化学发光免疫测定在梅毒螺旋体抗体检测中的临床应用

摘要

Objective To explore the clinical application of a full automatic chemiluminescence immunoassay instrument system for the detection of treponema pallidum antibody. Methods The precision, sensitivity,anti interference and carry over of ARCHI TECT I2000 system were analyzed. 50 TPsAb negative and 307 TPsAb positive samples, detected on ARCHITECT 12000, were an alyzed by Toluidine red unhmated serum regain test(TRUST) and Treponema pallidum particle agglutination test(TPPA) separate ly. Results The within run and between run coefficients of variation(CV) of ARCHITECT I2000 were both less than 10％. The treponema pallidum antibody could be detected by the TPsAb in 1: 16 dilutions and TPPA in 1: 8 dilutions of positive standards.The carry over rate of ARCHITECT 12000 was 0.13 ％. The affects of triacylglycerol with 30.0 mmol/L, hemoglobin with 120.0 g/L and biliubin with 320.0 mol/L were all less than 4％. There was no significant difference between TPsAb and TPPA(P＞ 0.05). Conclusion The system could be a reliable,sensitive,fast and easily operating method for the detection of treponema palli dum antibody,and worth for clinic application.%目的 探讨全自动化学发光免疫分析仪在梅毒螺旋体特异性抗体(TPsAb)检测中的临床应用价值.方法 验证ARCHITECT I2000全自动化学发光免疫分析仪在TPsAb检测中的精密度、灵敏度、抗干扰能力及携带污染.对50例化学发光免疫测定TPsAb阴性及307例TPsAb阳性临床标本分别进行梅毒螺旋体抗体明胶颗粒凝集试验(TPPA)和甲苯胺红不加热血清试验(TRUST)检测.结果 ARCHITECT I2000系统批内、批间变异系数均小于10%.高值标准品稀释后用TPsAb和TPPA同时检测,TPsAb检测1∶16稀释标本为阴性,TPPA检测1∶8稀释标本为阴性.ARCHITECT I2000系统的携带污染率为0.13%.30.0 mmol/L三酰甘油、120.0 g/L血红蛋白、320.0 mol/L胆红素对测定结果的响影小于4%.TPsAb与TPPA检测临床标本阳性率差异无统计学意义(P>0.05).结论 全自动化学发光免疫分析仪检测TPsAb,其精密度较好,特异性强,灵敏度高于TPPA,抗干扰能力强,无携带污染,值得在临床推广.