AVE-764B尿液有形成分分析仪的性能评价及临床应用价值

目的对AVE-764B尿液有形成分分析仪的性能进行评价,评估其是否能用于尿液有形成分检测。方法对仪器的精密度、分析测量范围、携带污染、阳性检出符合率、干扰试验及315份临床尿液标本红细胞、白细胞参数与人工镜检法结果比对,对五大性能指标进行验证和评价。结果仪器的批内精密度高、中、低值分别为6.93%、8.95%、12.33%;批间精密度高、中、低值分别为7.64%、9.72%、12.48%;红细胞在(0～18 812)个/微升线性范围相关系数(r)为0.987,白细胞在(0～2 020)个/微升线性范围r为0.972;红细胞、白细胞阳性检出符合率分别为100%、90%;红细胞、白细胞携带污染率分别为0.06%、0.01%;干扰试验:草酸钙结晶不干扰仪器红细胞的检测结果;315份临床尿液标本采用Kappa一致性检验进行仪器与人工镜检法结果比较,红细胞:U=8.95,P<0.05;白细胞:U=41.49,P<0.05,显示两种检测方法结果一致。但在本研究的315例尿液标本中,AVE-764B尿液有形成分分析仪对环形红细胞容易漏检,经厂家技术人员多次调整参数后,又对54例镜下血尿标本用上述两种方法进行检测比较,红细胞:U=5.09,P<0.05,两种检测方法具有一定的一致性。结论 AVE-764B尿液有形成分分析仪可用于尿液有形成分检测,但必须把仪器的参数调节在最佳状态,使用前用含环形红细胞的血尿标本进行验证,确保仪器能拍摄到环形红细胞,以免漏检环形红细胞,并定期验证,以避免计数池变脏而漏检。

Performance evaluation and clinical application of AVE-764B urine formed elements analyzer

Objective To evaluate the performance and clinical application of the AVE-764B urine formed ele- ments analyzer,and to assess whether it can be used to detect urine formed elements. Methods The measurement of precision,analytical measurement range, contamination, positive coincidence rate, and interference test were evaluated by the AVE-764B. A total of 315 urine samples underwent the measurement of red blood cells（RBC） and white blood cells（WBC） using AVE-764B and subsequent manual microscopic examination,and their results were verified and as- sessed. Results The high,medium,low values of the intra-assay precision and the inter-assay precision of the instru- ment were 6. 93% ,8.95%,12.33% and 7.64%, 9.72%, 12.48% respectively; the correlation coefficient of RBC is 0. 987 within 0-18 812/μL. The correlation coefficient of WBC is 0. 972 within 0-2 020/μL. The positive consistent rates of RBC and WBC were 100% and 90% respectively. The contamination rates of RBC and WBC were 0. 06% and 0.01% respectively. The crystallization of calcium oxalate did not interfere the detection of RBC as shown in the in- terference test. The RBC and WBC results of 315 urine samples between AVE-764B and microscopic examination were compared by Kappa consistency test and the result indicated that this two measurement methods were consistent （U= 8.95,P〈0.05 and U= 41.49,P〈0.05 respectively）. However,we found that annular red blood cells were easily omitted in the AVE-764B analyzer in 315 cases of urine specimens. After several times parameter adjustment, we compared these two methods by testing other 54 microscopic hematuria cases,and the results suggested that these two measurement methods have some consistency（red blood cell：U= 5.09,P〈0.05）. Conclusion The AVE-764B is suitable for analysis of urine formed elements, but the parameters of the analyzer must be adjusted to the best con- dition. Before the application of AVE-764B,hematuria specimens containing annular red blood cells must be validated to ensure that the equipment can screen annular red blood cells. Thus it can avoid the omission of annular red blood cells,also the analyzer should be verified regularly to avoid the omission due to dirty counting chambers.