[Evaluation of a new method and instrument for detection platelet aggregation function and its clinical application]

Platelet function assessment is essential for diagnosing thrombotic disorders. Prior research has shown that conventional methods for measuring platelet aggregation may lack precision or standardization. No prior work had resolved the need for a new device that could reliably detect platelet aggregation in diverse clinical settings. This gap motivated the development of new instruments that could provide consistent and reproducible results. Existing tools often fail to meet CLSI standards for variability and repeatability. That uncertainty drove the need for a more robust analytical platform. Platelet aggregation rates are known to vary with different agonists and patient conditions. This gap motivated the search for a validated method that could be applied in routine clinical practice.

The purpose of this study was to assess the performance of a new platelet function analyzer called the PL-11. The specific problem addressed is the lack of standardized and reliable tools for measuring platelet aggregation in diagnostic settings. The motivation stems from the need for a device that meets CLIA'88 and CLSI guidelines. The study aimed to establish reference intervals for the PL-11 analyzer. It also sought to evaluate the device's clinical utility in monitoring platelet function in patients with acute cerebral infarction. The researchers tested the device's ability to detect changes in platelet aggregation after clopidogrel administration. The goal was to determine whether the PL-11 could serve as a reliable diagnostic tool in thrombosis management. The study's design focused on both analytical and clinical validation.

The study used intravenous blood samples from 247 healthy volunteers and patients with acute cerebral infarction. Blood was anticoagulated with sodium citrate before analysis. Platelet aggregation was measured using the PL-11 platelet analyzer. Four agonists—PLR-06, PLR-07, PLR-09, and PLR-10—were used to induce aggregation. Reference intervals were calculated based on statistical analysis of the data. The device's performance was evaluated against CLIA'88 and CLSI guidelines. Platelet maximum aggregation rate (MAR) was the primary outcome measured. The study also assessed the change in MAR before and after clopidogrel administration in patients.

The PL-11 analyzer met all CLIA'88 and CLSI standards for performance and variability. The mean MAR for healthy volunteers was 58.8 ± 10.1% for PLR-06, 61.2 ± 11.8% for PLR-07, 51 ± 10.2% for PLR-09, and 53.1 ± 9.2% for PLR-10. Platelet MAR in ACI patients was significantly lower than in healthy controls. After clopidogrel administration, MAR increased in ACI patients. The device demonstrated consistent results across multiple agonists. The data suggest the PL-11 is reliable for detecting platelet aggregation changes. The study found no significant deviations from expected values. These findings support the use of the PL-11 in clinical settings.

The authors concluded that the PL-11 platelet analyzer is a reliable tool for measuring platelet aggregation. The device met all CLIA'88 and CLSI standards for analytical performance. The study found that the PL-11 can detect changes in platelet function after clopidogrel therapy. The device’s results were consistent across multiple agonists and patient groups. The reference intervals established in this study can guide clinical interpretation. The PL-11 is proposed as a suitable tool for diagnosing thromboembolic disease. The authors suggest that the device is suitable for early warning and monitoring in clinical settings. They propose that the PL-11 is worthy of further clinical application and distribution.