Laboratory Test Information Guide

Details for Cryoglobulin Serum and Cryofibrinogen Plasma Panel

Test Name: Cryoglobulin Serum and Cryofibrinogen Plasma Panel
Alternate Name(s): Cryoglobulin, Serum
Cryofibrinogen, Plasma
Laboratory: Clinical Immunology
Specimen Type: 3 x 6 mL Red Top Vacutainer tubes

2 x 4 mL Lavender Top Vacutainer tubes

1 x 4.5 ml Green Top Vacutainer tube (Note: this tube does not need to be placed in thermos)
Collection Information: Fasting samples preferred but not mandatory.

Caution: Specimen is not acceptable when drawn on a patient receiving heparin or any other anti-coagulant. Heparin (Dalteparin) needs to be stopped 24 hours and Lovenox needs to be stopped 35 hours before sample can be collected.

Collection Time: Monday-Friday, no STAT holidays or weekends.

Prior to Collection:
• City-wide: Call Core Lab to request a thermos.
• Provide name/unit location

Sample Collection Instructions:

• Collect and fill 3 red top and 2 lavender tubes until the vacuum exhausts
• Collect and fill green top tube until the vacuum exhausts, (this tube does not need to be placed in thermos)
• Mix well
• Open lid of thermos, place labelled tubes inside and immediately close

Post Sample Collection (send to Lab ASAP):
• City-wide: deliver to Core Lab (or call portering to deliver to Core Lab)

Sample Collection Instructions for Regional Sites:
3 x 6 ml Red Top Vacutainer tubes
2 x 4 ml Mauve Top Vacutainer tubes
The specimen tubes must remain at 37°C until the serum and plasma have been separated.

1 x 4.5 ml Green (Lithium Heparin) Top Vacutainer tube
Centrifuge and separate the plasma into aliquot tubes; store/ship at 4-8 degrees.
Test Schedule: Monday-Thursday. No STAT holidays.
Turnaround time from when specimen
is received in testing laboratory:
Negatives: 10 days
Positives: 14 days
Reference Range: Negative
Effective Date: 2020-10-28
Revised Date: 2020-12-09
Critical Value:  
Interpretive Comments: The final report for positive cryoglobulins will include:
1) Cryoglobulin type:
Type I - Monoclonal immunoglobulins. May be associated with Waldenström’s macroglobulinemia, multiple myeloma, monoclonal gammopathy of undetermined significance, and other lymphoproliferative diseases.
Type II - A mixture of immunoglobulins (usually monoclonal IgM kappa rheumatoid factor complexed with polyclonal IgG). Mainly associated with viral infection, particularly hepatitis C and human immunodeficiency virus infections. It can be seen in autoimmune diseases, such as Sjögren’s syndrome and systemic lupus erythematosus.
Type III - Polyclonal immunoglobulins. May be associated with chronic infections (hepatitis, human immunodeficiency, Epstein-Barr virus, and cytomegalovirus), as well as autoimmune diseases. This disorder may be a precursor to type II cryoglobulinemia.

2) Cryoglobulin concentration (g/L).

3) IgG, IgA and IgM concentrations in cryoprecipitate (g/L).
Special Processing: Immediately after the blood draw, place in a thermos filled with sand at 37°C. Arrange for rapid transport of the thermos to the Core Lab.
Comments: Immunofixation for identification of cryoprecipitate will only be performed on new cryoglobulin and cryofibrinogen positive samples, once per patient.
Method of Analysis: An aliquot of serum and an aliquot of plasma are incubated at 4°C for 10 days to exam if cryoprecipitate is present.

For positive cryoprecipitate samples, cryocrit is measured.
If cryocrit is ≥0.01 g/L, immunofixation is performed to identify the type of immunoglobulins, or to confirm the presence of cryofibrinogen.

Concentrations of IgG, IgA and IgM in cryoprecipitate are measured by Turbidimetry.
Critical Information Required: Is the patient on heparin therapy?
Storage & Shipment: The blood tubes must remain at 37°C until serum and plasma have been separated. After separation, the specimen can be stored or shipped at ambient temperature or refrigerated.
SRA – see specific procedure in OMNI
System Codes: 
Referred To:  

Questions? Comments? Contact Laura Gopaul