Cryoglobulin Screen with Reflex to Cryoglobulin Panel


Test Code

Quest Code

CPT Codes

If cryoglobulin is present (positive), it is identified. Positives are semi-quantitated (as % cryoglobulin) by cryocrit.
When Cryoglobulin Screen is positive, 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

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-cap 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

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Grossly lipemic • Icteric • Serum separator tube (SST)

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 the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Report Available
5 to 7 Day(s)

Reference Range
Cryoglobulin, QL Negative in normal individuals

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.

Performing Laboratory
Quest Diagnostics Nichols Institute San Juan Capistrano
33608 Ortega Hwy
San Juan Capistrano, CA 92675-2042

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.