Background: The XPEN60 CRP&SAA (hereafter XPEN60) is a new automated hematology analyzer that can rapidly detect C-reactive protein (CRP), serum amyloid A (SAA), and blood cell counts (CBC), including the 5-part differential of white blood cells (5-DIFF). The aim of this study was to evaluate the analytical performance of XPEN60.
Methods: The analytical performance of XPEN60 was evaluated on the basis of several parameters, including the limit of blank (LoB), limit of detection (LoD), limit of quantitation (LoQ), precision, accuracy, carryover, linearity, clinical reportable range (CRR), and interference test. In addition, method comparisons between CBC and 5-DIFF, CRP, and SAA were performed on several systems.
Results: Total imprecision and accuracy for all parameters fell within acceptable criteria, and excellent measurements were observed in the dilution linearity (coefficient of determination, R2 > .99). LoBs and LoDs (0 and 0.21 mg/L for CRP, 1.1 and 2.27 mg/L for SAA) satisfy the manufacturer's statement. LoQs were 0.61 and 3.62 mg/L for CRP and SAA, respectively. No significant carryover or interference tests (<10%) were observed in this study. The comparison analysis demonstrated strong agreement between XPEN60 results and those of Sysmex-XN1000 (XN1000), except for basophils (Bas) and eosinophils (Eos). The data correlated well with E601 and Mindray CRP-M100 for CRP.
Conclusion: XPEN60 was demonstrated satisfactory analytical performance, which made it well-suited for use in clinical laboratories, emergency departments, and community hospitals.
Keywords: C-reactive protein; automated hematology analyzer; complete blood count; performance evaluation; serum amyloid A.
© 2020 The Authors. Journal of Clinical Laboratory Analysis Published by Wiley Periodicals LLC.