PRODUCT FUNCTION
Lyophilized Platelets provides essential insights into the functional activity of von Willebrand Factor (vWF). These Platelets are designed to aid in the evaluation of von Willebrand Syndrome (vWS), supporting the diagnosis and classification of inherited or acquired vWF-related disorders.
SPECIFIC INFORMATION PROVIDED
Lyophilized Platelets are not intended for the detection of a specific disorder, condition, or risk factor. Lyophilized Platelets are essential in the assessment of von Willebrand Factor (vWF) activity and function through the vW Cofactor Assay. They are reconstituted and used to evaluate the ability of vWF to mediate platelet adhesion and aggregation, critical components of the hemostatic process. When used in conjunction with specific reagents like Ristocetin, Lyophilized Platelets facilitate the von Willebrand Factor Ristocetin Cofactor Assay (vWF), enabling the measurement of vWF’s effectiveness. TRIS Buffered Saline (TBS) in von Willebrand Factor (vWF) testing plays a crucial role by maintaining a stable pH around 7.4 and adjusting the ionic strength. This facilitates optimal interactions between vWF, Ristocetin, and platelets during the vW Cofactor Assay. TBS creates conditions that mimic physiological shear stress, crucial for assessing vWF’s ability to promote platelet adhesion and aggregation. TRIS Buffered Saline (TBS) enhances the reproducibility of assay results across different laboratories, providing reliable insights into vWF function.
AUTOMATION
Lyophilized Platelets are intended for use in semi-automated and automated Light Transmission Platelet Aggregometers. These Platelets may also be used with other turbidometric or impedance analyzers, and flow cytometers.
QUALITY / QUANTITY
There are no primary standards for Lyophilized Platelets. The responses to these Platelets are concentration dependent. A known normal donor should be tested with each new lot of Lyophilized Platelets. Standards organizations classify Ristocetin Cofactor Activity Assays as semi-quantitative or semi-qualitative.
Lyophilized Platelets come packaged as 1 x 10.0 mL vials of Lyophilized Platelets, with 1 x 10.0 mL vials of TRIS Buffered Saline (TBS) or 3 x 4.0 mL vials of Lyophilized Platelets, with 3 x 4.0 mL vials of TRIS Buffered Saline (TBS).
SPECIMEN TYPE
The test specimen is prepared from sodium citrate anti-coagulated whole blood, and the test sample is Platelet Poor Plasma (PPP). The test blank consists of Lyophilized Platelets and TRIS Buffered Saline (TBS), providing a standardized baseline for the assay.
Ristocetin Reagent may be used with human or animal Platelet Poor Plasma (PPP). Results are based on the extent and rate of platelet agglutination, reflecting the functional activity of vWF.
Reference plasmas, lyophilized formalin-fixed platelets, control plasmas, and diluents are used to perform a Ristocetin Cofactor Activity Test. Test results are determined by interpolation from a standard curve.
IN VITRO DIAGNOSTIC
Lyophilized Platelets are in vitro diagnostic reagents intended for Professional Laboratory Use Only. These Reagents are not intended for injection or ingestion.
TEST PRINCIPLE
When introduced to a 37°C Platelet Poor Plasma (PPP) test sample, the Ristocetin Reagent induces platelet agglutination by interacting with the glycoprotein Ib (GP Ib) receptor on the platelet surface, which is mediated by von Willebrand Factor (vWF). This initial aggregation, called primary aggregation, is characterized by a shape change in the platelets and is reversible. The primary aggregation may be followed by the release of endogenous ADP from platelet granules, which triggers a secondary, irreversible wave of aggregation. The extent and rate of both primary and secondary aggregation are influenced by the functional activity of vWF in the sample. The Light Transmission Platelet Aggregometer effectively captures these changes by displaying parameters such as the lag phase, shape change, and the rate and extent of aggregation over a predetermined testing period.
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