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LABORATORY AVERA SACRED HEART HOSPITAL 501 Summit • Yankton • SD 57078 668-8169 Technical Service Bulletin 2/14/2013 The laboratory is pleased to announce the introduction of a new technology for evaluating platelet function, the PFA-100. The PFA-100 is the first in vitro test system designed for clinical laboratory use that is capable of detection platelet dysfunction under high shear flow conditions in a small citrated whole blood sample. Two types of test cartridges are used with the system, Collagen/Epinephrine (COL/EPI) or Collagen/ADP (COL/ADP). The COL/EPI is the primary cartridge used to detect platelet dysfunction induced by intrinsic platelet defects, von Willebrand disease (vWD) or exposure to platelet inhibiting agents, such as Aspirin (ASA) or Aspirin-containing medication. The COL/ADP is used to indicate if an abnormal result obtained with the COL/EPI may be caused by the effect of Aspirin or medications containing Aspirin. The instrument aspirates a blood sample under constant vacuum from the sample reservoir through a capillary and microscopic aperture cut into the membrane of the test cartridge. The membrane is coated with collagen and epinephrine or ADP. The presence of these biochemical stimuli, and high shear rates generated under standardized flow conditions that simulate in vivo vascular injury, result in platelet attachment, activation and aggregation, slowly building a platelet plug at the aperture. The time required to obtain occlusion of the aperture is reported as the “closure time” (CT). The CT is indicative of the platelet function in the sample. Beginning, March 1, 2013, Avera SHH Laboratory will offer Platelet Function Analysis on the PFA-100. Meditech mnemonics for this new assay is PFA (Testing to be performed: PFA, HCT and PLT) Specimen required: 3.2% Sodium Citrate (one 4.5 mL or two 2.7 mL) and 1 Lavender EDTA Collect specimen directly into an evacuated plastic or siliconized glass tube containing 3.2% buffered sodium citrate. Draw with 21g or larger needle. Do not collect with plain syringe. Discard sample if there is a venous collapse or stoppage of blood flow during the collection. Specimen is stable at room temperature for 4 hours. The PFA-100 results will be reported as closure time in seconds (CT). Normal Reference Range: PFA/EPI 80-184 CT PFA/ADP 56-102 CT Note: If a patient has a hematocrit below 35% and/or Platelet count below 150,000, the PFA results may be affected. Expected interpretive patterns observed with the PFA-100 Normal ASA vWD Glanzmann’s Thrombasthenia COL/EPI normal abnormal abnormal abnormal COL/ADP ** normal abnormal abnormal **The COL/ADP will not be tested if the COL/EPI is normal The Bleeding Time (BT) assay procedure does not allow for the use of controls or proficiency testing to validate the quality of the procedure. The PFA testing will replace the BT currently offered for platelet function evaluation. We are removing the Bleeding Time (BT) test from our available test menu, as recommended by our accrediting agencies, CLIA and CAP. Respectfully, Doris L Heilman Automation Coordinator Avera Sacred Heart Hospital Laboratory CC: Richard Strom MD Anatomic and Clinical Pathologist Physicians Laboratory, Ltd. ASHH Laboratory Medical Director