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Test Name:
Platelet Antigen Genotyping Panel

• SBMF No:
  45432
• Performance Lab Name:
  ARUP Laboratories
• Test Mnemonic:
  HPA PAN
• ABN:
  Required – Not FDA-Approved
• CPT Code:
  83891; 83896x14; 83898x7; 83912
• Ref Lab Test No:
  0051308
• Test Includes:
  Platelet Antigen 1 Genotyping (HPA-1)
  Platelet Antigen 2 Genotyping (HPA-2)
  Platelet Antigen 3 Genotyping (HPA-3)
  Platelet Antigen 4 Genotyping (HPA-4)
  Platelet Antigen 5 Genotyping (HPA-5)
  Platelet Antigen 6 Genotyping (HPA-6)
  Platelet Antigen 15 Genotyping (HPA-15)
• Spec Type:
  Whole blood
• Spec Container:
  Lavender top (EDTA) or Pale Yellow top (ACD-A or B) tube
• Alt Spec Type:
  Amniotic fluid or Cultured amniocytes
• Alt Spec Container:
  Amniotic fluid: Sterile plastic tube with screw-top cap
  Cultured amniocytes: Two T-25 Flasks
• Pref Vol:
  Whole blood: 3.0 mL
  Amniotic fluid: 10.0 mL
• Min Vol:
  Whole blood: 1.0 mL
  Amniotic fluid: 5.0 mL
• Fasting:
  No
• Patient Prep:
  Counseling and informed consent are recommended for genetic testing
  Forms required:
  Informed Consent for Molecular Genetic Testing
  Patient History for Molecular Genetic Testing
• Spec Collect:
  Blood: Routine venipuncture
  Amniotic fluid: Collected by physician
• Spec Process:
  

  Whole blood:
  Gently invert tube to mix blood with the anticoagulant
  Do not centrifuge
  Do not remove plasma from cells
  Forward entire tube of unprocessed whole blood to the laboratory

  Amniotic fluid:
  Do not centrifuge

  Cultured amniocytes:
  Fill flasks with culture media
  Transport two T-25 flasks at 80% confluency of cultured amniocytes
  Backup cultures must be retained at the client's institution until testing is complete
  If the client is unable to culture amniocytes, this can be arranged by contacting ARUP Client Services

• Spec Store Transport:
  Whole blood: Room temperature (72 hours) or refrigerated
  Cultured cells or amniotic fluid: Room temperature
• Spec Stability:
  

  Whole blood:
  72 hours room temperature (20-30°C)
  1 week refrigerated (2-8°C)
  Frozen (-20°C): Unacceptable

  Amniotic fluid or cultured amniocytes:
  48 hours room temperature (20-30°C)
  Refrigerated (2-8°C): Unacceptable
  Frozen (-20°C): Unacceptable

• Spec Remarks:
  Cultured Amniocytes: CRITICAL ROOM TEMPERATURE – Must be received at ARUP within 48 hours of shipment due to lability of cells
• Methodology:
  Polymerase Chain Reaction (PCR)
  Fluorescence Monitoring
• Clinical Significance:
  Refer to:
  
• Reference Range:
  

  By report

  Interpretive Data:
  Background Information for Platelet Antigen Genotyping Panel:
  Characteristics: Spontaneous fetal intracranial bleeding in 20 percent of severe perinatal alloimmune thrombocytopenia (PAT) affected pregnancies; risk of fetal death. Post-transfusion purpura in transfusion recipients with antibodies to a specific platelet antigen.
  Incidence: PAT occurs in 1 in 5000 births.
  Inheritance: Codominant expression of a and b alleles.
  Cause: Women homozygous for a rare b HPA allele with antibodies to the common a allele have a 50 percent risk for an affected pregnancy if her partner is heterozygous for a allele and 100 percent if her partner is homozygous for a allele.
  Mutations Tested: HPA 1, 2, 3, 4, 5, 6, 15 a (common) and b (variant) alleles.
  Clinical Sensitivity: 98 percent.
  Methodology: Polymerase chain reaction (PCR) followed by melting analysis using fluorescent resonance energy transfer (FRET) probes.
  Analytical Sensitivity and Specificity: 99 percent.
  Limitations: Mutations other than in HPA 1, 2, 3, 4, 5, 6, 15 will not be detected; furthermore, mutations within the primer or probe regions could affect this assay.

  This test is performed pursuant to an agreement with Roche Molecular Systems, Inc.

• Additional Test Info:
  

  Genetic Compliance Statement:
  The performance characteristics of this test were validated by ARUP Laboratories. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test. However, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. ARUP is authorized under Clinical Laboratory Improvement Amendments (CLIA) and by all states to perform high-complexity testing.

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

• Day Run:
  Mon, Thu
• Time Reported:
  3-8 days
• Test Type:
  GENETIC