目的 观察痰热清注射液对9种肿瘤标志物电化学发光法、光激化学发光法检测结果的干扰情况.方法 收集近期未使用痰热清注射液的肿瘤科患者和健康人新鲜血清混合制备基础样本,将40 μL痰热清注射液(浓度为40 mL/L)和注射用水分别加入960 μL基础样本中,分别配制成干扰样本和对照样本.采用干扰筛选试验观察痰热清注射液对9种肿瘤标志物[甲胎蛋白(AFP)、癌胚抗原(CEA)、糖类抗原125(CA125)、糖类抗原15-3(CA15-3)、糖类抗原19-9(CA19-9)、糖类抗原72-4(CA72-4)、非小细胞肺癌相关抗原21-1(CYFRA21-1)、总前列腺特异性抗原(TPSA)、游离前列腺特异性抗原(FPSA)]电化学发光法、光激化学发光法的检测结果干扰情况,采用剂量效应试验测算痰热清注射液的干扰效应及最低干扰浓度.结果 痰热清注射液对CA19-9的电化学发光法检测结果存在负干扰,对AFP、CEA、CA125、CA15-3、CA72-4、TPSA、FPSA、CYFRA21-1等8种肿瘤标志物的电化学发光法检测结果均无干扰.痰热清注射液对9种肿瘤标志物的光激化学发光法检测结果均无干扰.当药物浓度为40 mL/L时,痰热清注射液对电化学发光法检测CA19-9的干扰效应为-29.28%.建立的干扰剂量效应拟合方程为:Y=-0.7231X-1.938,痰热清注射液对电化学发光法检测CA19-9产生干扰的最低干扰浓度为8.84 mL/L.结论 痰热清注射液对CA19-9的电化学发光法检测结果存在负干扰,干扰效应为-29.28%,最低干扰浓度为8.84 mL/L.
Objective To observe the interference of Tanreqing injection on the detection results of nine tumor mark-ers using electrochemiluminescence assay and light-initiated chemiluminescence assay.Methods We collected the fresh serum from oncology patients who did not use Tanreqing injection and healthy individuals to prepare the basic sam-ple;40 μL Tanreqing injection(concentration of 40 mL/L)and injection water were added to 960 μL basic samples and were taken as the interference samples and control samples,respectively.Results Tanreqing injection had negative in-terference with the electrochemiluminescence assay detection of CA19-9,and had no interference with the electrochemilu-minescence assay detection of 8 tumor markers such as AFP,CEA,CA125,CA15-3,CA72-4,TPSA,FPSA,CYFRA21-1.Tanreqing injection showed no interference on the results of the light-initiated chemiluminescence assay detection of 9 tu-mor markers.When the drug concentration was 40 mL/L,the interference effect of Tanreqing injection on the detection of CA19-9 by electrochemiluminescence assay was-29.28%.The established interference dose effect fitting equation was Y=-0.7231X-1.938,and the minimum interference concentration of Tanreqing injection on the detection of CA19-9 by electrochemiluminescence assay was 8.84 mL/L.The interference screening test was used to observe the interference of Tanreqing injection on the detection results of 9 tumor markers[alpha fetoprotein(AFP),carcinoembryonic antigen(CEA),carbohydrate antigen 125(CA125),carbohydrate antigen 15-3(CA15-3),carbohydrate antigen 19-9(CA19-9),carbohydrate antigen 72-4(CA72-4),non-small-cell lung cancer-associated antigen 21-1(CYFRA21-1),total pros-tate-specific antigen(TPSA),and free prostate-specific antigen(FPSA)]using electrochemiluminescence assay and light initiated chemiluminescence assay.The dose response test was used to calculate the interference effect and minimum inter-ference concentration of Tanreqing injection.Conclusions Tanreqing injection has negative interference on the electro-chemiluminescence detection of CA19-9,with an interference effect of-29.28%and a minimum interference concentra-tion of 8.84 mL/L.