CA19-9时间分辨荧光免疫分析方法建立及EDTA处理血浆对其测定结果的影响

建立双抗体夹心法CA19-9时间分辨荧光免疫分析(TRFIA),探讨抗凝剂EDTA对其检测结果的影响,并对本法的稳定性和与Abbort Axsym测定结果的相关性等指标进行评价.分别按一步法和二步法对CA19-9进行测定,并比较血清标本和用EDTA处理的血浆标本对CA19-9结果的影响.结果表明本试剂盒的线性范围为0.19～600U/mL,灵敏度为0.19U/mL,批内和批间CV(%)分别为1.1%～5.4%,1.2%～5.6%.对3230份标本用本试剂盒检测与Abbort Axsym试剂盒检测结果相关系数为0.931.一步法中EDTA处理血浆标本的检测结果明显低于血清标本,二步法中两者无显著性差异.本试剂盒各项指标达到规定的要求,可用于临床血清CA19-9检测.使用中采用血清或血浆标本时要用二步法进行测定,以减少EDTA对结果的影响.

Development of TRFIA for CA19-9 and Effect of EDTA on CA19-9 Measurement

In order to detect human CA19-9 and verify the effect of EDTA on the CA19-9 assays performed by TRFIA method,TRFIA kit for human CA19-9 was developed using McAb antibody of anti-CA19-9.Blood samples were obtained from 50 inpatients and were drawn in EDTA.Samples were analyzed by CA19-9 TRFIA with one incubation and two incubation method parallelly.The results showed that CA19-9 TRFIA kit was capable of detecting CA19-9 within the range of 0.19~600U/mL with the sensitivity of 0.19U/mL.CV% of intr-and inter-assay were 1.2%~5.6% and 1.1%~5.4% respectively.The correlation coefficient of detection results between this kit and commercially available Abbort Axsym kit for 3230 blood samples was 0.931.The analysis results of CA19-9 in EDTA-treated samples are significantly lower than that in serum with one incubation method,but there was no significant difference with two incubations method.The TRFIA kit for human CA19-9 developed in this study meets the demand of clinical application.The analyses of CA19-9 by TRFIA are susceptible to the effects of EDTA in serum samples.