| 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.
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| Requisition: | GENERAL LABORATORY REQUISITION |
| Test Schedule: | Monday-Thursday. No STAT holidays. |
Turnaround time from when specimen
is received in testing laboratory: | | Routine | 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).
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| 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.
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| 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
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| System Codes: | | |
| Referred To: | |
