Abstract: Objective To evaluate the performance of PENTRA MS60 hematology analyzer(PMS60) for the determination of complete blood count(CBC) and white blood cell (WBC) differential count. Methods The background count, carryover rate(CR), precisions [within-run and inter-day coefficients of variation (CV)], linear range and accuracy of PMS60 were evaluated by fresh blood samples and instrument quality control materials. The bias and correlation of PMS60 and SYSMEX XS800i hematology analyzer(XS800i) were calculated. The microscopy was as a ″gold standard″ of WBC differential count, and the accuracy of WBC differential count was calculated according to the ″gold standard″. Results The background counts of WBC, red blood cell(RBC), hemoglobin(Hb) and platelet(PLT) were all 0. The CR of WBC, RBC, Hb and PLT were 0.09%, 0.33%, 0.54% and 0.10%. The within-run CV of RBC, Hb, hematocrit(HCT), erythrocyte mean corpuscular volume(MCV), mean corpuscular hemoglobin(MCH) and mean corpuscular hemoglobin concentration(MCHC)(normal sample and medical decision level sample) were <1.5%, the within-run CV of WBC were 0.81% and 3.47%, and the within-run CV of PLT were 3.74% and 7.44%. The inter-day CV of RBC, Hb, HCT, MCV, MCH and MCHC(low, middle and high levels) were <2%, the inter-day CV of WBC were 3.47%, 2.99% and 2.49%, and the inter-day CV of PLT were 5.28%, 4.00% and 3.20%. Within the concentration range of clinical samples, the correlation coefficients(r) between the measured values and theoretical values of WBC, RBC, Hb and PLT were >0.998(P<0.01). The slope of linear regression equation was in the range of 1.00±0.05. The relative biases of Hb, HCT, MCV, MCH and MCHC were <3%, and the relative deviation of WBC, RBC and PLT were <6.5%, <3.5% and <9.5%, respectively. The coincidence rate of the relative deviation for CBC was >85%(r＞0.8, P<0.01). Compare to microscopy, the accuracy rates of WBC differential count about lymphocytes, monocytes, granulocytes, eosinophils and basophils were 95%, 95%, 85%, 80% and 75%, respectively. Conclusions The PMS60 has a good performance. It has the advantages of low carryover rate, high precision, wide linear range and reliable accuracy of the results.

Key words: Hematology analyzer, Complete blood count, Performance verification