Test ID: CRGSP
Cryoglobulin and Cryofibrinogen Panel, Serum and Plasma
NY State Approved 
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Evaluating patients with vasculitis, glomerulonephritis, and lymphoproliferative diseases
Evaluating patients with macroglobulinemia or myeloma in whom symptoms occur with cold exposure
Profile Information A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| CRY_S | Cryoglobulin, S | Yes | Yes |
| CRY_P | Cryofibrinogen, P | No | Yes |
Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| IMFXC | Immunofixation Cryoglobulin | No | No |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
If cryoglobulin has a result other than negative, then immunofixation will be performed at an additional charge. Positive cryoglobulins of > or =0.1 mL of precipitate will be typed once.
Method Name A short description of the method used to perform the test
CRY_S/80988, CRY_P/80550: Quantitation and Qualitative Typing Precipitation at 1 Degree C
Includes cryofibrinogen.
IMFXC/28265: Immunofixation
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Cryofibrinogen
Cryoglobulin Mixed Determination
Cryoglobulin, Plasma and Serum
Cryoprotein
Specimen Type Describes the specimen type needed for testing
Serum
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Forms: If not ordering electronically, submit a General Request Form (Supply T239) with the specimen.
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 degrees C.
2. Centrifuge at 37 degrees C. (Do not use a refrigerated centrifuge. If absolutely necessary, ambient temperature is acceptable.) It is very important that the specimen remain at 37 degrees C until after separation of plasma from red cells.
3. Place plasma into an appropriately labeled plastic vial.
Cryoglobulin
Collection Container/Tube: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 5 mL
Collection Instructions:
1. Tube must remain at 37 degrees C.
2. Allow blood to clot at 37 degrees C.
3. Centrifuge at 37 degrees C. (Do not use a refrigerated centrifuge. If absolutely necessary, ambient temperature is acceptable.) It is very important that the specimen remain at 37 degrees 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 <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 Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross OK |
| Lipemia | Mild OK; Gross OK |
| Icterus | Mild OK; Gross OK |
| Other | Serum gel tube or plasma gel tube |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Plasma EDTA | Refrigerated (preferred) | |
| Frozen | ||
| Serum | Refrigerated (preferred) | |
| Frozen | ||
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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.
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.
CRYOGLOBULIN
Negative (positives reported as percent)
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.
Interpretation Provides information to assist in interpretation of the test results
An interpretive report will be provided.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Failure to follow specimen handling instructions may cause false-negative results.
Not useful for general screening of a population without a clinical suspicion of cryoglobulinemia.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
Kyle RA, Lust JA: Immunoglobulins and laboratory recognition of monoclonal proteins. Section III. Myeloma and related disorders. In Neoplastic Diseases of the Blood. Third edition. Edited by PH Wiernik, GP Canellos, JP Dutcher, RA Kyle. New York, Churchill Livingstone, 1996, pp 453-475
Method Description Describes how the test is performed and provides a method-specific reference
The normal proteins of plasma and serum do not precipitate in the cold. An aliquot of plasma and of serum are 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. Precipitates that occur in plasma and not serum are reported as positive for cryofibrinogen. Cryofibrinogen-positive specimens are not quantitated or immunotyped. Slowly forming fibrin clots (as may occur in hemophilia) are distinguished from cryoprecipitates by their inability to redissolve on warming.(Lerner AB, Watson CJ: Studies of cryoglobulins. I. Unusual purpura associated with the presence of a high concentration of cryoglobulin [cold precipitatable serum globulin]. Am J Med Sci 1947;214:410-415)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 4 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
82585-Cryofibrinogen
82595-Cryoglobulin
86334-Immunofixation (if appropriate)
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| 2685 | Cryofibrinogen, P | 11043-7 |
| 2684 | Cryoglobulin, S | In Process |
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