Test Code GNPRC Protein C Deficiency, PROC Gene, Next-Generation Sequencing, Varies
Ordering Guidance
This test should only be considered if clinical and family history, initial coagulation screens, and initial protein C activity and antigen tests indicate a diagnosis of antithrombin deficiency (see Testing Algorithm). This test does not measure protein C activity or antigen levels.
For assessment of protein C activity, order CFX / Protein C Activity, Plasma. If protein C activity is low, protein C antigen testing could help distinguish between type I and type II deficiencies; order PCAG / Protein C Antigen, Plasma.
For assessment of protein C antigen, order PCAG / Protein C Antigen, Plasma.
If genetic testing for hereditary blood clotting disorders using a larger panel is desired, a 16-gene comprehensive thrombosis panel is available; order GNTHR / Thrombosis Disorders, Comprehensive Gene Panel, Next-Generation Sequencing, Varies.
Testing for the PROC gene as part of a customized panel is available. For more information see CGPH / Custom Gene Panel, Hereditary, Next-Generation Sequencing, Varies.
Targeted testing for familial variants (also called site-specific or known variants testing) is available for variants identified in the PROC gene. See FMTT / Familial Variant, Targeted Testing, Varies. To obtain more information about this testing option, call 800-533-1710.
Shipping Instructions
Specimen preferred to arrive within 96 hours of collection.
Necessary Information
Rare Coagulation Disorder Patient Information is required. Testing may proceed without the patient information, however, the information aids in providing a more thorough interpretation. Ordering providers are strongly encouraged to fill out the form and send with the specimen.
Specimen Required
Specimen Type: Whole blood
Patient Preparation: A previous bone marrow transplant from an allogenic donor will interfere with testing. Call 800-533-1710 for instructions for testing patients who have received a bone marrow transplant.
Container/Tube:
Preferred: Lavender top (EDTA)
Acceptable: Yellow top (ACD)
Specimen Volume: 3 mL
Collection Instructions:
1. Invert several times to mix blood.
2. Send whole blood specimen in original tube. Do not aliquot.
Specimen Stability Information: Ambient (preferred) 4 days/Refrigerated
Forms
1. Rare Coagulation Disorder Patient Information (T824) is required.
2. New York Clients-Informed consent is required. Document on the request form or electronic order that a copy is on file. The following documents are available:
-Informed Consent for Genetic Testing (T576)
-Informed Consent for Genetic Testing (Spanish) (T826)
3. If not ordering electronically, complete, print, and send an Coagulation Test Request (T753) with the specimen.
Useful For
Evaluating protein C deficiency in patients with a personal or family history suggestive of this hereditary thrombophilia
Confirming a diagnosis of autosomal dominant protein C deficiency with the identification of a known or suspected disease-causing alteration in the PROC gene
Confirming a diagnosis of autosomal recessive severe protein C deficiency with the identification of homozygous or compound heterozygous disease-causing alteration(s) in the PROC gene
Determining the disease-causing alteration(s) within the PROC gene to delineate the underlying molecular defect in a patient with a laboratory diagnosis of protein C deficiency
Prognosis and risk assessment based on the genotype-phenotype correlations
Ascertaining the variant status of family members related to an individual with a confirmed PROC variant for the purposes of informing clinical management and genetic counseling
Carrier testing for close family members of an individual with a diagnosis of autosomal recessive severe protein C deficiency
This test is not intended for prenatal diagnosis.
Method Name
Sequence Capture and Targeted Next-Generation Sequencing (NGS) followed by Polymerase Chain Reaction (PCR) and Sanger Sequencing
Reporting Name
PROC Gene, Full Gene NGSSpecimen Type
VariesSpecimen Minimum Volume
1 mL
Specimen Stability Information
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Varies | Varies |
Reject Due To
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.Clinical Information
Hereditary protein C deficiency is a rare inherited blood clotting disorder (thrombophilia) associated with germline variants in the PROC gene. Protein C is an important component of the body’s natural anticoagulant system. A deficiency results in an unchecked clotting cascade and an increased risk of thromboembolism.(1)
Individuals who are heterozygous for a disease-causing variant in PROC have mild protein C deficiency, which is inherited in an autosomal dominant manner. Mild protein C deficiency is characterized by an increased risk for venous thromboembolism and warfarin-induced skin necrosis. The coinheritance of additional thrombotic risk factors (eg, factor V Leiden) can compound the clotting risk. The estimated prevalence of mild protein C deficiency is between 1 in 200 to 1 in 500.(1-3)
Homozygosity or compound heterozygosity for disease-causing variants in PROC is associated with severe protein C deficiency, which is extremely rare (estimated prevalence of 1 in 500,000 to 1 in 750,000) and is inherited in an autosomal recessive manner. This disorder typically presents with purpura fulminans and disseminated intravascular coagulation within 72 hours of birth but, occasionally, in later infancy. Infants with severe deficiency typically have protein C levels that are virtually undetectable.(1,2,4)
Several causes of acquired (nongenetic) protein C deficiency should be excluded prior to genetic testing, including vitamin K deficiency, oral anticoagulation with coumarin compounds, liver disease, and intravascular coagulation and fibrinolysis/disseminated intravascular coagulation.(2,5)
The British Society for Haematology provides guidelines regarding diagnosis, management, and laboratory testing for individuals with hereditary thrombophilias, including protein C deficiency.(6)
Reference Values
An interpretive report will be provided.
Day(s) Performed
Varies
Report Available
28 to 42 daysPerforming Laboratory
Mayo Clinic Laboratories in RochesterTest Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
81479