Ordering Recommendation

Screens for genetic susceptibility for venous thromboembolism (VTE) or myocardial infarction (MI) in individuals with a personal or family history of thrombotic events. Aids risk/benefit assessment for preventive or therapeutic interventions for VTE or MI.

Mnemonic
PAI-1 GENO
Methodology

Polymerase Chain Reaction/Fluorescence Monitoring

Performed

Mon, Thu

Reported

7-10 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Lavender (EDTA), pink (K2EDTA), or yellow (ACD Solution A or B).

Specimen Preparation

Transport 3 mL whole blood. (Min: 1 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions
Remarks
Stability

Ambient: 72 hours; Refrigerated: 1 week; Frozen: Unacceptable

Reference Interval

By report

Interpretive Data

Background Information: Plasminogen Activator Inhibitor-1, PAI-1 (SERPINE1) Genotyping:
Characteristics:
The 4G allele within in the promoter region of the PAI-1 (SERPINE1) gene is associated with higher plasma PAI-1 activity when compared with the 5G allele. Heterozygosity or homozygosity for the 4G allele confers a risk for venous thromboembolism (VTE), especially in individuals with other thrombophilic risk factors, as well as a risk for myocardial infarction. 
Frequency of the 4G Allele:
Caucasian 0.52, Hispanic 0.38, African-American 0.13-0.28.
Variant Tested: The PAI-1 promoter 4G/5G polymorphism located in the promoter region of the SERPINE1 gene. NM_000602.3(SERPINE1)  c.-817dupG (from start of translation).
Inheritance:
Autosomal dominant.
Clinical sensitivity:
Unknown.
Methodology:
Polymerase chain reaction and fluorescence monitoring.
Analytical Sensitivity and Specificity:
99 percent.
Limitations:
Variants in the PAI-1 (SERPINE1) gene, other than the 4G/5G polymorphism, are not evaluated.  Diagnostic errors can occur due to rare sequence variations.

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Counseling and informed consent are recommended for genetic testing. Consent forms are available online.

Compliance Category

Laboratory Developed Test (LDT)

Note
Hotline History
N/A
CPT Codes

81400

Components
Component Test Code* Component Chart Name LOINC
2004981 PAI-1 Specimen 31208-2
2004982 PAI-1 Interpretation 60577-4
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • FACV
  • PAI
  • PAI-1
  • Plasminogen Activator
  • PT PCR
  • SERPINE1
  • Thrombotic Risk Panel
Plasminogen Activator Inhibitor-1, PAI-1 (SERPINE1) Genotyping