CAJ | 학술논문

目的研制血清C-肽的时间分辨荧光免疫分析(TRFIA)试剂盒.方法采用双抗体夹心法建立C-肽TRFIA试剂盒,并进行方法学评价.结果 C-肽可测量范围为0.4～20 ng/mL;分析敏感性为0.23 ng/mL;分析批内、批间精密度分别为7.99%、11.97%;C-肽回收率为99.57%;与胰岛素和胰岛素原无交叉反应.稳定性试验表明,试剂可以贮存在4 ℃稳定9个月,37 ℃稳定7 d;该试剂盒测试200份正常人血清样本,其参考范围为0.358～3.590 ng/mL;收集122份血清样本,用该试剂盒与国外其他方法的同类试剂盒同时检测,其相关系数为0.943 2,线性方程为Y=0.985 4X+0.506 3.结论 C-肽TRFIA试剂盒各项指标均达到临床检测要求,适合临床推广使用.
목적 연제혈청C-태적시간분변형광면역분석(TRFIA)시제합.방법 채용쌍항체협심법건립C-태TRFIA시제합,병진행방법학평개.결과 C-태가측량범위위0.4～20 ng/mL;분석민감성위0.23 ng/mL;분석비내、비간정밀도분별위7.99%、11.97%;C-태회수솔위99.57%;여이도소화이도소원무교차반응.은정성시험표명,시제가이저존재4 ℃은정9개월,37 ℃은정7 d;해시제합측시200빈정상인혈청양본,기삼고범위위0.358～3.590 ng/mL;수집122빈혈청양본,용해시제합여국외기타방법적동류시제합동시검측,기상관계수위0.943 2,선성방정위Y=0.985 4X+0.506 3.결론 C-태TRFIA시제합각항지표균체도림상검측요구,괄합림상추엄사용.
Objective To develop a time-resolved fluoroimmunoassay(TRFIA) kit for detection of C-peptide in serum. Methods Two anti-C-peptide monoclonal antibodies were used to develop the sandwich TRFIA kit for detection of C-peptide in serum and its methodology was evaluated. Results The detection range of C-peptide was 0.4-20 ng/mL.The analytical sensitivity was 0.23 ng/mL. The intra-assay and inter-assay coefficients of variation were 7.99% and 11.97% respectively. The recovery rate was 99.57%. There was no cross-reactivity with insulin and proinsulin. The TRFIA C-peptide reagents could be stored at 4 ℃ for 9 months and at 37 ℃ for 7 days. The reference value for TRFIA C-peptide kit in healthy subjects(200 cases) was 0.358-3.590 ng/mL. The correlation coefficient of blood samples detection results(122 cases) between this TRFIA kit and commercially available electrochemiluminescense immunoassay C-peptide kits was 0.943 2. The linear equation was Y=0.985 4X+0.506 3. Conclusions The developed TRFIA C-peptide kit is valuable for clinical application with good sensitivity, precision, accuracy, specificity and stability.