摘要
目的采用乳胶增强免疫比浊法在贝克曼库尔特AU5800全自动生化分析仪上对血清淀粉样蛋白A(SAA)进行测定,以验证其性能是否满足厂家声明和临床需求。方法依据行业标准,对项目的功能灵敏度、精密度、正确度、分析测量范围、临床可报告范围和生物参考区间进行验证评价。收集分析测量范围最大值附近标本,通过观察反应曲线找出最大吸光度(OD)值,将此OD值设为超线性报警参数并验证正确度。结果该方法检测功能灵敏度为1.00mg/L。高、低浓度质控品的批内不精密度分别为1.17%、1.27%,日间不精密度分别为3.38%、2.72%。正确度偏倚分别为-3.69%、4.38%。验证后分析测量范围为3.99~286.37mg/L,临床可报告范围为1.00~9163.84mg/L,生物参考区间为0~10mg/L。将最大反应OD值设置为1.87可以成功识别超过分析测量范围的标本。结论血清SAA测定试剂盒在AU5800生化分析仪上设置的性能满足厂家声明,并可达到预期用途要求。对标本反应区间OD值设置有助于识别钩状效应,为临床提供准确结果。
Objective To determine serum amyloid A by latex immunoturbidimetry in Beckman AU5800 automatic biochemical analyzer,so as to verify whether their performance meets the manufacturer′s declaration and clinical requirements.Methods According to the industry standards,functional sensitivity,precision,analytical measurement range,clinical reportable range and biological reference range of this project were validated and evaluated.Samples near the maximum value of linear range were collected and the maximum OD value was found by observing the response curve.The OD value was set as a superlinear alarm parameter and the correctness was verified.Results The functional sensitivity was 1.00 mg/L.The intra-batch and inter-day precision of high-level and low level quality control products was 1.17%and 1.27%respectively,and the inter-batch precision was 3.38%and 2.72%respectively.Correctness bias was-3.69%and 4.38%respectively.After verification,the analytical measurement range was 3.99-286.37 mg/L,the clinical report range was 1.00-9 163.84 mg/L,and the biological reference range was 0-10 mg/L.All of the parameters above met the requirements of the manufacturer′s instructions.Superlinear specimens could be successfully identified by setting the maximum response OD as 1.87.Conclusion The performance of the serum SAA kit set on the AU5800 biochemical analyzer meets the manufacturer′s statement and the expected use requirements.The setting of OD value in the response interval of specimens is helpful to identify the HOOK effect and provide accurate results for clinical practice.
作者
张婷
徐邦牢
ZHANG Ting;XU Banglao(Department of Clinical Laboratory,Guangzhou First People′s Hospital/the SecondAffiliated Hospital of South China University of Technology,Guangzhou,Guangdong 510180,China)
出处
《检验医学与临床》
CAS
2019年第19期2756-2760,共5页
Laboratory Medicine and Clinic
基金
国家自然科学基金青年项目(81702879)
