全自动化学发光免疫分析法检测梅毒抗体与TPPA的相关性

Consistency Between the Value of S/CO in Architect I2000 and TPPA in Treponema Pallidum Antibody's Measurement

目的探讨全自动化学发光免疫分析仪（Architecti2000）对梅毒螺旋体抗体检测中阳性中不同的S／CO值与确证实验（TPPA）阳性结果的一致性．从而为临床提供简便、快速及准确的检测。方法用Architect化学发光免疫分析法（ArchitectCLIA）与梅毒螺旋体凝胶试验（TPPA）同时检测439份随机标本，根据ArchitectCLIA结果的S／CO值分组，再进行统计分析。结果当S／CO范围为〈1，1～3，5～7，7—9，≥9时，TPPA阳性结果与Architecti2000的符合率分别为100％，17％，56％，88％，92％．99％。结论S／CO〈9为可疑范围，但是当S／CO≥9时，Architecti2000对梅毒螺旋体抗体检测的阳性与梅毒螺旋体明胶凝集实验（TPPA）一致程度达到99％，且Architecti2000的特异性、灵敏度均高于TPPA，抗干扰能力强，无携带污染，能满足临床要求．可作为对梅毒螺旋体抗体进行快速准确检测的初筛方法，为临床提供方便。

Objective To explore the consistency between a full automatic chemiluminescence immunoassay instrument （Architect i2000） in the value of S/CO and treponema pallidum particle agglutination （TPPA） test to offer simple, rapid and accurate clinical detection. Methods 293 samples that the S/CO for reactive syphilis was raised arbitrarily to more than 1.0 were tested by TPPA, and then analyzed the consistency. Results Syphilis TP data results were separated into S/CO （Assay signal to cut-off） groups. When the S/CO range of 1 - 3, 5 7, 7 - 9, I〉9, the consistency rate between Architect i2000 and TPPA were 17%, 56%, 88%, 92%, 99%. Conclusions An S/CO 〉1.0 is reactive by Architect i2000, a doubtful category was created for assay results with an S/CO of 1.0 - 9.0 around the area of uncertainty, but the value is raised to more than 9.0, then 99% of the reactive screen would be TPPA reactive. In addition, the system could be a reliable, sensitive, fast and easily operating method for the detection oftreponema pallidum antibody, and worth for clinic application.