摘要
目的 对化学发光微粒子免疫法检测鳞状上皮细胞癌抗原（SCC Ag）进行方法学评价及性能验证。方法 对化学发光微粒子免疫法检测鳞状上皮细胞癌抗原的不精密度、回收率、线性分析、定量可报告低限值、特异性和灵敏度、反复冻融试验以及参考范围验证等方面进行评价。结果 化学发光微粒子免疫法检测鳞状上皮细胞癌抗原低、中、高值样本批内不精密度CV%分别为3.88%、2.80%和0.69%,批间不精密度CV%分别为3.98%、3.10%和3.17%;回收率为95.77%-102.25%,平均回收率为98.89%;线性分析R2为0.9997;定量可报告低限值为0.21ng/mL,CV%为15.06%;特异性为96%,灵敏度为94%;低、中、高值样本反复冻融试验CV%分别为7.99%、2.97%和1.36%;参考范围验证的检测结果均〈1.3ng/mL。结论 化学发光微粒子免疫法检测鳞状上皮细胞癌抗原方法符合实验室要求,检测性能良好,可广泛在实验室开展应用。
Objective To evaluate the chemiluminescent microparticle immunoassay for detection of squamous cell carcinoma antigen （SCC Ag ）. Methods The imprecision, recovery rate, linearity, limit of quantity, specificity and sensitivity ,repeated freezing and thawing test and the reference verification of SCC Ag were evaluated. Results The with-in run imprecision were 3.88% ,2.80% and 0.69% ,between-run imprecision were 3.98% ,3.10% and 3.17% ,respectively. The average of recovery rates was 98.89%. RE was 0. 9997 of linear analysis. The limit of quantity was 0.21ng / mL, and CV% was 15.06%. Specificity was 96% and sensitivity was 94%. The CV% were 7.99%, 2.97% and 1. 36% respectively of repeated freezing and thawing test. The result was less than 1. 3ng/mL for reference range verification. Conclusion The chemiluminescent microparticle immunoassay has a good performance in SCC Ag detection, and it meets the clinical laboratory requirements, and can be carried out in clinical laboratory widely.
出处
《标记免疫分析与临床》
CAS
2016年第10期1212-1214,共3页
Labeled Immunoassays and Clinical Medicine
基金
解放军总医院"百病妙诀"培育项目(MJ201460)
关键词
鳞状上皮细胞癌抗原
化学发光微粒子免疫法
方法学评价
Squamous cell carcinoma antigen
Chemiluminescent microparticle immune method
Methodology evaluation
