未成熟粒细胞检测的评估及参考范围的建立

目的探讨血液分析仪定量检测不成熟粒细胞（IG）指数的临床应用;建立本实验室应用Sysmex XE-2100全自动血液分析仪进行IG检测的正常参考值范围。方法应用临床标本连续测定20次,观察其批内精密度;用2个水平质控物连续测定20 d,观察其批间精密度;分别应用血液分析仪和流式细胞仪对101例标本进行IG指数测定,对其结果进行相关性回归分析和一致性比较;对883例全血标本分别用血液分析仪进行自动幼稚粒细胞计数和手工推片染色后显微镜检分类,比较血液分析仪检测与显微镜镜检的一致性;以Sysmex XE-2100全自动血液分析仪和配套试剂盒测定766名健康者的IG值,以确立本室检测的参考范围。结果高、中、低值检测的批内精密度结果IG绝对计数的CV值分别为4.78%、5.35%、13.06%,IG百分率的CV值分别为3.82%、6.03%、14.54%;批间精密度2个水平的CV值分别为IG绝对值4.38%、5.13%;IG百分率4.3%、5.1%,均〈15%,在允许范围内。与流式细胞法比较具有良好相关性,相关系数（r）为0.916;与人工镜检比较的r为0.8903;年龄间比较各年龄组IG值间P均〉0.05,即年龄间差异无统计学意义;性别间比较P〈0.05,即性别间差异有统计学意义,分性别不分年龄建立本室IG检测的参考值范围为IG绝对值95%可信区间男（0,0.04×10^9/L）;女（0,0.02×10^9/L）。IG百分率95%可信区间男（0,0.5%）;女（0,0.4%）。结论临床应用血液分析仪定量检测IG方法可行,能为临床疾病的诊断和治疗监测提供实验室数据。各实验室应建立本实验室检测的参考值范围。

Evaluation of immature granulocyte determination and establishment of its reference range

Objective To investigate the immature granulocyte (IG) count determination by the automated hematology analyzer in clinical application and establish a normal reference range of IG of our laboratory by Sysmex XE-2100 automated hematology analyzer. Methods A clinical sample was determined successively for 20 times to ensure the intra-batch precision; 2 quality controls were determined successively for 20 days to ensure the inter-batch precision. The IG counts of 101 specimens were determined by the Sysmex XE-2100 hematology analyzer and flow cytometry respectively,and the results were compared to evaluate the correlation. 883 whole blood specimens were determined and classified by the Sysmex XE-2100 hematology analyzer and manual microscopy respectively,and the results were compared to evaluate the consistency. 766 healthy subjects were determined by the Sysmex XE-2100 automated hematology analyzer for determining the IG count and establishing the reference range. Results The intra-batch coefficients of variation (CV) of absolute IG counts of high, medium and low precision values were 4.78%,5.35% and 13.06% respectively. The intra-batch CVs of IG% were 3.82%,6.03% and 14.54% respectively. The inter-batch CVs of absolute IG counts of high and low values were 4.38% and 5.13% respectively. The inter-batch CVs of IG% were 4.3% and 5.1% respectively. All of them were within the tolerance limit (<15%). The correlation coefficient (r) between Sysmex XE-2100 hematology analyzer and flow cytometry was 0.916, and that between Sysmex XE-2100 hematology analyzer and manual microscopy was 0.890 3. There was no significant difference between different ages (P>0.05),but not between male and female (P<0.05). IG reference ranges were established regardless of age. The absolute IG count reference range for male was (0,0.04×10~9/L), and for female it was (0, 0.02×10~9/L). The IG% reference range for male was (0,0.5%), and for female it was (0,0.4%). Conclusions Hematology analyzer can be used for IG count and provide data for diagnosis and therapy monitoring. Every clinical laboratory should establish its own reference range of IG count.