PC100™ PLATELET COUNTER
The PC100 Platelet Counter is a highly portable point-of-care device that accurately counts cells (platelets / thrombocytes) in minutes.
The automatic cell counter for thrombocytes or platelets is able to accurately count platelet concentrations in whole blood as well as in Platelet Rich Plasma (PRP). The platelet counter is a device which removes the need to count thrombocytes manually and is a cost effective, small and a flexible alternative to flowcytometers. The measurement principle is based on patented optical imaging technology. All parts that come into contact with blood are disposable – no contamination, no cleaning time. The total blood sample preparation and automatic counting is typically done within 15 minutes.
Full platelet count including blood sample preparation within 15 minutes.
Highly accurate and reproducible from 20μl of blood or 10μl of PRP. Medically validated by Maastricht University Hospital.
EASY TO OPERATE
The device uses disposable counting slides making it is fast, clean and accurate.
COUNTS LOW TO HIGH
It counts platelets in whole blood within the range [20-600] platelets per nl and [250-3600] in PRP.
SPECIFICATIONS of the PC100 Platelet Counter
MEDICAL IVD DEVICE
In Vitro Diagnostic Device class A, in conformity with the IVD Regulation 2017/746. In conformity with EN 15223-1:2021, 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.
Eppendorf vials with reagent (1:25 for whole blood and 1:100 for PRP) & disposable counting slides.
Results comparable to flow cytometry (gold standard) & manual count.
The PC100 software runs on Windows 10 (x64) machines with free USB3 and USB2 ports (i7, 8GB RAM, 250GB SSD recommended).
Complete blood sample preparation & platelet count typically within 15 minutes.
Easy to operate software. Single click measurements. Advanced research mode for more measurement details.
Evaluation of the analytical performance of the PC100 platelet counter
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 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.
Dutch Medical Devices B.V.
John F Kennedylaan 3,
5555 XC, Valkenswaard,
Phone: +31 40 298 2020