改良稀释液用于测定超出线性范围浓度雌二醇的比较分析研究

The Comparative Analysis of Improved Diluent for the Determination ofEstradiol Concentration Beyond the Linear Range

目的改良雌二醇样本稀释液,保证准确检测超出线性范围的雌二醇样本,同时降低检测成本。方法使用化学发光免疫分析仪(Beckman DXI800,美国)及其配套试剂(Beckman Coulter,美国)进行检测,确定目标稀释浓度范围、排除稀释液本底干扰、比较不同稀释液稀释后的检测结果,确定改良型稀释液并与临床超声检测结果进行相关性分析。结果浓度范围在568~3179pg/mL时,回收率均在90%~110%之间,选择该浓度范围为稀释后样本的目标浓度区间;与S0校准品相比,小牛血清与男性混合血清1∶1(v/v)混合的稀释液,E_(2)检测均值为27pg/mL,与单纯小牛血清的65pg/mL相比,降低了稀释剂本底对样本浓度的干扰,同时又兼具经济性与容易获得性;校准品S0、小牛血清、男性混合血清、校准品S0与男性混合血清1∶1(v/v)混合稀释液以及小牛血清与男性混合血清1∶1(v/v)混合稀释液5种稀释液测定稀释后雌二醇样本的结果分别为2241±84.0pg/mL、2379±93.4pg/mL、1879±55.3pg/mL、2051±37.7pg/mL和2084±36.8pg/mL,差异分析表明,以小牛血清与男性混合血清1∶1(v/v)混合的稀释液作为改良稀释液,可以准确测定超出线性范围的高浓度雌二醇样本;该稀释液检测结果与B超评估结果相关性良好,回归方程:Y=0.8002 X+1195.1,R^(2)=0.6418,P<0.01,雌二醇检测结果与B超检查结果的符合率为70%~130%。结论使用小牛血清与男性混合血清1∶1(v/v)混合的稀释液作为改良稀释液,样本检测结果与卵巢B超检查的结果基本吻合,能够满足临床评估患者雌激素水平的需要,且有效降低了检测成本。

Objective To improve the estradiol sample diluent and reduce the detection cost while ensuring the accurate detection of estradiol samples beyond the linear range.Methods Chemiluminescence immunoanalyzer(Beckman dxi800,USA)and its supporting reagent(Beckman Coulter,USA)were used to determine the target dilution concentration range,while eliminate the background interference of diluent.We then compared the test results diluted by different diluents,and determined the improved diluent,and analyzed the correlation with the clinical ultrasonic test results.Results When the concentration range was 568-3179 pg/mL,the recoveries were 90%-110%.This concentration range was selected as the target concentration range of diluted samples;Compared with S0 calibrator,the mean value of E_(2) Detection in the diluent mixed with calf serum and male mixed serum 1∶1(v/v)was 27pg/mL.Compared with 65pg/mL of calf serum alone,it reduced the interference of diluent background on sample concentration,and was cost-effective and easy to obtain;The results of estradiol samples after dilution were 2241±84.0pg/mL,2379±93.4pg/mL,1879±55.3pg/mL,2051±37.7pg/mL and 2084±36.8pg/mL,respectively.Using the diluent of calf serum and male mixed serum 1∶1(v/v)as the improved diluent,the high concentration estradiol samples beyond the linear range could be accurately determined;The test results of the diluent had good correlation with the evaluation results of B-ultrasound.The regression equation was:Y=0.8002 X+1195.1,R^(2)=0.6418,P<0.01.The coincidence rate between estradiol test results and B-ultrasound test results was 70%-130%.Conclusion Using 1∶1(v/v)mixed diluent of calf serum and male mixed serum as the improved diluent,the sample test results are generally consistent with the results of ovarian B-ultrasound,which can meet the needs of clinical evaluation of patients’estrogen level,and effectively reduce the test cost.