Huh Hee Jin, Lee Kyo Kwan, Kim Eu Suk, Chae Seok-Lae
Department of Laboratory Medicine, College of Medicine, Dongguk University, Gyeonggi Province, Korea.
Korean J Lab Med. 2007 Oct;27(5):324-9. doi: 10.3343/kjlm.2007.27.5.324.
We compared the results of automated and quantitative methods for the diagnosis of syphilis, Mediace Rapid Plasma Reagin (RPR) and Mediace Treponema pallidum Latex Agglutination (TPLA) (Sekisui Chemical Co., Ltd, Japan) with those of conventional methods.
Sera from 3,896 persons who had health checkups between December 2005 and November 2006 were included in the evaluation of positive rates and biological false positives (BFP) for Mediace RPR and TPLA. In addition, 134 patients' sera positive for automated Mediace RPR or TPLA were tested for VDRL and TPHA. Discrepancies between TPLA and TPHA results were confirmed by the RecomBlot Treponemal IgG/IgM (Mikrogen GmbH, Germany). Automated Mediace RPR and TPLA were performed using the Hitachi 7600 chemistry autoanalyzer (Hitachi, Japan). Samples with positive Mediace RPR and negative TPLA results were defined as BFP.
Positive rate of automated Mediace RPR was 0.23% (9/3,896). BFP of the Mediace RPR was 0.18%. Positive rate of automated TPLA was 1.62% (37/2,284). Among the 134 patients' sera, 33 (24.6%) showed a discrepancy between conventional VDRL and automated Mediace RPR results: Among 31 Mediace RPR(+)/VDRL(-) sera, 13 were positive and 18 were negative for TPLA. The remaining 2 sera of discrepancy with Mediace RPR(-)/VDRL(+) were all positive for TPLA. There were seven sera that showed a discrepancy between automated TPLA and TPHA results: Two sera with Mediace RPR(+)/TPLA(-)/TPHA(+) showed negative recomBlot Treponemal IgG/IgM results, and among five sera with TPLA(+)/TPHA(-), three demonstrated IgG or IgM by recomBlot Treponemal IgG/IgM.
The results of comparison data demonstrated that automated TPLA results had a high concordance with recomBlot Treponemal IgG/IgM results. Moreover, there are additional advantages of automated methods such as quantitative detection, low infection risk, and no influence by human handling.
我们将梅毒诊断的自动化定量方法（日本积水化学株式会社的梅毒快速血浆反应素（RPR）和梅毒螺旋体乳胶凝集试验（TPLA））与传统方法的结果进行了比较。
纳入了2005年12月至2006年11月期间进行健康检查的3896人的血清，以评估梅毒快速血浆反应素和梅毒螺旋体乳胶凝集试验的阳性率及生物学假阳性（BFP）。此外，对134例梅毒快速血浆反应素或梅毒螺旋体乳胶凝集试验自动化检测呈阳性的患者血清进行了性病研究实验室试验（VDRL）和梅毒螺旋体血凝试验（TPHA）检测。梅毒螺旋体乳胶凝集试验和梅毒螺旋体血凝试验结果之间的差异通过重组印迹梅毒螺旋体IgG/IgM（德国米高真有限公司）进行确认。梅毒快速血浆反应素和梅毒螺旋体乳胶凝集试验自动化检测使用日立7600化学自动分析仪（日本日立公司）。梅毒快速血浆反应素呈阳性而梅毒螺旋体乳胶凝集试验结果为阴性的样本被定义为生物学假阳性。
梅毒快速血浆反应素自动化检测的阳性率为0.23%（9/3896）。梅毒快速血浆反应素的生物学假阳性率为0.18%。梅毒螺旋体乳胶凝集试验自动化检测的阳性率为1.62%（37/2284）。在134例患者血清中，33例（24.6%）显示传统性病研究实验室试验和梅毒快速血浆反应素自动化检测结果之间存在差异：在31例梅毒快速血浆反应素（+）/性病研究实验室试验（-）血清中，13例梅毒螺旋体乳胶凝集试验呈阳性，18例呈阴性。与梅毒快速血浆反应素（-）/性病研究实验室试验（+）存在差异的其余2例血清梅毒螺旋体乳胶凝集试验均为阳性。有7例血清显示梅毒螺旋体乳胶凝集试验自动化检测和梅毒螺旋体血凝试验结果之间存在差异：2例梅毒快速血浆反应素（+）/梅毒螺旋体乳胶凝集试验（-）/梅毒螺旋体血凝试验（+）血清重组印迹梅毒螺旋体IgG/IgM结果为阴性，在5例梅毒螺旋体乳胶凝集试验（+）/梅毒螺旋体血凝试验（-）血清中，3例通过重组印迹梅毒螺旋体IgG/IgM检测出IgG或IgM。
比较数据结果表明，梅毒螺旋体乳胶凝集试验自动化检测结果与重组印迹梅毒螺旋体IgG/IgM结果高度一致。此外，自动化方法还有其他优点，如定量检测、感染风险低且不受人工操作影响。
