Hambie E A, Larsen S A, Perryman M W, Pettit D E, Mullally R L, Whittington W
J Clin Microbiol. 1983 Feb;17(2):249-54. doi: 10.1128/jcm.17.2.249-254.1983.
The rapid plasma reagin (RPR) card test manufactured by Beckman Instruments, Inc., was compared, qualitatively and quantitatively, with the Venereal Disease Research Laboratory (VDRL) slide test and the standard RPR 18-mm circle card tests for the serodiagnosis of syphilis. Sera from 638 individuals were used in this study. Two pilot lots and two production lots of antigen were submitted by Beckman Instruments, Inc., for evaluation. Qualitative agreement among the three RPR card tests was 98.1%; between the Beckman RPR card and the VDRL slide tests, 95.0%; and between the reference RPR card and the VDRL slide tests, 95.5%. The Beckman RPR card test was 95.3% specific, whereas the specificities of the reference RPR card and the VDRL slide tests were 98.8% and 96.1%, respectively. Sensitivities of the three nontreponemal tests were: Beckman RPR card test production lots, 94.7%; reference RPR card test, 96.8%; and VDRL slide test, 90.6%. Quantitative agreement +/- 1 dilution among the three RPR card tests was 93.0%, whereas quantitative agreement was approximately 40% when both RPR card tests were compared with the VDRL slide test. We found the Beckman RPR card test comparable to the standard RPR card tests. Therefore, the decision of which test to use for the serodiagnosis of syphilis is at the discretion of the user.
对贝克曼仪器公司生产的快速血浆反应素(RPR)卡片试验与性病研究实验室(VDRL)玻片试验以及标准RPR 18毫米圆形卡片试验进行了梅毒血清学诊断的定性和定量比较。本研究使用了638名个体的血清。贝克曼仪器公司提交了两批试验用抗原和两批生产用抗原进行评估。三种RPR卡片试验之间的定性一致性为98.1%;贝克曼RPR卡片与VDRL玻片试验之间为95.0%;参考RPR卡片与VDRL玻片试验之间为95.5%。贝克曼RPR卡片试验的特异性为95.3%,而参考RPR卡片和VDRL玻片试验的特异性分别为98.8%和96.1%。三种非梅毒螺旋体试验的敏感性分别为:贝克曼RPR卡片试验生产批次为94.7%;参考RPR卡片试验为96.8%;VDRL玻片试验为90.6%。三种RPR卡片试验之间定量一致性在±1个稀释度内为93.0%,而当两种RPR卡片试验与VDRL玻片试验比较时,定量一致性约为40%。我们发现贝克曼RPR卡片试验与标准RPR卡片试验相当。因此,梅毒血清学诊断使用哪种试验由用户自行决定。