Test Catalog

Test Id : APCRR

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Activated Protein C Resistance V, with Reflex to Factor V Leiden, Blood and Plasma

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Evaluating patients with incident or recurrent venous thromboembolism (VTE)

 

Evaluating individuals with a family history of VTE

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

Test Id Reporting Name Available Separately Always Performed
APCRV Activated Protein Resistance V, P Yes Yes
SC018 Whole Blood No Yes

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
F5DNA Factor V Leiden (R506Q) Mutation, B Yes No
F5DNI APCRV/F5DNA Summary Interpretation No No

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If the assay ratio is abnormal, then factor V Leiden variant analysis will be performed at an additional charge.

 

When the activated protein C resistance V is abnormal or indeterminate and the factor V Leiden variant assay is performed, a summary interpretation will be provided.

Method Name
A short description of the method used to perform the test

Optical Clot-Based

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

APCRV, w/Reflex, P

Aliases
Lists additional common names for a test, as an aid in searching

Activated Protein CV deficient

APCRV (Activated Protein C Resistance V)

Soft-APCRR

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If the assay ratio is abnormal, then factor V Leiden variant analysis will be performed at an additional charge.

 

When the activated protein C resistance V is abnormal or indeterminate and the factor V Leiden variant assay is performed, a summary interpretation will be provided.

Specimen Type
Describes the specimen type validated for testing

Plasma Na Cit

Whole blood

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Blood and plasma are required.

 

Patient Preparation: Fasting preferred

 

Specimen Type: Whole blood

Container/Tube:

Preferred: Lavender top (EDTA)

Acceptable: Yellow top (ACD) or light-blue top (3.2% sodium citrate)

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 Type: Platelet-poor plasma

Collection Container/Tube: Light-blue top (3.2% sodium citrate)

Submission Container/Tube: Plastic vial, polypropylene preferred

Specimen Volume: 1 mL

Collection Instructions:

1. For complete instructions, see Coagulation Guidelines for Specimen Handling and Processing.

2. Within 4 hours of collection, centrifuge, transfer all plasma into a plastic vial, and centrifuge plasma again.

3. Aliquot plasma into separate plastic vial leaving 0.25 mL in the bottom of centrifuged vial.

4. Freeze plasma aliquot immediately at -20 degrees C, or ideally, at -40 degrees C or below.

Additional Information:

1. Double-centrifuged specimen is critical for accurate results as platelet contamination may cause spurious results.

2. Each coagulation assay requested should have its own vial.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

1. 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)

2. Coagulation Patient Information (T675)

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

Plasma: 0.5 mL; Whole blood: 3 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Plasma Na Cit Frozen 14 days
Whole blood Ambient (preferred) 14 days
Frozen 14 days
Refrigerated 14 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Evaluating patients with incident or recurrent venous thromboembolism (VTE)

 

Evaluating individuals with a family history of VTE

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If the assay ratio is abnormal, then factor V Leiden variant analysis will be performed at an additional charge.

 

When the activated protein C resistance V is abnormal or indeterminate and the factor V Leiden variant assay is performed, a summary interpretation will be provided.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Protein C, a part of the natural anticoagulant system, is a vitamin K-dependent protein zymogen (molecular weight = 62,000 Da) that is synthesized in the liver and circulates at a plasma concentration of approximately 5 mcg/mL. Protein C is activated to activated protein C (APC) via proteolytic cleavage by thrombin bound to thrombomodulin, an endothelial cell surface membrane protein. APC downregulates the procoagulant system by proteolytically inactivating procoagulant factors Va and VIIIa. Protein S, another vitamin K-dependent coagulation protein, catalyzes APC inactivation of factors Va and VIIIa. APC interacts with and proteolyzes factors V/Va and VIII/VIIIa at specific APC binding and cleavage sites, respectively. Resistance to activated protein C (APC resistance) is a term used to describe abnormal resistance of human plasma to the anticoagulant effects of human APC. APC resistance is characterized by a reduced anticoagulant response of patient plasma after adding a standard amount of APC. For this assay, the activated partial thromboplastin time fails to prolong significantly after the addition of APC.

 

The vast majority of individuals with familial APC resistance have a specific alteration in the procoagulant factor V gene (F5) encoding for a p.Arg534Gln substitution in the heavy chain of factor V (formerly R506Q). This glutamine to arginine amino acid change alters an APC cleavage site on factor V such that factor V/Va is partially resistant to inactivation by APC. The carrier frequency for the factor V Leiden variant varies depending on the population. Approximately 5% of asymptomatic White Americans of non-Hispanic ancestry are heterozygous carriers. In contrast, the carrier frequency among African Americans, Asian Americans, and Native Americans is less than 1%, and the carrier frequency for Hispanics is intermediate (2.5%). The carrier frequency can be especially high (up to 14%) among White individuals of Northern European or Scandinavian ancestry. Homozygosity for factor V Leiden is much less common but may confer a substantially increased risk for thrombosis. The degree of abnormality of the APC-resistance assay correlates with heterozygosity or homozygosity for the factor V Leiden variant; homozygous carriers have a very low APC-resistance ratio (eg, 1.1-1.4), while the ratio for heterozygous carriers is usually 1.5 to 1.8.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

ACTIVATED PROTEIN C RESISTANCE V RATIO

> or =2.3

Pediatric reference range has neither been established nor is available in scientific literature. The adult reference range likely would be applicable to children older than 6 months.

Interpretation
Provides information to assist in interpretation of the test results

An activated protein C (APC) resistance ratio below 2.3 suggests abnormal resistance to APC of hereditary origin.

 

If the screening APC resistance test is abnormal, DNA-based testing for the factor V Leiden variant (p.Arg534Gln, formerly R506Q) is performed to confirm or exclude hereditary APC-resistance.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This assay is highly sensitive and specific for inherited activated protein C (APC) resistance, most commonly due to the factor V Leiden variant, but will not detect patients with acquired APC resistance. Persons with acquired APC resistance are at similar risk for venous thromboembolism.

 

Preanalytical conditions of the patient and the blood specimen are extremely important for reliable performance and interpretation of testing for APC resistance. Plasma specimens demonstrating prolongation of clotting times (prothrombin time, activated partial thromboplastin time) for reasons other than anticoagulant effects (eg, lupus-like anticoagulants or specific coagulation factor inhibitors) generally cannot be reliably tested for the presence or absence of APC resistance. Proper preparation of the plasma specimen is extremely important to help ensure accuracy of results and interpretation.

 

This assay has greater than 99% sensitivity for detecting the presence of the factor V Leiden variant. Discrepant results of plasma-based activated protein C resistance ratio (APCRV) and DNA-based factor V Leiden testing may occur in recipients of liver or allogeneic hematopoietic stem cell transplants, or due to anticoagulant effects, such as excess heparin, direct thrombin inhibitors argatroban (Acova), bivalirudin (Angiomax) or dabigatran (Pradaxa); or direct factor Xa inhibitors rivaroxaban (Xarelto), apixaban (Eliquis), and edoxaban (Savaysa); or a sample mix up. Suggest clinical correlation. If DNA-based testing for the factor V Leiden variant is clinically indicated, call 800-533-1710.

 

Although the APC-resistance assay can be performed in the absence of other coagulation tests and clinical information, it is most reliably performed as part of a consultative coagulation test panel with interpretive reporting (including appropriate testing of the same specimen to evaluate for the presence or absence of coagulation abnormalities or conditions that may affect interpretation of the APC-resistance assay). This test is included among a panel of tests; see AATHR / Thrombophilia Profile, Plasma and Whole Blood.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Nichols WL, Heit JA. Activated protein C resistance and thrombosis. Mayo Clin Proc. 1996;71(9):897-898

2. Dahlback B. Resistance to activated protein C as risk factor for thrombosis: molecular mechanisms, laboratory investigation, and clinical management. Semin Hematol. 1997;34(3):217-234

3. Rodeghiero F, Tosetto A. Activated protein C resistance and factor V Leiden mutation are independent risk factors for venous thromboembolism. Ann Intern Med. 1999;130(8):643-650. doi:10.7326/0003-4819-130-8-199904200-00004

4. Grody WW, Griffin JH, Taylor AK, Korf BR, Heit JA; ACMG Factor V. Leiden Working Group. American College of Medical Genetics consensus statement on factor V Leiden mutation testing [published correction appears in Genet Med. 2021 Dec;23(12):2463]. Genet Med. 2001;3(2):139-148. doi:10.1097/00125817-200103000-00009 5. Press RD, Bauer KA, Kujovich JL, Heit JA. Clinical utility of factor V Leiden (R506Q) testing for the diagnosis and management of thromboembolic disorders. Arch Pathol Lab Med. 2002;126(11):1304-1318. doi:10.5858/2002-126-1304-CUOFVL

6. Yohe S, Olson J: Thrombophilia: Assays and interpretation. In: Kottke-Marchant K, Davis B, eds. Laboratory Hematology Practice. Blackwell Publishing; 2012:492-508

Method Description
Describes how the test is performed and provides a method-specific reference

This assay is performed using the HemosIL Factor V Leiden (APC Resistance V) Kit on the Instrumentation Laboratory ACL TOP instrument. The method uses a modified activated partial thromboplastin time (aPTT) test to detect activated protein C (APC) resistance. The plasma specimen is prediluted in factor V-deficient plasma. Then the aPTT test is performed by incubating patient plasma with a standardized amount of platelet-like phospholipids and activator of the contact factors of the intrinsic coagulation pathway, followed by recalcification of plasma and measurement of clotting time. The ratio of the aPTT test with and without added APC is reported as the APC resistance (or sensitivity) ratio.(Package insert: HemosIL Factor V Leiden [APC Resistance V]. Instrumentation Laboratory Company; Rev 11/2017)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

4 to 7 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Plasma: 7 days: Whole blood: 2 weeks

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

See Individual Test IDs

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

85307

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
APCRR APCRV, w/Reflex, P 13590-5
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
APCR APCRV Ratio 13590-5
INT55 Interpretation 48591-2
SC018 Whole Blood No LOINC Needed

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | PHP Pdf | CMS Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports