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EPIC ORDER CODE LAB1887 Cryoglobulin, Serum

Additional Codes

MAYO: CRY_S

Sunquest: CRYSM

Reporting Name

Cryoglobulin, S

Useful For

Evaluating cryoglobulins in patients with vasculitis, glomerulonephritis, and lymphoproliferative diseases

 

Evaluating cryoglobulins in patients with macroglobulinemia or myeloma in whom symptoms occur with cold exposure

 

This test is not useful for general screening of a population without a clinical suspicion of cryoglobulinemia.

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
IMFXC Immunofixation Cryoglobulin No No

Testing Algorithm

If cryoglobulin has a positive result after 1 or 7 days, then immunofixation will be performed at an additional charge. Positive cryoglobulins of 0.1 mL or above of precipitate will be typed once.

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum Red


Ordering Guidance


This test is also available as a part of a profile to assess for both cryofibrinogen and cryoglobulin. For more information see CRGSP / Cryoglobulin and Cryofibrinogen Panel, Serum and Plasma.



Specimen Required


Collection Container/Tube: Red top (serum gel/SST are not acceptable)

Submission Container/Tube: Plastic vial

Specimen Volume: 5 mL

Collection Instructions:

1. Tube must remain at 37° C.

2. Allow blood to clot at 37° C.

3. Centrifuge at 37° C. Do not use a refrigerated centrifuge. If absolutely necessary, ambient temperature is acceptable. It is very important that the specimen remain at 37° C until after separation of serum from red blood cells.

4. Place serum into an appropriately labeled plastic vial.

Additional Information: Analysis cannot be performed with less than 3 mL of serum. Smaller volumes are insufficient to detect clinically important trace (mixed) cryoglobulins. Less than 3 mL will require collection and submission a new specimen.


Specimen Minimum Volume

3 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Red Refrigerated (preferred)
  Frozen 

Reference Values

Negative (positives reported as percent or trace amount) 

If positive after 1 or 7 days, immunotyping of the cryoprecipitate is performed at an additional charge.

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

82595

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CRY_S Cryoglobulin, S 12201-0

 

Result ID Test Result Name Result LOINC Value
2684 Cryoglobulin, S 12201-0

Clinical Information

Cryoglobulins are immunoglobulins that precipitate when cooled and dissolve when heated. Because these proteins precipitate when cooled, patients may experience symptoms when exposed to the cold. Cryoglobulins may be associated with a variety of diseases including plasma cell disorders, autoimmune diseases, and infections. Cryoglobulins may also cause erroneous results with some automated hematology instruments.

 

Cryoglobulins may be classified as follows: Type I, Type II, and Type III. Type I is composed of a monoclonal immunoglobulin: IgG or IgM, or rarely IgA or free monoclonal light chains. Type II cryoglobulins consist of a monoclonal component and a polyclonal component. Finally, type III cryoglobulins are composed of only polyclonal immunoglobulins.

 

The majority of patients with cryoglobulins are asymptomatic. The type or quantity of cryoglobulin does not reliably predict whether or which symptoms will be present. The concentration of cryoglobulins tends to vary by type with the majority of cases: of type III, being less than 1 mg/mL; of type II, greater than 1 mg/mL; and of type I, greater than 5 mg/mL. Even though the type I cryoglobulin concentrations tend to be the highest, they are the least likely to cause symptoms. The thermal amplitude (temperature at which the cryoglobulin precipitates) is a better predictor of symptoms than quantity or type.

 

Symptoms of cryoglobulinemia include purpura, Raynaud phenomenon, cyanosis, skin ulceration, gangrene, kidney failure, peripheral neuropathy, fever, and malaise.

 

Type I cryoglobulinemia is associated with monoclonal gammopathy of undetermined significance, macroglobulinemia, or multiple myeloma.

 

Type II cryoglobulinemia is associated with autoimmune disorders such as vasculitis, glomerulonephritis, systemic lupus erythematosus, rheumatoid arthritis, and Sjogren syndrome. It may be seen in infections such as hepatitis, infectious mononucleosis, cytomegalovirus, and toxoplasmosis. Type II cryoglobulinemia may also be essential, ie, occurring in the absence of underlying disease.

 

Type III cryoglobulinemia usually demonstrates trace levels of cryoprecipitate, may take up to 7 days to appear, and is associated with the same disease spectrum as Type II cryoglobulinemia.

Interpretation

An interpretive report will be provided

Clinical Reference

1. Kyle RA, Lust JA: Immunoglobulins and laboratory recognition of monoclonal proteins. Section III. Myeloma and related disorders. In: Wiernik PH, Canellos GP, Dutcher JP, Kyle RA, eds. Neoplastic Diseases of the Blood. 3rd ed. Churchill Livingstone; 1996:453-475

2. Desbois AC, Cacoub P, Saadoun D: Cryoglobulinemia: An update in 2019. Joint Bone Spine. 2019 Nov;86(6):707-713. doi: 10.1016/j.jbspin.2019.01.016

Method Description

The normal proteins of serum do not precipitate in the cold. An aliquot of serum is incubated for 24 hours at 1 degree C. If a precipitate develops in the serum, the specimen is centrifuged, and the percent precipitate is reported. Negative specimens are kept at 1 degree C for 7 days and rechecked. All positive cryoglobulins are analyzed by immunofixation to determine if the precipitate is a monoclonal protein, polyclonal protein, or a mixed cryoglobulin.(Lerner AB, Watson CJ: Studies of cryoglobulins; unusual purpura associated with the presence of a high concentration of cryoglobulin [cold precipitable serum globulin]. Am J Med Sci. 1947 Oct;214[4]:410-415; Desbois AC, Cacoub P, Saadoun D: Cryoglobulinemia: An update in 2019. Joint Bone Spine. 2019 Nov;86(6):707-713. doi: 10.1016/j.jbspin.2019.01.016)

Report Available

2 to 10 days

Specimen Retention Time

2 weeks

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Method Name

CRY_S: Quantitation and Qualitative Typing Precipitation
IMFXC: Immunofixation

Forms

If not ordering electronically, complete, print, and send a Renal Diagnostics Test Request (T830) with the specimen.