Ordering Instructions

Order LAB4603 in Epic if both Factor 5 and Factor 2 requested.

Special Instructions

Test should be ordered through a genetic counselor, or medical geneticist. Patient must be counseled regarding this test: Counseling is available through the Molecular Diagnostics genetic counselor at 612-273-8948. A signed informed consent in the patient's medical record is required; the consent should not be sent to the laboratory. The link to the Genetic Testing Consent Form is provided as a convenience for the providers and genetic counselors.



Bone Marrow Transplant Patients; If a patient is the recipient of an allogeneic transplant, this test must be done on a pre-transplant sample. Contact the Molecular Diagnostics lab to see if a pre-transplant sample is available.

MRL Ordering Instructions

MN Statute:  Obtain and retain genetic testing informed consent in your patient's chart.

Compliance Statement

Testing performed on Yellow ACD-A additive: This test was developed and its performance characteristics determined by M Health-Fairview, Molecular Diagnostics Laboratory. It has not been cleared or approved by the FDA. The laboratory is regulated under CLIA as qualified to perform high-complexity testing. This test is used for clinical purposes. It should not be regarded as investigational or for research

Turnaround Time

Results are reported within 5 days.

Use

Detection of the Factor 5 Leiden (R506Q) mutation that has been demonstrated to be a risk factor for inherited thrombophilia.

Interpretive Data

Zygosity will be reported if the mutation is detected.
The presence of the Factor V R506Q (1691G>A) (Leiden) mutation is an indication of an increased risk of developing a thrombosis. The extent of this risk is dependent upon several other known thrombophilic risk factors including smoking, obesity and the use of oral contraceptives.

Specimen Type

Blood

Collection Containers

Purple (EDTA)
Alternate Containers:  Yellow (ACD, Solution A) tube available from laboratory

Collection Volume

5 mL

Minimum Collection Volume

2 mL

Specimen Preparation

Do not process whole blood. Store at refrigerated temperature.

Unacceptable Conditions

Frozen or clotted specimen, incorrect anticoagulant, specimen more than 5 days old. Testing requested on a sample punctured by an automated instrument. Add on testing to hematology samples is not accepted. DNA extracted at non-CLIA certified (or equivalent) lab.
Patients are only tested ONCE; if duplicate sample is collected, testing is canceled, credited and original results and collection date reported. Contact 612-273-8445 with questions.

Shipping Instructions

Ship at refrigerated temperature.

Containers

Purple (EDTA)

Alternate Containers

Yellow (ACD, Solution A) Tube, available from laboratory

Reference Interval

Normal

Interpretive Data

Zygosity will be reported if the mutation is detected.
The presence of the Factor V R506Q (1691G>A) (Leiden) mutation is an indication of an increased risk of developing a thrombosis. The extent of this risk is dependent upon several other known thrombophilic risk factors including smoking, obesity and the use of oral contraceptives.

CPT Disclaimer

The Current Procedural Terminology (CPT) Codes published in the M Health Fairview Test Directory are based on American Medical Association (AMA) guidelines and are provided for informational purposes only. CPT codes are provided only as guidance to assist clients with billing. CPT coding is the responsibility of the billing party. M Health Fairview Laboratories does not assume responsibility for billing errors due to reliance on the CPT codes listed in this Test Directory. Charges may vary due to reflexing, susceptibilities, specimen source, patient age, methodology requirements, etc..

Patient Price Inquiries

Requester Contact Information
Patient and UMP/FV Care Team Fairview Consumer Line at 612-672-1048
MRL Outreach Client dept-mrl-business-assessment@fairview.org
Research research@fairview.org

CPT Codes

CPTQtyHC HospitalPR ClinicNote
81241130081241028124102F5 LEIDEN

Methodology

Qualitative genotyping RT-PCR

MRL Test Build

Test NameComponentRequiredDescriptionTypeLOINC
LAB346  Factor 5 Leiden MutationOrderable 
 SRC_1001 Blood specimen source:Prompt 
 1230012341 Factor 5 Leiden Mutation AnalysisResult21668-9

Data Type / Multiple Choice Response

SRC_1001
Blood specimen source:
Arm, Left|Arm, Right|Hand, Left|Hand, Right|Blood, Capillary|Other|Peripheral Blood
Default: Peripheral Blood

Contact

For questions regarding the test code Interface Map, please contact DEPT-LAB-CLIENT-INTERFACE@fairview.org
Ordering

Ordering Instructions

Order LAB4603 in Epic if both Factor 5 and Factor 2 requested.

Special Instructions

Test should be ordered through a genetic counselor, or medical geneticist. Patient must be counseled regarding this test: Counseling is available through the Molecular Diagnostics genetic counselor at 612-273-8948. A signed informed consent in the patient's medical record is required; the consent should not be sent to the laboratory. The link to the Genetic Testing Consent Form is provided as a convenience for the providers and genetic counselors.



Bone Marrow Transplant Patients; If a patient is the recipient of an allogeneic transplant, this test must be done on a pre-transplant sample. Contact the Molecular Diagnostics lab to see if a pre-transplant sample is available.

MRL Ordering Instructions

MN Statute:  Obtain and retain genetic testing informed consent in your patient's chart.

Compliance Statement

Testing performed on Yellow ACD-A additive: This test was developed and its performance characteristics determined by M Health-Fairview, Molecular Diagnostics Laboratory. It has not been cleared or approved by the FDA. The laboratory is regulated under CLIA as qualified to perform high-complexity testing. This test is used for clinical purposes. It should not be regarded as investigational or for research

Turnaround Time

Results are reported within 5 days.

Use

Detection of the Factor 5 Leiden (R506Q) mutation that has been demonstrated to be a risk factor for inherited thrombophilia.

Interpretive Data

Zygosity will be reported if the mutation is detected.
The presence of the Factor V R506Q (1691G>A) (Leiden) mutation is an indication of an increased risk of developing a thrombosis. The extent of this risk is dependent upon several other known thrombophilic risk factors including smoking, obesity and the use of oral contraceptives.
Collection & Processing

Specimen Type

Blood

Collection Containers

Purple (EDTA)
Alternate Containers:  Yellow (ACD, Solution A) tube available from laboratory

Collection Volume

5 mL

Minimum Collection Volume

2 mL

Specimen Preparation

Do not process whole blood. Store at refrigerated temperature.

Unacceptable Conditions

Frozen or clotted specimen, incorrect anticoagulant, specimen more than 5 days old. Testing requested on a sample punctured by an automated instrument. Add on testing to hematology samples is not accepted. DNA extracted at non-CLIA certified (or equivalent) lab.
Patients are only tested ONCE; if duplicate sample is collected, testing is canceled, credited and original results and collection date reported. Contact 612-273-8445 with questions.

Shipping Instructions

Ship at refrigerated temperature.
Containers

Containers

Purple (EDTA)

Alternate Containers

Yellow (ACD, Solution A) Tube, available from laboratory

Result Interpretation

Reference Interval

Normal

Interpretive Data

Zygosity will be reported if the mutation is detected.
The presence of the Factor V R506Q (1691G>A) (Leiden) mutation is an indication of an increased risk of developing a thrombosis. The extent of this risk is dependent upon several other known thrombophilic risk factors including smoking, obesity and the use of oral contraceptives.
Administrative

CPT Disclaimer

The Current Procedural Terminology (CPT) Codes published in the M Health Fairview Test Directory are based on American Medical Association (AMA) guidelines and are provided for informational purposes only. CPT codes are provided only as guidance to assist clients with billing. CPT coding is the responsibility of the billing party. M Health Fairview Laboratories does not assume responsibility for billing errors due to reliance on the CPT codes listed in this Test Directory. Charges may vary due to reflexing, susceptibilities, specimen source, patient age, methodology requirements, etc..

Patient Price Inquiries

Requester Contact Information
Patient and UMP/FV Care Team Fairview Consumer Line at 612-672-1048
MRL Outreach Client dept-mrl-business-assessment@fairview.org
Research research@fairview.org

CPT Codes

CPTQtyHC HospitalPR ClinicNote
81241130081241028124102F5 LEIDEN

Methodology

Qualitative genotyping RT-PCR
Interface Mapping

MRL Test Build

Test NameComponentRequiredDescriptionTypeLOINC
LAB346  Factor 5 Leiden MutationOrderable 
 SRC_1001 Blood specimen source:Prompt 
 1230012341 Factor 5 Leiden Mutation AnalysisResult21668-9

Data Type / Multiple Choice Response

SRC_1001
Blood specimen source:
Arm, Left|Arm, Right|Hand, Left|Hand, Right|Blood, Capillary|Other|Peripheral Blood
Default: Peripheral Blood

Contact

For questions regarding the test code Interface Map, please contact DEPT-LAB-CLIENT-INTERFACE@fairview.org
Private Details

Test Detail

Processing Key

Abbreviation
F5MA
Performing Lab
UMMC East Bank
Department
UM Molecular Diagnostics (M)
Test Search Categories
  • Molecular Diagnostics

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