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Test Code IGGS4 IgG4, Immunoglobulin Subclasses, Serum

Reporting Name

IgG4, Ig Subclasses

Useful For

Supporting the diagnosis of IgG4-related disease

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

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


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

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: ≤49.1 mg/dL

4-<7 years: ≤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: ≤121.7 mg/dL

16-<18 years: ≤111.0 mg/dL

≥18 years: 2.4-121.0 mg/dL

Day(s) Performed

Monday through Friday

Test Classification

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

82787

LOINC Code Information

Test ID Test Order Name Order LOINC Value
IGGS4 IgG4, Ig Subclasses 2469-5

 

Result ID Test Result Name Result LOINC Value
IGGS4 IgG4, Ig Subclasses 2469-5

Clinical Information

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.

Interpretation

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

Cautions

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.

Report Available

1 to 2 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus OK

Method Name

Turbidimetry