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Cryoglobulin Screen with Reflex to Cryoglobulin Panel
Test Code37358
CPT Codes
82595
Includes
If cryoglobulin is present (positive), it is identified. Positives are semi-quantitated (as % cryoglobulin) by cryocrit.
If Cryoglobulin Screen is positive, then Cryoglobulin Panel (Cryocrit Immunofixation, Cryocrit Immunodiffusion and Rheumatoid Factor) will be performed at an additional charge (CPT Code(s): 86334, 86329, 86431).
If Cryoglobulin Screen is positive, then Cryoglobulin Panel (Cryocrit Immunofixation, Cryocrit Immunodiffusion and Rheumatoid Factor) will be performed at an additional charge (CPT Code(s): 86334, 86329, 86431).
Preferred Specimen
10 mL serum collected in a red-top tube (no gel)
Patient Preparation
Overnight fasting is required
Minimum Volume
3.5 mL
Instructions
Collect 20 mL of fasting whole blood specimen in a red-top tube (no gel). 10 mL serum required; 3.5 mL minimum. Avoid hemolysis.
Allow serum sample to clot for one (1) hour in a 37° C water bath, oven, incubator, or heat block. After clotting, centrifuge the specimen for 10 minutes at 1600 RCF(G) utilizing one of the 3 options below:
1. In a "warm" centrifuge at 37° C
2. In a bench-top centrifuge placed in a "warm room" at 37° C
3. At room temperature, in a bench-top centrifuge prewarmed by running it for 10 minutes at 1600 RCF(G).
After centrifuging, decant serum into a screw-capped vial. Transport at room temperature.
Note: No other tests can be added to the tube; Cryocrit and Cryoglobulin evaluation only.
Allow serum sample to clot for one (1) hour in a 37° C water bath, oven, incubator, or heat block. After clotting, centrifuge the specimen for 10 minutes at 1600 RCF(G) utilizing one of the 3 options below:
1. In a "warm" centrifuge at 37° C
2. In a bench-top centrifuge placed in a "warm room" at 37° C
3. At room temperature, in a bench-top centrifuge prewarmed by running it for 10 minutes at 1600 RCF(G).
After centrifuging, decant serum into a screw-capped vial. Transport at room temperature.
Note: No other tests can be added to the tube; Cryocrit and Cryoglobulin evaluation only.
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 72 hours
Refrigerated: Unacceptable
Frozen: Unacceptable
Refrigerated: Unacceptable
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Grossly lipemic • Icteric • Serum Separator Tube (SST®) • Received refrigerated or frozen
Methodology
Cryocrit • Electrophoresis • Immunodiffusion (ID) • Immunofixation (if needed) • Rate Nephelometry
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Night Sets up 6 days a week.
Report Available
Reports in 5 to 7 days.
Clinical Significance
Cryoglobulins are proteins that precipitate from serum at temperatures below 37° C. Most precipitate when serum is cooled at 4° C, but some gel even at room temperature. The gel or precipitate must redissolve at 37° C to be classified as a cryoglobulin.
