4种胶乳免疫比浊法淀粉样蛋白A试剂检测性能及结果一致性评价  

The Performance Verification and Consistency Evaluation of Four Amyloid A Immunoturbidimetry Reagents

作　　者：王丹晨 夏良裕[1] 侯立安[1] 国秀芝[1] 李洪雷[1] 张颖[1] 刘欣[1] 刘荔[1] 苏玉君[1] 梁小悦 王亚静[1] WANG Danchen;XIA Liangyu;HOU Li’an;GUO Xiuzhi;LI Honglei;ZHANG Ying;LIU Xin;LIU Li;SU Yujun;LIANG Xiaoyue;WANG Yajing(Department of Laboratory Medicine,Peking Union Medical College Hospital,Beijing,100730,China)

机构地区：[1]中国医学科学院,北京协和医学院,北京协和医院检验科,北京100730

出　　处：《标记免疫分析与临床》2024年第6期1151-1156,共6页Labeled Immunoassays and Clinical Medicine

基　　金：北京市临床重点专科医学检验科卓越项目(编号:2K201000)。

摘　　要：目的评估4种淀粉样蛋白A(SAA)试剂分析性能和结果一致性。方法性能评价。收集临床检测剩余样本,参考CLSI相关文件,评估4种淀粉样蛋白A试剂的精密度、线性、稀释验证、干扰、携带污染及参考区间,并对4种试剂(分别标记A~D)进行方法学比对及偏移评估。结果A、B、C、D4种试剂检测SAA的重复性和实验室内不精密度均<4%。在声称的分析测量范围内均呈线性(R^(2)>0.99)。4种试剂的稀释回收率为90.0%~103.1%、90.3%~138.1%、116.9%~131.2%、97.5%~102.0%。检测20例表观健康人,每种试剂均有18例(90%)检测结果在制造商提供的参考区间内。共纳入47临床样本进行比对,与4种试剂检测结果的均值相比,分别有11例(23.4%)、13例(27.7%)、3例(6.4%)、6例(12.8%)偏差超过±15%。样本中游离胆红素≤364.8μmol/L、结合胆红素≤327.7μmol/L、血红蛋白≤4.98g/L、乳糜≤1599.2 FTU时,百分偏差均在±10%以内。结论本研究评估的4种胶乳免疫比浊法SAA试剂在全自动生化分析上检测的精密度、线性、抗干扰能力均符合制造商声称要求,但部分试剂稀释回收性能不符合要求,不同试剂检测临床样本结果一致性有待提高,临床实验室在选用前应严格评估。Objective To evaluate the performance and consistency among four Amyloid A(SAA)reagents.Methods After clinical testing,the residual serum samples were collected and tested for precision,linearity,interference,and reference interval using the CLSI guidelines.Four types of SAA reagents were used and labeled as A to D.Results The four reagents(A-D)were found to have a repeatability and in-laboratory imprecision of less than 4%.The results were all linear within the claimed analytical measurement range,with R^(2) of greater than 0.99.The dilution recovery of the four reagents were as follows:90.0%-103.1%,90.3%-138.1%,116.9%-131.2%,and 97.5%-102.0%,respectively.Twenty healthy individuals were tested,and 18(90%)of each reagent had test results within the reference range provided by the manufacturer.A total of 47 clinical samples were compared with the mean of the test results of the four reagents.The results showed as follows for four reagents:11 cases(23.4%),13 cases(27.7%),3 cases(6.4%),and 6 cases(12.8%)were biased by more than±15%,respectively.The percentage deviation of free bilirubin≤364.8μmol/L,conjugated bilirubin≤327.7μmol/L,hemoglobin≤4.98g/L,and chyle≤1599.2 FTU were all within±10%.Conclusion The four immunoturbidimetric SAA reagents tested on an automatic biochemical analyzer can meet manufacturer’s claims for precision,linearity,and anti-interference.However,some reagents did not meet the requirements for dilution and recovery.The consistency of clinical sample results among different reagents needs further improvements.Therefore,clinical laboratories should conduct more strict evaluations before selecting these reagents.

关 键 词：淀粉样蛋白A 病毒 方法学比对 感染 评价研究 

分 类 号：R-331[医药卫生]