Test Catalog

Test Id : AMPIP

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Amyloid Protein Identification, Paraffin, Mass Spectrometry

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Overview

Test Catalog

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

Definitive identification of amyloid proteins

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
MLCPC Microdissection, Laser Capture No, (Bill Only) No
MSPTC Mass Spectrometry No, (Bill Only) No

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

Testing begins with a Congo red stain. If the Congo red stain is positive, testing proceeds with microdissection at an additional charge to obtain tissue of interest and subsequently perform mass spectrometry at an additional charge to identify protein involved.

 

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, PATHC / Pathology Consultation may be added if appropriate, upon client approval.

 

For more information see Amyloidosis: Laboratory Approach to Diagnosis.

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

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

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

Amyloid Protein ID, Par, LC MS/MS

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

GPAMYPROPAR

GPMSCBB

Amyloid AA

Amyloid AL

Amyloid ATTR

Amyloid LECT-2

Amyloid

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

Testing begins with a Congo red stain. If the Congo red stain is positive, testing proceeds with microdissection at an additional charge to obtain tissue of interest and subsequently perform mass spectrometry at an additional charge to identify protein involved.

 

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, PATHC / Pathology Consultation may be added if appropriate, upon client approval.

 

For more information see Amyloidosis: Laboratory Approach to Diagnosis.

Specimen Type
Describes the specimen type validated for testing

AMYLOID

Ordering Guidance

This test should only be ordered on patients for 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. Include performed Congo red slide

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

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

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

Collection Instructions:

1. Do not send fixed tissue slides for testing. Testing can only be done on paraffin-embedded tissue blocks.

2. If Congo red stain has already been performed, send Congo red stained slide along with the tissue block.

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

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)

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

Fixed tissue slides
Wet/frozen tissue
Cytological smears
Nonformalin fixed tissue
Nonparaffin embedded tissue 		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
AMYLOID Ambient (preferred)
Refrigerated

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

Definitive identification of amyloid proteins

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

Testing begins with a Congo red stain. If the Congo red stain is positive, testing proceeds with microdissection at an additional charge to obtain tissue of interest and subsequently perform mass spectrometry at an additional charge to identify protein involved.

 

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, PATHC / Pathology Consultation may be added if appropriate, upon client approval.

 

For more information see Amyloidosis: Laboratory Approach to Diagnosis.

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

Amyloidosis is a group of hereditary and acquired diseases 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 patients with amyloidosis 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.

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.

An interpretive report will be provided.

Interpretation
Provides information to assist in interpretation of the test results

An interpretation will be provided.

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

In rare instances amyloid deposits may show a false-negative result by Congo red staining. Because this test depends on the presence of Congo red-positive amyloid, these cases may not be identified as amyloid by this testing algorithm. Correlation with clinical and pathologic features and other laboratory test results is recommended to definitively exclude a diagnosis of amyloidosis.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Theis JD, Dasari S, Vrana JA, Kurtin PJ, Dogan A. 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;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. Mass spectrometric-based proteomic analysis of amyloid neuropathy type in nerve tissue. Arch Neurol. 2011;68(2):195-199

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

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

Affected areas are removed from paraffin-embedded tissues by laser microdissection. Protein digestion is performed, followed by liquid chromatography tandem mass spectrometry.(Unpublished Mayo method)

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.

7 to 15 days

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

Submitted block: Not retained; Congo red-stained slides performed at Mayo Clinic: Indefinitely

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.

88313

82542 (if appropriate)

88380 (if appropriate)

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
AMPIP Amyloid Protein ID, Par, LC MS/MS 101405-9
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.
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

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 | 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