NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Evaluating patients with vasculitis, glomerulonephritis, and lymphoproliferative diseases
Evaluating patients with macroglobulinemia or myeloma in whom symptoms occur with cold exposure
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|
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 iImmunofixation will be performed at an additional charge. Positive cryoglobulins of > or =0.1 mL of precipitate will be typed once.
CRY_S/80988: Quantitation and Qualitative Typing Precipitation at 1 Degree C.
Orderable as part of a panel or as a stand alone test. For further information see CRGSP/83659 Cryoglobulin and Cryofibrinogen Panel, Serum and Plasma.
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Specimen Type Describes the specimen type needed for testing
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.
Collection Container/Tube: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 5 mL
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.
Mild OK; Gross OK
Mild OK; Gross OK
Mild OK; Gross OK
Serum gel tube; 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.
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.
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.
Negative (positives reported as percent)
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. 3rd 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 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. 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 pm
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
Negative (Positive reported as percent) If Positive after 1 or 7 days, immunotyping of the cryoprecipitate is performed at an additional charge.
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test uses a standard method. Its performance characteristics were determined 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
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|
|2684||Cryoglobulin, S||In Process|