Performance evaluation of the plateletworks® in the measurement of blood cell counts as compared to the beckman coulter unicel DXH 800

Abstract

Prior to undergoing cardiac surgery many patients may have impaired platelet function due to platelet inhibition. Point of care testing (POCT) that produces quick results of platelet counts and function allow earlier clinician interpretation, diagnosis and treatment. Before being adopted for routine clinical use, a POCT device's performance must be evaluated by standard laboratory techniques to ensure high quality results. The purpose of this study is to determine the performance of the Plateletworks® BC 3200 automated hematology analyzer by correlating its precision, accuracy and linearity for the measurement of blood counts to our hospital central laboratory analyzer (Beckman Coulter Unicel DXH 800). The study utilizes well described methods for Within- Run and Day-to-Day precision, comparison of methods (bias), and linearity. Control samples from the manufacturer were used for the precision studies, blood samples from 115 cardiac surgical subjects were used for comparison of methods and accuracy, and pre-diluted control samples from the manufacturer were used for the linearity studies. The precision of the Plateletworks® analyzer was acceptable. The overall coefficient of variation (CV) for the measured parameters at all levels of control for Within-Run precision was acceptable ranging from 0.65-6.4%. Likewise, the CV for the measured parameters at all levels of control for Dayto- Day precision was acceptable ranging from 1.45% to 6.7%. The correlation and accuracy between the two analyzers for the evaluated parameters (platelets, red blood cells, white blood cells, and hemoglobin) was acceptable. The linearity for the measured parameters was also acceptable with a range between 98-100%. The performance of the Plateletworks® analyzer was acceptable for providing blood cell counts as compared to our central hospital laboratory analyzer.