UniCel DxH 800血液分析仪的性能评价

目的：对UniCel DxH 800全自动血液分析仪的相关性能进行评价。方法：使用新鲜血标本和仪器配套质控品,评价UniCel DxH 800的精密度、携带污染率和线性范围,并观察其结果与LH750血液分析仪测定结果间的相关性;以显微镜法为＂金标准＂,评价其白细胞分类计数的准确率。制定复检规则并进行验证。结果：UniCel DxH 800测定红细胞、血红蛋白、平均红细胞体积的批内精密度均〈0.8%,测定白细胞、血小板的批内精密度均〈1.8%。上述5项参数的批间精密度均〈2.0%,携带污染率均〈0.20%。白细胞、红细胞、血红蛋白、血小板呈线性相关（r〉0.999,P〈0.01）。UniCel DxH 800与LH 750血液分析仪测定白细胞、红细胞、血红蛋白、平均红细胞体积和血小板的结果间有良好的相关性（r〉0.990,P〈0.01）。仪器分类计数与显微镜法相关性较好,其中中性粒细胞、淋巴细胞、单核细胞和嗜酸粒细胞具有很好的相关性（r值分别为0.982、0.971、0.850和0.892,P〈0.01）。对复检规则进行验证其灵敏度为90.48%,特异度为92.89%,有效性为91.78%,阳性预期值为77.03%,阴性预期值为96.52%,假阴性率为2.60%,假阳性率5.60%,复检率为24.3%。结论：UniCel DxH 800全自动血液分析仪用于全血细胞计数具有高精密度、低携带污染率和宽线性范围的优点,与LH 750全自动血液分析仪的检测结果间具有良好的相关性。复检规则适用于该仪器,假阴性率低。在各项技术参数上均能满足实验室的要求。

Performance evaluation of UniCel DxH 800 blood cell analyzer

Objective： To evaluate the performance of UniCel DxH 800 automated hematology analyzer. Methods： The precision, carryover and linearity of UniCel DxH 800 in measurement of CBC were evaluated by using fresh blood samples and instrument quality controls, and the abovementioned parameters were compared with those of LH750 blood analyzer. Results obtained by light microscopy was used as the golden criteria to assess the accuracy of leukocyte differen- tial count by UniCel DxH 800. Duplicate testing criteria was established and used for confirmation of results. Results： For intra-sample precision, the coefficient of variation （CV） for RBC, Hb and MCV were less than 0.8%, the CV for WBC and PLT were less than 1.8%. For inter-sample precision, the CV of abovementioned parameters were less than 2.0%.The car- ryover rate of WBC, RBC, Hb, MCV and PLT were less than 0.20%. In the concentration range covered by clinical sam- ples, the correlation coefficient between the measured value and the oretical value for testing WBC, RBC. Hb and PLT ex- ceeded 0.999（P〈0.01）. The measurement results for WBC, RBC, Hb, MCV and PLT by UniCel DxH 800 showed a positive correlation with those by LH 750 hematology analyzer （R2〉0.990, P〈0.01）. Correlation of parameters between UniCeI DxH 800 hematology analyzer and microscopic method was highly significant. Correlation of leukocyte differential count inclu ding granulocytes, lymphocytes, monocytes and eosinophils between UniCel DxH 800 hematology analyzer and microscopic method was highly significant （r=0.982, 0.971, 0.850, 0.892, P〈0.01）,which was better than that of LH 750. The duplicate testing criteria was validated, and the sensitivity, specificity, efficiency, positive predict value, negative predict value, false negative rate, and false positive rate were 90.48%, 92.89%, 91.78%, 77.03%, 96.52%, 2.6%, 5.6%, respectively, and the rate of duplicate testing was 24.3%. Conclusions： The UniCel DxH 800 hematology analyzer for complete blood count has the advanta