摘要
目的建立临床化学发光免疫检验方法学性能验证方案和实验方法。方法参考美国临床和实验室标准化协会(CLSI)系列文件和相关文献,结合工作实际,设计验证方案,并对 BayerCentaur 240化学发光免疫检测系统测定血清 AFP 的精密度、准确度、分析灵敏度、分析测量范围、临床可报告范围和生物参考区间6大分析性能进行验证和评价,并将实验结果与厂家(德国拜尔公司)提供的分析性能或公认的质量指标进行比较。结果 AFP 含量在77.4、168.0 ng/ml 时,日间不精密度分别为5.70%和4.84%,与厂商日间不精密度(4.9%和5.0%)基本一致;4个浓度校准品检测结果与靶值的相对偏倚均<5%,5份室间质评控制品检测结果与靶值的相对偏倚在-3.4%～11.9%之间;检测低限为1.04 ng/ml,略低于厂商的检测低限(1.30 ng/ml),生物检测限在2.65～3.53 ng/ml之间,功能灵敏度为3.53 ng/ml;分析测量范围为3.53～912.00 ng/ml(厂商线性范围1.3～1000.0ng/ml),临床可报告范围为3.53～182 400.00 ng/ml;生物参考区间验证结果为0.6～7.7 ng/ml(厂商参考区间<8.1 ng/ml)。结论 Bayer Centaur 240化学发光免疫检测系统检测 AFP 的分析性能符合临床要求,验证方案和实验方法简便易行。本研究对规范医学实验室建设和实验室认可,提高化学发光免疫检验质量有重要意义。
Objective To establish a method performance verification project and experimental method for the clinical chemiluminescence immunoassay. Methods Referring to CLSI evaluation protocols and pertinent literature, and by combining our actual works, we designed a verification procedure and experimental method. By Using these above, the precision, accuracy, analytical sensitivity, analytical measurement range, clinical reportable range and biotic interval of AFP on the Bayer Centaur 240 chemiluminescence immunoassay system were verificated. Results would be compared with the declaration of the manufacturer or desirable specifications derived from biologic variation. Results The results showed that the between-day inaccuracy on AFP levels at 77.4 ng/ml and 168.0 ng/ml was 5.70% and 4. 84% respectively ,these were consistent with manufacturer＇s inaccuracy claimed. The relative bias between the results measured for calibrator at four levels and target value was less 5.0%, and the relative bias between the results measured for EQA control sample at five levels and target value was - 3.4% to 11.9%. Lower limit of detection was 1.04 ng/ml, lower slightly manufacturer＇s analytical sensitivity claimed. Biologic limit of detection was 2. 65 ng/ml - 3.53 ng/ml, functional sensitivity was 3.53 ng/ml. Analytical measurement range was 3.53-912. 00 ng/ml, within manufacturer＇s liner range claimed. Clinical reportable range was 3.53-182 400. 00 ng/ml. Reference interval was 0. 6-7.7 ng/ml, within manufacturer＇ s claimed. Conclusions The main performances of the detection system are accorded with the declaration of the manufacturer. The performance verification procedure and experimental method of our research ars simple and practical, which has important significations for building medical laboratory and laboratory accreditation, improving quality of the chemiluminescence immunoassay.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2007年第11期1293-1297,共5页
Chinese Journal of Laboratory Medicine
基金
国家高技术研究发展计划资助项目(2004AA223762)
广东省医学科研基金(A2006252)
