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Test Id : CRY_S
Cryoglobulin, Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
Suggests clinical disorders or settings where the test may be helpful
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
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial 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.
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
A short description of the method used to perform the test
CRY_S: 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.
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
Lists a shorter or abbreviated version of the Published Name for a test
Cryoglobulin, S
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
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
Describes the specimen type validated for testing
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
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
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 Renal Diagnostics Test Request (T830) with the specimen.
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory
3 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
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
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 |
|---|---|---|---|
| Serum Red | Refrigerated (preferred) | ||
| Frozen | |||
Useful For
Suggests clinical disorders or settings where the test may be helpful
Suggests clinical disorders or settings where the test may be helpful
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.
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
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
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.
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.
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.
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.
Interpretation
Provides information to assist in interpretation of the test results
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
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
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
Describes how the test is performed and provides a method-specific reference
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)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
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.
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.
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
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
2 weeks
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
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.
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 Regional Manager. 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.
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.
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.
CPT codes are provided by the performing laboratory.
82595
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.
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 |
|---|---|---|
| CRY_S | Cryoglobulin, S | 12201-0 |
| 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.
|
|---|---|---|
| 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.
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.
Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.
Normal and Abnormal sample reports are provided as references for report appearance.
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.
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.