Test Catalog

Test Id : FPAIG

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Plasminogen Activator Inhibitor-1, 4G/5G Genotyping (PAI-1 Polymorphism)

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Overview

Test Catalog

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

Polymerase chain reaction (PCR) and restriction fragment length polymorphism (RFLP) technologies.

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

PAI-1 Gene Polymorphism

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

PAI-1 4G/5G Polymorphism

PAI-1

Plasminogen Activator Inhibitor (FPAI-1), Gene Polymorphism

Specimen Type
Describes the specimen type validated for testing

Whole blood

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

Specimen Type: Whole Blood

Preferred: EDTA

Acceptable: ACD (Yellow top)

Specimen volume: 5 mL

Collection Instructions: Draw 5 mL whole blood in a lavender top (EDTA) or yellow top (ACD) tube. Send refrigerated.

Forms

New York Clients - Informed consent is required. Please document on the request form or electronic order that a copy is on file. An Informed Consent for Genetic Testing is available in Special Instructions.

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

1.00 mL

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

Hemolysis NA
Lipemia NA
Icteric NA
Other NA

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
Whole blood Refrigerated (preferred) 8 days
Ambient 8 days

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

The PAI-1 4G allele is an inherited characteristic. If the polymorphism is present in a heterozygous or homozygous fashion, we recommend that the patient and their family consider genetic counseling to obtain additional information on inheritance and to identify other family members at risk.

If a patient possesses two or more congenital or acquired risk factors, the risk of disease may rise to more than the sum of the risk ratios for the individual risk factors. For instance, a combination of the 4G/4G genotype and the insulin resistance syndrome may confer an increase in cardiovascular disease risk over that conferred by the presence of an isolated PAI-1 4G/4G polymorphism.

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

Genetic testing by PCR provides exceptionally high sensitivity and specificity. Incorrect genotyping results can be caused by rare polymorphisms in primer binding sites and to misidentification of specimens by collectors or laboratory personnel. This assay analyzes only the PAI 4G/5G locus and does not measure genetic abnormalities elsewhere in the genome.

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

Barcellona D. Thromb Haemost. 2003;90:1061.;Dossenbach-Glaninger. Clin Chem. 2003;49:1081.; Kohler et al. NEJM. 200;342:1792.; Margaglione M et al. Arterioscl Thromb and Vasc Bio. 1998;18:152.

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

Patient DNA was evaluated for the PAI-1 4G/5G promoter polymorphism, which is a single base pair guanine (4G/5G) deletion/insertion polymorphism, using polymerase chain reaction (PCR) technology and restriction fragment length polymorphism (RFLP).

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.

Wednesday, Saturday

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.

7-14 days

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

Esoterix Coagulation

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.

This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the Food and Drug Administration.

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.

81400

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
FPAIG PAI-1 Gene Polymorphism Not Provided
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.
Z4765 PAI-1 Locus 4G/5G Polymorphism Not Provided
Z4766 Results 52757-2
Z4767 Interpretation Not Provided
Z4768 Comments 77202-0

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