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HelpTest ID: CRGSP Cryoglobulin and Cryofibrinogen Panel, Serum and Plasma
Reporting Name
Cryo Panel, S and PUseful For
Evaluating patients with vasculitis, glomerulonephritis, and lymphoproliferative diseases
Evaluating 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.
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 are classified as:
-Type I (monoclonal)
-Type II (mixed--2 or more immunoglobulins of which 1 is monoclonal)
-Type III (polyclonal--in which no monoclonal protein is found)
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's 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.
A cryoprecipitate that is seen in plasma but not in serum is caused by cryofibrinogen. Cryofibrinogens are extremely rare and can be associated with vasculitis. Due to the rarity of clinically significant cryofibrinogenemia, testing for cryoglobulins is usually sufficient for investigation of cryoproteins.
Interpretation
An interpretive report will be provided.
Profile Information
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| CRY_S | Cryoglobulin, S | Yes | Yes |
| CRY_P | Cryofibrinogen, P | No | Yes |
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.
Analytic Time
2 daysDay(s) and Time(s) Performed
Monday through Friday; 4 p.m.
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 Name
CRY_S, CRY_P: Quantitation and Qualitative Typing Precipitation at 1 Degree C
Includes cryofibrinogen.
IMFXC: Immunofixation
Specimen Type
Plasma EDTASerum Red
Specimen Required
Both plasma and serum are required.
Cryofibrinogen
Collection Container/Tube: Lavender top (EDTA)
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
Collection Instructions:
1. Tube must remain at 37° C.
2. 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 plasma from red cells.
3. Place plasma into an appropriately labeled plastic vial.
Cryoglobulin
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 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 draw of a new specimen.
Specimen Minimum Volume
Plasma: 0.5 mL
Serum: 3 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Plasma EDTA | Refrigerated (preferred) | ||
| Frozen | |||
| Serum Red | Refrigerated (preferred) | ||
| Frozen | |||
Reference Values
CRYOGLOBULIN
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.
CRYOFIBRINOGEN
Negative
Quantitation and immunotyping will not be performed on positive cryofibrinogen.
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
82585
82595
86334-Immunofixation (if appropriate)
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| CRGSP | Cryo Panel, S and P | 74352-6 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 2685 | Cryofibrinogen, P | 11043-7 |
| 2684 | Cryoglobulin, S | 12201-0 |
Forms
If not ordering electronically, complete, print, and send a Benign Hematology Test Request Form (T755) with the specimen.
mml-Cerebrovascular, mml-Headache, mml-Demyelinating-Diseases, mml-Neuroimmunology, mml-Neuromuscular, mml-Autonomic, mml-Pediatric, mml-Spinal-Cord