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Test Code F10NG Factor X Deficiency, F10 Gene, Next-Generation Sequencing, Varies

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Genetic confirmation of a factor X deficiency diagnosis with the identification of a known or suspected pathogenic alterations in the F10 gene

 

Carrier testing for close family members of an individual with a factor X deficiency diagnosis

 

This test is not intended for prenatal diagnosis.

Method Name

Custom Sequence Capture and Targeted Next-Generation Sequencing (NGS) followed by Polymerase Chain Reaction (PCR) and Sanger Sequencing when appropriate


Advisory Information


Genetic testing for factor X deficiency should only be considered after coagulation screening is performed and if factor X activity is less than 65% of normal (Note: reference ranges may vary depending on the locally established reference range).



Shipping Instructions


Ambient and refrigerated specimens must arrive within 7 days (168 hours of draw), and frozen specimens must arrive within 14 days (336 hours of draw).

 

Collect and package specimen as close to shipping time as possible.



Necessary Information


Rare Coagulation Disorder Patient Information is required, see Special Instructions. 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


Submit only 1 of the following specimens:

 

Specimen Type: Peripheral blood

Container/Tube:

Preferred: Lavender top (EDTA)

Acceptable: Yellow top (ACD) or green top (sodium citrate)

Specimen Volume: 3 mL

Collection Instructions:

1. Invert several times to mix blood.

2. Send specimen in original tube.

Specimen Stability: Ambient (preferred)/Refrigerated/Frozen

 

Specimen Type: Extracted DNA

Container/Tube: 1.5- to 2-mL tube

Specimen Volume: Entire specimen

Collection Instructions:

1. Label specimen as extracted DNA and source of specimen.

2. Provide indication of volume and concentration of the DNA.

Specimen Stability: Frozen (preferred)/Refrigerated/Ambient


Reporting Name

F10 Gene, Full Gene NGS

Specimen Type

Varies

Specimen Minimum Volume

Blood: 1 mL
Extracted DNA: 100 mcL at 50 ng/mcL concentration

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Ambient (preferred) 7 days
  Frozen  14 days
  Refrigerated  7 days

Reject Due To

Gross hemolysis OK
Gross lipemia OK

Reference Values

An interpretive report will be provided.

Day(s) and Time(s) Performed

Performed weekly; Varies

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

81479

LOINC Code Information

Test ID Test Order Name Order LOINC Value
F10NG F10 Gene, Full Gene NGS 92990-1

 

Result ID Test Result Name Result LOINC Value
113052 F10NG Result 50397-9
113046 Alterations Detected 82939-0
113045 Interpretation 69047-9
113047 Additional Information 48767-8
113048 Method 85069-3
113049 Disclaimer 62364-5
113050 Panel Gene List 48018-6
113051 Reviewed By 18771-6

Forms

1. Rare Coagulation Disorder Patient Information (T824) is required, see Special Instructions. Fax the completed form to 507-284-1759.

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 in Special Instructions:

-Informed Consent for Genetic Testing (T576)

-Informed Consent for Genetic Testing-Spanish (T826)

3. If not ordering electronically, complete, print, and send a Coagulation Test Request (T753) with the specimen.

Testing Algorithm

The clinical workup for factor X deficiency (F10D) begins with special coagulation testing for factor X. See F_10 / Coagulation Factor X Activity Assay, Plasma.

 

Genetic testing for F10D is indicated if:

-Factor X clotting activity is reduced (less than 80% of normal)

-Acquired causes of factor X deficiency have been excluded (eg, liver disease, warfarin therapy, vitamin K deficiency, systemic amyloidosis, and inhibitors)