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PC100 PLATELET COUNTER Validation & CERTIFICATION

VALIDATION OF THE PC100 PLATELET COUNTER

PC100 Platelet Counter validation is performed for human whole blood and PRP measurements. The validation ranges for whole blood are [20-600] and for PRP [250-3600] plt/nl.

The performance validation was performed by Maastricht UMC+, Clinical Thrombosis & Hemostasis Department in the Netherlands.

Counting results of the PC100 platelet counter

Comparison of the PC100 against the SYSMEX XP-300 and Sysmex XN-9000

In a study published in May 2021 in ‘Thrombosis Journal’ the closeness of agreement between a newly developed point-of-care PC100 platelet counter and two reference methods (Sysmex® XP-300, Sysmex® XN-9000) in measuring platelet counts in whole blood and platelet-rich-plasma (PRP) was assessed. Using blood of 119 individuals of which 74 were used to prepare PRP samples.

Results

Results show a median difference of − 1.35% and − 2.98% occurred in whole blood platelet count between the PC100 platelet counter and the Sysmex® XP-300 and Sysmex® XN-9000, respectively. A strong linear correlation (r ≥ 0.98) was seen in both cases and regression equations indicated neither a constant nor a proportional bias between the methods. Direct comparison of the two reference methods revealed a median difference of − 1.15% and a strongly linear relationship (r = 0.99). Platelet count in PRP resulted in a median difference of 1.42% between the PC100 platelet counter and the reference method, Sysmex® XP-300. While the difference between two methods increased with concentration of platelets in PRP, a strong linear relationship remained throughout the whole measuring interval indicated by the high correlation coefficient (r = 0.99). Assessment of the predicted bias at predefined platelet counts showed that the bias in platelet counts falls within the acceptance criterion for both whole blood and PRP measurements.

Conclusions

Our results show that the PC100 platelet counter can be used interchangeably with the reference methods for determining platelet counts.

Ce-MARKING of the PC100 platelet counter

The PC100 Platelet Counter is a device intended by the manufacturer to be used in vitro for the examination of blood derived from the human body, and matches the definition of ‘in vitro diagnostic medical device’, falling within the scope of IVD Regulation 2017/746. The PC100 is CE-marked and complies with IVD guidelines and regulations.

In Vitro Diagnostic Device class A, in conformity with the IVD Regulation 2017/746. In conformity with EN 15223-1:2016, EN ISO 20417:2021, EN ISO 18113-1:2011, EN ISO 18113-3:2011, EN 13612:2002, EN 61010-2-101:2017, EN 61326-2-6:2013, EN 62304:2006 + A1:2015, EN 62366-1:2015 + A1:2020 and RoHS Directive 2011/65/EU.

To ensure full system quality, the PC100 Platelet Counter has been manufactured by Dutch Medical Devices BV in compliance with the requirements of applicable regulatory standards. DMD has a Quality Management System according to ISO 13485:2016.