pathology Consultation may be added if appropriate, upon client approval.

 

See Laboratory Approach to the Diagnosis of Amyloidosis in Special Instructions.

Method Name

Histological Stain/Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

Reporting Name

Amyloid Protein ID, Par, LC MS/MS

Specimen Type

AMYLOID

Specimen Stability Information

Specimen Type Temperature Time Special Container
AMYLOID Ambient (preferred)
  Refrigerated 

Clinical Information

Amyloidosis is a group of hereditary and acquired diseases that are unified by extracellular tissue deposition of misfolded proteins resulting in end organ damage. Amyloidosis can be a systemic or localized disease. Although many cases of amyloidosis are hereditary, most are acquired as the result of an underlying monoclonal B-cell/plasma cell malignancy, as a phenomenon of aging, or as the result of long-standing chronic inflammation. Specific amyloid-related diseases are therefore associated with specific amyloid proteins. These include kappa or lambda immunoglobulin light chains (AL amyloid), transthyretin (ATTR amyloid), serum amyloid A (SAA amyloid), and other uncommon subtypes. Because treatment of amyloidosis patients differs radically for the different amyloid subtypes, it is critically important to accurately identify the proteins that constitute the amyloid deposits.

 

The basic diagnosis of amyloidosis is typically achieved by Congo red staining of paraffin-embedded tissue biopsy specimens obtained from diverse anatomic sites and demonstrating Congo red-positive, apple-green birefringent, amyloid deposits in the tissues. The next step is to definitively subtype the amyloid deposits. This test fulfills that need. It relies on laser microdissection of Congo red-positive amyloid deposits followed by analysis by liquid chromatography-tandem mass spectrometry to accurately determine the identity of the proteins that constitute the amyloid.

Interpretation

An interpretation will be provided.

Clinical Reference

1. Theis JD, Dasari S, Vrana JA, et al: Shotgun-proteomics-based clinical testing for diagnosis and classification of amyloidosis. J Mass Spectrom. 2013;48(10):1067-1077

2. Said SM, Sethi S, Valeri AM, et al: Renal amyloidosis: origin and clinicopathologic correlations of 474 recent cases. Clin J Am Soc Nephrol. 2013 Sep;8(9):1515-1523

3. Dasari S, Theis JD, Vrana JA, et al. Amyloid typing by mass spectrometry in clinical practice: a comprehensive review of 16,175 samples. Mayo Clin Proc. 2020;95(9):1852-1864. doi:10.1016/j.mayocp.2020.06.029

4. Klein CJ, Vrana JA, Theis JD, et al: Amyloid neuropathy type is distinguished by mass spectrometric based proteomic analysis of nerve tissue. Arch Neurol. 2011:68(2):195-199

5. Vrana JA, Gamez JD, Madden BJ, et al: Classification of amyloidosis by laser microdissection and mass spectrometry-based proteomic analysis in clinical biopsy specimens. Blood. 2009;114(24):4957-4959

Day(s) and Time(s) Performed

Monday through Friday; Varies

Analytic Time

7-15 days

Test Classification

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

CPT Code Information

88313

82542 (if appropriate)

88380 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
AMPIP Amyloid Protein ID, Par, LC MS/MS In Process

 

Result ID Test Result Name Result LOINC Value
71185 Interpretation 50595-8
71186 Participated in the Interpretation No LOINC Needed
71187 Report electronically signed by 19139-5
71189 Material Received 81178-6
71592 Disclaimer 62364-5
72109 Case Number 80398-1

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Cardiovascular Test Request (T724)

-Hematopathology/Cytogenetics Test Request (T726)

-Renal Diagnostics Test Request (T830)