Cryoglobulin, Qualitative With Quantitative Reflex

Last Modified: 8/17/2023 8:27:36 AM


Medical Necessity Documentation:  
Client Notes:  
Patient Preparation: Patient must be fasting
Specimen Requirements: 3.0 mL Serum prewarmed, from a Red Top Tube in a Plastic Vial
Collection Instructions: Specimen must be drawn in a prewarmed tube and kept at 37°C while clotting.  
After specimen is collected, maintain 37°C  by wrapping a heel warmer around tube or placing tube in a heat block until clotted.

After clot formation, separate serum from cells immediately.

Transfer serum into a clean transport tube and label transport tube "Prewarmed."
Minimum Volume: 2.0 mL Serum, prewarmed
Transport & Storage: Temperature/Stability:  
Rejection Criteria: Specimen not allowed to clot at 37°C; patient not fasting; lipemia; gel-barrier tube used for collection; whole blood received
Reference Range: None detected (positives are reported as percentages)
Critical Ranges:  
Test Comments:  
Methodology: Visual observation of refrigerated samples
Clinical Significance: Cryoglobulins may be present in macroglobulinemia of Waldenström, myeloma, chronic lymphocytic leukemia, lupus, chronic active hepatitis, and other viral infections.
Documentation: These are proteins that precipitate from blood at low temperatures. A precipitate from serum that forms overnight at 4°C and dissolves at 37°C is called a cryoglobulin.

Cryoglobulins may be divided into three classes. Type I are monoclonal immunoglobulins and are usually associated with lymphoproliferative disorders. Type II are mixtures of a monoclonal IgM and polyclonal IgG, and are associated with macroglobulinemia and chronic active hepatitis. Type III are mixtures of polyclonal IgM and polyclonal IgG. These are found in a wide variety of disorders.

A high percentage of patients with cryoglobulinemia have clinical symptoms, and of these the most common are vascular (ie, purpura and digital necrosis). Raynaud phenomenon is also common.

Patients with SLE who are rheumatoid factor-negative but cryoglobulin-positive are more likely to develop renal disease than those who are rheumatoid factor-positive and cryoglobulin-negative.

Custom Panel: No

PRODUCTION SCHEDULE

Turn Around Time: 4 to 8 days
Days Performed: Monday, Tuesday, Wednesday, Thursday, Friday
Sites Performed: LabCorp
PHL Test Code: CRYGL
EPIC Test Code: LAB3300
Send Out Test Code: 001594
Included Tests: Cryoglobulin qualitative; Reflex quantitation of cryogobulin, as percentage and Immunofixation of cryoprecipitate
CPT Coding: 82595 If reflex testing is performed, concomitant CPT codes/charges will apply.

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