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 Diagnostics Devices, non-Annex II List A and B in conformity with the Council Directive98/79/EC. In conformity with EN15223-1:2016, EN13612:2002, EN ISO18113-1:2011, EN ISO 18113-3:2011, EN61010-2-101:2002, EN61326-2-6:2006, EN62304:2006, EN 62366:2008 and 2011/65/EU.
PC100 DISPOSABLE KIT
Eppendorf vials with reagent (1:25 for whole blood and a: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.
Validation of a new point-of-care platelet counter
Magdolna Nagy1, René van Oerle1, Sepanta Fazaeli2, John Sherry2, Peter L. A. Giesen3, Coen Lauwerijssen2, Gillian Mimnagh2, Hugo ten Cate1, Henri M. Spronk1
1Departments of Internal Medicine and Biochemistry, Cardiovascular Research Institute Maastricht, Maastricht University, Maastricht, The Netherlands
22M Engineering, Valkenswaard, The Netherlands
3 Thrombinoscope BV. Maastricht, The Netherlands
Introduction: Platelet count can be altered in various diseases and treatments and that may provide better insight into the expected outcome. So far, determination of platelet count is done within laboratory conditions by using established hematology analyzers, while a point-of-care device could be used for this purpose to speed up this process.
Aim: Our aim was to validate a newly developed point-of-care platelet counter device (PC100) by determining the bias between PC100 and a reference method (Sysmex XP-300).
Method: Whole blood was taken from 60 healthy individuals into ACDA. Platelet rich plasma (PRP) was prepared from ACDA whole blood and platelet count was adjusted to the range of 250- 3600 platelets (plts) /nL and measured with the PCI-100 and Sysmex XP-300. The PC100 platelet counter consists of a clinical analyzer and disposable glass slides, performing automatic enumeration of the platelets in two-independent adjacent chambers (chamber A, B) providing two replicates as a result.
Results: Platelet count determined in PRP by PC100 showed 1.42% median difference in comparison to the reference method. While the difference between two methods increased with concentration of platelets in PRP, a strong linear relationship remains throughout the whole interval (250- 3600 plts/nL) with high correlation coefficient (r=0.99). The slope obtained from linear regression analysis was 0.98 (95% CIs: 0.97-0.99), representing a 2% proportional difference between the two methods. Comparability assessment of the predicted bias at extreme concentrations of measuring interval, where the highest variations are expected, showed that the bias falls within the 10% acceptable range.
Discussion: The PC100 platelet counter provides equivalent results compared to the reference method, Sysmex XP-300 hematology analyzer.
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.