血液分析仪检测CBC分析性能验证与临床应用

目的 建立血液分析仪检测全血细胞计数（CBC）性能验证方案和实验方法.方法 依据美国临床和实验室标准化协会（CLSL）系列文件和相关文献,根据CBC检测的特点及实际工作需求,设计验证方案,对Sysmex XE2100（出厂编号A4730）检测系统CBC的5个检测指标WBC、RBC、PLT、Hb、HCT的精密度、准确度、携带污染、线性范围、生物参考区间进行验证,并根据线性范围验证结果,规定和文件化结果超出此范围时标本处理方法及报告方式.结果 检测一份新鲜血标本的5个指标,批内精密度（WBC 0.66%,RBC 0.49%,Hb 0.38%,HCT 0.77%,PLT 1.34%）均小于制造商提供的精密度范围;连续检测e-CHECK低值、中值2个浓度质控品20天,其批间精密度（WBCL1.91%、WBCM 2.14%,RBCL 0.71%、RBCM 0.44%,HbL 0.77%、HbM 0.46%,HCTL 1.05%、HCTM 0.53%,PLTL2.84%、PLTM1.49%）均小于1/3CLIA,88允许范围;检测配套校准品SCS-1000结果与靶值的相对偏倚小于〈血液分析仪校准规范化的建议〉判断标准的第一列差异;携带污染率（WBC 0.50%,RBC 0.92%,Hb0.00%,HCT 0.00%,PLT 0.52%）在制造商规定的范围内;线性范围：WBC 0.58～58.14×109、RBC 0.08～7.82×1012、Hb 2.2～220g/L、HCT 0.01～0.69、PLT 8.27～827×109;20份体检合格的健康人检测结果均在〈临床检验操作规程〉制定的范围之内.结论 出厂编号为A4730的Sysmex XE2100检测系统检测WBC、RBC、PLT、Hb、HCT的分析性能符合相关标准、文件的要求.本研究验证方法具有科学性、可行性和实用性,可为血液分析仪CBC性能验证时做参考.

Blood analyzer detecting CBC performance verification and clinical application

Objective To establish the performance verification program and experimental methods of the blood analyzer testing complete blood count （CBC）. Methods The performance program was designed according to American National Committee for Clinical and Laboratory Standards Institute （CLSI） series of documents, the characteristics of CBC testing and the needs of practical work. The precision, accuracy, carryover, lineaxity, clinical reportable biotic reference intervals were verified by the detection system of five test indicators for CBC, eg, WBC, RBC, PLT, Hb, HCT in Sysmex XE2100 （serial number A4730）. The sample disposal methods and reporting mode were established and documented by linear range of test results when the results were beyond this linear range. Results Testing the five indicators of a new collection blood sample, the within - run precision （WBG 0.66%, RBC 0.49%, Hb 0.38%, HCT 0.77%, PLT 1.34% ） were less than the manufacturer＇ s claims precision range ; Continuous detection of e - CHECK low, median 2 concentration quality control materials for 20 days, the between-run precision （WBCL1.91% ,WBCM 2.14%, RBCL 0.71% ,RBCM 0.44%, HbL 0.77%, HbM 0.46%, HCTL 1.05%, HCTM 0.53% ,PLTL2.84% ,PLTM1.49% ） were less than one - third of CLIA＇88 acceptable range. The relative bias between the supporting calibrator SCS- 1000 results and the target value were less than the number of the first column in ＂blood analyzer calibration and standardization proposal＂ criterion; Carryover（WBC 0.50% ,RBC 0.92%, Hb 0.00% ,HCT 0.00% ,PLT 0.52% ） were in the manufacturer＇s claims; Linearity ： WBC 0.58 - 58.14 × 10^9 ,RBC 0.08 - 7.82 × 10^12,Hb 2.2 - 220g/L, HCT 0.01 - 0.69,PLT 8.27 - 827 × 10^9. 20 healthy individuals＇ tests were all in the ＂Clinical Laboratory Procedures＂ set range. Conclusion The performance verification of testing the WBC, RBC, PLT, Hb, HCT in Sysmex XE2100 detection system （serial number A4730） were in line with the relevant standards and documentation requirements. This study demonstrated the methods were scientific, feasible and practical for reference to validate performance of blood analyzer testing CBC.