Key result
The T-TAS device demonstrated 80% agreement (Kappa 0.695) with lumi-aggregometry for detecting severe platelet function defects like δ-SPD, but was less sensitive to milder defects.
Why the study?
Diagnosing suspected platelet function defects is challenging due to the complexity and poor standardization of screening methods.
Does the T-TAS device accurately diagnose platelet function defects compared to lumi-aggregometry in patients suspected of platelet function defects or on antiplatelet therapy?
Observational (n=122)
Does the T-TAS device accurately diagnose platelet function defects compared to lumi-aggregometry in patients suspected of platelet function defects or on antiplatelet therapy?
Effect estimate: Kappa 0.695
The T-TAS device is effective for detecting severe platelet function defects like δ-SPD, but has limited utility for milder defects or assessing response to antiplatelet therapy.
T-TAS may support point-of-care platelet testing in suspected defects; leaves open larger validation against standard aggregometry.
BACKGROUND: Patients suspected of platelet function defects represent a diagnostic challenge for the clinical laboratory, mainly due to the complexity and poor standardization of screening methods. We compared a new flow-based chip-equipped point-of-care (T-TAS) device with lumi-aggregometry and other specific tests. MATERIALS AND METHODS: The study included 96 patients suspected of platelet function defects and 26 patients referred to hospital for an evaluation of residual platelet function while on antiplatelet therapy. RESULTS: Forty-eight of 96 patients displayed abnormal platelet function by lumi-aggregometry, and 10 of them had defective granule content and were classified as δ-storage pool disease (δ-SPD). T-TAS compared favorably with lumi-aggregometry in detecting the most severe forms of platelet function defects (i.e., δ-SPD) [test agreement (lumi-light transmission aggregometry [lumi-LTA] vs T-TAS) for the δ-SPD subgroup was 80% and K CHOEN 0.695. T-TAS was less sensitive to milder platelet function defects (i.e., primary secretion defects [PSD]). Concerning patients on antiplatelets, test agreement (lumi-LTA vs T-TAS) in detecting patients who were responders to this therapy was 54%; K CHOEN 0.150. DISCUSSION: The results indicate that T-TAS can detect the more severe forms of platelet function defects such as δ-SPD. There is limited agreement of T-TAS with lumi-aggregometry in identifying responders to antiplatelets. However, this poor agreement is commonly shared by lumi-aggregometry and other devices owing to the lack of test specificity and of prospective data from clinical trials linking platelet function with therapeutic efficacy.
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Lecchi et al. (2024) conducted an observational in Suspected platelet function defects or on antiplatelet therapy (n=122). T-TAS (flow-based chip-equipped point-of-care device) vs. Lumi-aggregometry was evaluated on Test agreement for detecting δ-storage pool disease (δ-SPD) (Kappa 0.695). The T-TAS device demonstrated 80% agreement (Kappa 0.695) with lumi-aggregometry for detecting severe platelet function defects like δ-SPD, but was less sensitive to milder defects.
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