Test Catalog

Test Id : HIGM

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Heavy-Light Chain IgM Kappa/IgM Lambda, Immunofluorescence

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Overview

Test Catalog

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

Immunofluorescent staining of IgM kappa and IgM lambda to aid in the diagnosis of monoclonal gammopathy-associated nephropathies

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
IFPCI IF Initial No No
IFPCA IF Additional No No

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

For the initial immunofluorescence (IF) stain performed, the appropriate bill-only test ID will be added and charged (IFPCI). For each additional IF stain performed, an additional bill-only test ID will be added and charged (IFPCA).

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

Direct Immunofluorescence

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

HLC IgM Kappa Lambda IF

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

Heavy chain/light chain

Monoclonal gammopathy-associated lesions

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

For the initial immunofluorescence (IF) stain performed, the appropriate bill-only test ID will be added and charged (IFPCI). For each additional IF stain performed, an additional bill-only test ID will be added and charged (IFPCA).

Specimen Type
Describes the specimen type validated for testing

Special

Ordering Guidance

If additional interpretation/analysis is needed, request PATHC / Pathology Consultation along with this test and send the corresponding renal pathology light microscopy and immunofluorescence (IF) slides (or IF images on a CD), electron microscopy images (prints or CD), and the pathology report.

Shipping Instructions

1. Advise shipping specimens in Styrofoam transportation coolers to avoid extreme hot or cold temperatures to ensure specimens are received at required specimen stability temperature.

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

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

Preferred: Frozen tissue

Supplies: Renal Biopsy Kit (T231)

Specimen Type: Kidney tissue

Container/Tube: Renal Biopsy Kit, Zeus/Michel's

Specimen Volume: Entire specimen

Collection Instructions: Collect specimens according to the instructions in Renal Biopsy Procedure for Handling Tissue for Light Microscopy (LM), Immunofluorescent Histology (IF), and Electron Microscopy (EM) in Special Instructions.

Additional Information: If standard immunoglobulin and complement immunofluorescence has already been performed, submit the residual frozen tissue (must contain glomeruli) on dry ice.

 

Acceptable: Tissue slides

Collection Instructions: Submit 2 frozen tissue unstained positively charged glass slides (25- x 75- x 1-mm) per test ordered; sections 4-microns thick. Ship on dry ice.

Forms

Renal Biopsy Patient Information in Special Instructions

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

  All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

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
Special Frozen (preferred)
Ambient
Refrigerated

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

Immunofluorescent staining of IgM kappa and IgM lambda to aid in the diagnosis of monoclonal gammopathy-associated nephropathies

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

For the initial immunofluorescence (IF) stain performed, the appropriate bill-only test ID will be added and charged (IFPCI). For each additional IF stain performed, an additional bill-only test ID will be added and charged (IFPCA).

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

Heavy chain/light chain (HLC) antibodies target conformational epitopes at the junctions of the heavy chain and light chain constant regions (CH1 and CL) of serum IgA kappa, IgA lambda, IgG kappa, IgG lambda, IgM kappa, and IgM lambda to provide quantitation of intact HLC pairs and aid in determining monoclonality. Direct HLC tissue immunofluorescence demonstrates that HLC antibodies complement conventional immunofluorescence in the pathologic diagnosis of monoclonal gammopathy-associated kidney lesions (eg, heavy chain deposition disease and proliferative glomerulonephritis with monoclonal immunoglobulin deposits), can unmask polytypic IgM deposits, and assist in the pathologic distinction between type II and III cryoglobulinemic glomerulonephritis.

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

Staining intensity is graded as negative (0), weak (trace, 1+), moderate (2+) and strong (3+).

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

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

1. Leung N, Bridoux F, Batuman V, et al: The evaluation of monoclonal gammopathy of renal significance: a consensus report of the International Kidney and Monoclonal Gammopathy Research Group. Nat Rev Nephrol. 2019 Jan;15(1):45-59

2. Bridoux F, Leung N, Hutchison CA, et al: International Kidney and Monoclonal Gammopathy Research Group. Diagnosis of monoclonal gammopathy of renal significance. Kidney Int. 2015 ;87(4):698-711

3. Gagliardi A, Carbone C, Russo A, et al: Combined use of free light chain and heavy/light chain ratios allow diagnoses and monitoring of patients with monoclonal gammopathies: Experience of a single institute, with three exemplar case reports. Oncol Lett. 2016;12:2363-2370. doi: 10.3892/ol.2016.4965

4. Koulieris E, Panayiotidis P, Harding S, et al: Ratio of involved/uninvolved immunoglobulin quantification by Hevylite assay: Clinical and prognostic impact in multiple myeloma. Exper Hematol Oncol. 2012;1:9. doi: 10.1186/2162-3619-1-9

5. Joly F, Cohen C, Javaugue V, et al: Randall-type monoclonal immunoglobulin deposition disease: novel insights from a nationwide cohort study. Blood. 2019;133(6):576-587

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

Direct immunofluorescence staining on sections of frozen renal tissue.(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.

1 to 2 days

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. This test 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.

88346-Primary IF

88350-If add'l IF

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
HIGM HLC IgM Kappa Lambda IF In Process
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.
610398 Interpretation 50595-8
610399 Participated in the Interpretation No LOINC Needed
610400 Report electronically signed by 19139-5
610401 Addendum 35265-8
610403 Material Received 94736-6
610402 Gross Description 22634-0
610404 Disclaimer 62364-5
610405 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

Test Update Resources

Change Type Effective Date
New Test 2021-09-07