Test Catalog

Test Id : CRGSP

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Cryoglobulin and Cryofibrinogen Panel, Serum and Plasma

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Overview

Test Catalog

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

 

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

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 tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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.

Method Name
A short description of the method used to perform the test

CRY_S, CRY_P: Quantitation and Qualitative Typing Precipitation

IMFXC: Immunofixation

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Cryo Panel, S and P

Aliases
Lists additional common names for a test, as an aid in searching

Cryocrit (suggest cryoglobulin-better test)

Cryofibrinogen

Cryoglobulin Mixed Determination

Cryoglobulin, Plasma and Serum

Cryoprotein

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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.

Specimen Type
Describes the specimen type validated for testing

Plasma EDTA

Serum Red

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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 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 blood 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 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 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.

Forms

If not ordering electronically, complete, print, and send a Benign Hematology Test Request Form (T755) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

Plasma: 0.5 mL

Serum: 3 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

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

 

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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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.

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 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.

 

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. Patients with cryofibrinogenemia often present asymptomatically, but this disorder can also be secondary to numerous conditions that include, but are not limited to, malignancies, infection, inflammation, or thrombotic disorders. Of those with symptoms, primary or essential cryofibrinogenemia can present with systemic manifestations or with a more specific clinical picture that typically includes cold intolerance and thrombotic/hemorrhagic manifestations, such as purpura, necrosis, ulcers and gangrene. 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 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.

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.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

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
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; 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)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

2 to 10 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Negative: 7 days; Positive: until reported

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

82585

82595

86334-Immunofixation (if appropriate)

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
CRGSP Cryo Panel, S and P 74352-6
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
2685 Cryofibrinogen, P 11043-7
2684 Cryoglobulin, S 12201-0

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports