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Test Code IGS4 Immunoglobulin Subclass IgG4, Serum

Reporting Name

Immunoglobulin Subclass IgG4, S

Useful For

Supporting the diagnosis of IgG4-related disease

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum


Advisory Information


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



Specimen Required


Patient Preparation: Fasting preferred but not required

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 1 mL


Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 14 days
  Ambient  14 days
  Frozen  14 days

Reference Values

0-<5 months: ≤19.8 mg/dL

5-<9 months: ≤20.8 mg/dL

9-<15 months: ≤22.0 mg/dL

15-<24 months: ≤23.0 mg/dL

2-<4 years: 0.4-49.1 mg/dL

4-<7 years: 0.8-81.9 mg/dL

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

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

13-<16 years: 0.7-121.7 mg/dL

16-<18 years: 0.3-111.0 mg/dL

≥18 years: 2.4-121.0 mg/dL

Day(s) and Time(s) Performed

Monday through Friday; Continuously

Test Classification

This test has been cleared, approved or is exempt by the U.S. 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

82787

LOINC Code Information

Test ID Test Order Name Order LOINC Value
IGGS4 Immunoglobulin Subclass IgG4, S 2469-5

 

Result ID Test Result Name Result LOINC Value
IGGS4 Immunoglobulin Subclass IgG4, S 2469-5

Clinical Reference

1. Cheuk W, Chan JK: 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

Method Description

In this Siemens Nephelometer II method, the light scattered onto the antigen-antibody complexes is measured. The intensity of the measured scattered light is proportional to the amount of antigen-antibody complexes in the sample under certain conditions. If the antibody volume is kept constant, the signal behaves proportionally to the antigen volume.

 

A reference curve is generated by a standard with a known antigen content on which the scattered light signals of the samples can be evaluated and calculated as an antigen concentration. Antigen-antibody complexes are formed when a sample containing antigen and the corresponding antiserum are put into a cuvette. A light beam is generated with an LED, which is transmitted through the cuvette. The light is scattered onto the immuno-complexes that are present. Antigen and antibody are mixed in the initial measurement, but no complex is formed yet. An antigen-antibody complex is formed in the final measurement.

 

The result is calculated by subtracting value of the final measurement from the initial measurement. The distribution of intensity of the scattered light depends on the ratio of the particle size of the antigen-antibody complexes to the radiated wavelength.(Unpublished Mayo method; Instruction manual: Siemens Nephelometer II, Version 3, Siemens, Inc., Newark, DE, 2008)

Analytic Time

Same day/1 day

Reject Due To

Gross hemolysis OK
Gross lipemia Reject
Gross icterus OK

Method Name

Nephelometry

Secondary ID

84250