Test Catalog

Test Id : IGGS4

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IgG4, Immunoglobulin Subclasses, Serum

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Overview

Test Catalog

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

Supporting the diagnosis of IgG4-related disease

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

Turbidimetry

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

IgG4, Ig Subclasses

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

This test only quantitates the IgG4 protein. If quantitation of all IgG subclass types is desired, order IGGS / IgG Subclasses, Serum.

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

Patient Preparation: Fasting preferred but not required

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.5 mL

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

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus OK

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
Serum Refrigerated (preferred) 14 days
Ambient 14 days
Frozen 14 days

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

Supporting the diagnosis of IgG4-related disease

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

The most abundant immunoglobulin isotype in human serum is IgG. IgG immunoglobulins are comprised of 4 subclasses, designated IgG1 through IgG4. Of total IgG, approximately 65% is IgG1, 25% is IgG2, 6% is IgG3, and 4% is IgG4. Each IgG subclass contains structurally unique portions of the constant region of the gamma heavy chain.

 

IgG subclass 4-related disease is a  systemic inflammatory disease of unknown etiology, most often occurring in middle-aged and older men. Several organ systems can be involved, and the disease encompasses many previous and newly described diseases such as autoimmune pancreatitis; Mikulicz disease and sclerosing sialadenitis; inflammatory orbital pseudotumor; chronic sclerosing aortitis; Riedel thyroiditis, a subset of Hashimoto thyroiditis; IgG4-related interstitial pneumonitis; and IgG4-related tubulointerstitial nephritis. These entities may be characterized by tumor-like swelling of the involved organs with infiltration by numerous IgG4-positive plasma cells with accompanying fibrosis. In addition, elevated serum concentrations of IgG4 are found in at least 50% of patients diagnosed with IgG4-related disease.

 

The diagnosis of IgG4-related disease may require a tissue biopsy of the affected organ demonstrating the aforementioned histological features. It is recommended that patients suspected of having an IgG4-related disease have their serum IgG4 measured.

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.

0-<5 months: < or =19.8 mg/dL

5-<9 months: < or =20.8 mg/dL

9-<15 months: < or =22.0 mg/dL

15-<24 months: < or =23.0 mg/dL

2-<4 years: < or =49.1 mg/dL

4-<7 years: < or =81.9 mg/dL

7-<10 years: 1.0-108.7 mg/dL

10-<13 years: 1.0-121.9 mg/dL

13-<16 years: < or =121.7 mg/dL

16-<18 years: < or =111.0 mg/dL

> or =18 years: 2.4-121.0 mg/dL

Interpretation
Provides information to assist in interpretation of the test results

Elevated concentration of IgG4 is consistent with, but not diagnostic of, IgG4-related disease.

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

Elevations in serum IgG4 concentrations are not specific to IgG4-related disease; they are also found in disorders such as multicentric Castleman disease, allergic disorders, Churg-Strauss syndrome, sarcoidosis, and other conditions.

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

1. Cheuk W, Chan JKC. IgG4-related sclerosing disease: a critical appraisal of an evolving clinicopathologic entity. Adv Anat Pathol. 2010;17(5):303-332

2. Zen Y, Nakanuma Y. IgG4-related disease: a cross-sectional study of 114 cases. Am J Surg Pathol. 2010;34(12):1812-1819

3. Bateman AC, Deheragoda MG. IgG4-related systemic sclerosing disease-an emerging and under-diagnosed condition. Histopathology. 2009;55(4):373-383

4. Vidarsson G, Dekkers G, Rispens T. IgG subclasses and allotypes: from structure to effector functions. Front Immunol. 2014;5:520

5. Maslinska M, Dmowska-Chalaba J, Jakubaszek M. The role of IgG4 in autoimmunity and rheumatic diseases. Front Immunol. 2022;12:787422

6. Wallace ZS, Naden RP, Chari S, et al. The 2019 American College of Rheumatology/European League Against Rheumatism classification criteria for IgG4-related disease. Ann Rheum Dis. 2020;79(1):77-87. doi:10.1136/annrheumdis-2019-216561

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

The determination of the soluble antigen concentration by turbidimetric methods involves the reaction with specific antiserum to form insoluble complexes. When light is passed through the suspension formed a portion of the light is transmitted and focused onto a photodiode by an optical lens system. The amount of transmitted light is indirectly proportional to the specific protein concentration in the test sample.

 

Concentrations are automatically calculated by reference to a calibrations curve stored within the instrument.(Package inserts: Optilite IgG4. The Binding Site Group, Ltd: ver.23, 07/2019)

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

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

14 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 has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

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.

82787

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
IGGS4 IgG4, Ig Subclasses 2469-5
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.
IGGS4 IgG4, Ig Subclasses 2469-5

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
Test Changes - Title 2023-07-27
Test Changes - Method 2023-04-04