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Test Name:
Platelet Associated Antibodies, Direct Assay

• SBMF No:
  44007
• Performance Lab Name:
  ARUP Laboratories
• Test Mnemonic:
  PLATE ASSO
• ABN:
  Not required
• CPT Code:
  86023x2
• LOINC Code:
  29497-5; 29498-3
• Ref Lab Test No:
  0095614
• Also Known As:
  Anti-Platelet Antibodies, Direct Assay
  Platelet Associated Immunoglobulins
• Also See:
  44477 Platelet Antibodies, Indirect
• Spec Type:
  Whole blood
• Spec Container:
  Two (2) Lavender top (EDTA) tubes
• Pref Vol:
  10.0 mL
• Min Vol:
  5.0 mL
• Fasting:
  No
• Spec Collect:
  Do not collect samples on a weekend or holiday
  Routine venipuncture
• Spec Process:
  Gently invert tube to mix
  Do not centrifuge
  Do not remove plasma from cells
  Do not refrigerate or freeze
• Spec Store Transport:
  Room temperature
• Spec Stability:
  48 hours room temperature (20-30°C)
  Refrigerated (2-8°C): Unacceptable
  Frozen (-20°C): Unacceptable
• Spec Reject:
  Clotted, hemolyzed, refrigerated, or frozen sample
  Samples older than 48 hours
• Spec Remarks:
  CRITICAL ROOM TEMPERATURE
  Samples must be received at ARUP and analyzed with 48 hours of collection
  Required amount of blood may be dependent on platelet count
• Methodology:
  Qualitative Flow Cytometry
• Reference Range:
  

  IgG: Negative
  IgM: Negative

  Interpretive Data:
  Negative (IgG & IgM): No excess antibodies were associated with the patient's platelets. An immune cause of thrombocytopenia is unlikely.
  Positive (IgG and/or IgM): An increase in platelet associated immunoglobulin is noted. An immune cause of thrombocytopenia should be considered. However, many conditions can result in an increase in platelet associated antibodies; for example, IgM rheumatoid factor antibodies.
  Strong Positive (IgG and/or IgM): A definite increase in platelet associated immunoglobulin is noted and an immune cause of thrombocytopenia should be considered. However, many conditions can result in an increase in platelet associated antibodies; for example, IgM rheumatoid factor antibodies.

  Note:
  Detection of platelet-associated IgG and/or IgM may be used to separate thrombocytopenia of immune origin from nonimmune origin. Most patients with ITP have abnormally high levels of IgG associated with their platelets. Occasionally patients will have normal IgG levels but abnormally high levels of IgM. Dual staining and flow cytometric analysis ensures that only platelets are analyzed and relatively small volumes of blood are required. This assay does not distinguish between autoantibodies and alloantibodies, nor does it identify specific types of antiplatelet antibodies, such as those against HPA-1a. Refer to Platelet Antibodies, Indirect (44477).

• Additional Test Info:
  ASR Compliance Statement:
  Analyte specific reagents (ASR) are used in many laboratory tests necessary for standard medical care and generally do not require U.S. Food and Drug Administration (FDA) approval or clearance. This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. This test should not be regarded as investigational or for research use.
• Day Run:
  Sun-Sat (daily)
• Time Reported:
  3-4 days
• Test Type:
  FLOW