抗环瓜氨酸肽抗体检测试剂盒方法学评价

摘要

目的：速率散射比浊法测定抗环瓜氨酸肽抗体检测试剂盒的方法学评价。方法：对试剂盒的回收率、精密度、批间差、线性、特异性等进行验证。结果：抗环瓜氨酸肽抗体检测试剂盒的批内精密度为6%(低值)、4%(高值)，批间精密度为7%(低值)、6%(高值)，回收率为92%(低值)、104%(高值)，线性范围为0.2~9 mg/ml，线性方程为Y=1.0179X-0.0346，R2=0.9960，抗干扰性强，血红蛋白≤5 g/L、甘油三酯≤5 mmol/L、胆红素≤97μmol/L对测定无影响。结论：抗环瓜氨酸肽抗体检测试剂盒检测样本快速、准确、可靠，适用于诊断。%Objective:To evaluate the performance of anti-cyclic cirullinated peptide antibodies kit system with rate nephelometry.Method:The within-run and between-run percisions,linerity,correlation and reference range of anti-cyclic cirullinated peptide antibodies kit system was verified.Result:The within-run precision were 6%(low value),4%(high value),and the between-run precision were 7%(low value),6%(high value),the recovery were 92%(low value),104%(high value).The linearity range was 0.2-9 mg/ml,and the correlation equation wasY=1.0179X-0.0346,R2=0.9960.Hemoglobin,triglyceride and bilirubin had rarely interfere.Conclusion:The method is single,rapid,stable,sensitive and accurate.It has the ability to anti-interference of hemoglobin, triglyceride and bilirubin.It can be used in the routine determination of anti-cycliccirullinated peptide antibodies.