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.

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