Kim Yeong Sic, Lee Jehoon, Lee Hae Kyung, Kim Hyunjung, Kwon Hi Jeong, Min Ki Ouk, Seo Eun Joo, Kim Soo-Young
Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Korean J Lab Med. 2009 Aug;29(4):331-7. doi: 10.3343/kjlm.2009.29.4.331.
We compared two automated Rapid Plasma Reagin (RPR) assay kits with a manual RPR assay kit to evaluate the possibility of using the two automated RPR assays as an alternative to the manual RPR assay for a quantitative monitoring.
One hundred eighty-five samples were analyzed, including 16 sera from patients with primary, secondary, and latent syphilis. Measured RPR unit (R.U.) values of two automated RPR assay kits, Mediace RPR (Sekisui Chemical Co., Ltd, Japan) and HBi Auto RPR (HBI Co., Ltd, Korea), were compared with the RPR titers of Macro-Vue RPR card test (Becton Dickinson BD Microbiology systems, USA). As a confirmatory test, Anti-Treponema pallidum EUROLINE WB (IgG) and Anti-Treponema pallidum EUROLINE WB (IgM) (Euroimmun, Germany) were used.
There was a prozone effect with Mediace RPR at RPR titer (card test) of 1:16, but not with HBi Auto RPR. The R.U. values of the two automated RPR assays did not show proportional increase to the RPR titer. Agreement between manual RPR and two automated RPR assay kits, Mediace RPR assay and HBi Auto RPR assay, were 83.8% and 83.2%, respectively.
The two automated RPR assay kits could not be used as an alternative to manual RPR test for quantitative analysis of RPR titer. As Mediace RPR shows a prozone effect at relatively low RPR titer, caution is needed in the interpretation of the measured values.
我们将两种自动化快速血浆反应素(RPR)检测试剂盒与一种手动RPR检测试剂盒进行比较,以评估使用这两种自动化RPR检测作为手动RPR检测的替代方法进行定量监测的可能性。
分析了185份样本,包括16份来自一期、二期和潜伏梅毒患者的血清。将两种自动化RPR检测试剂盒,即日本积水化学株式会社的Mediace RPR和韩国HBI株式会社的HBi Auto RPR的测量RPR单位(R.U.)值与美国BD微生物系统公司的Macro-Vue RPR卡试验的RPR滴度进行比较。作为确证试验,使用了德国欧蒙公司的抗梅毒螺旋体EUROLINE WB(IgG)和抗梅毒螺旋体EUROLINE WB(IgM)。
Mediace RPR在RPR滴度(卡试验)为1:16时出现前带效应,但HBi Auto RPR未出现。两种自动化RPR检测的R.U.值与RPR滴度未呈现出成比例的增加。手动RPR与两种自动化RPR检测试剂盒,即Mediace RPR检测和HBi Auto RPR检测之间的一致性分别为83.8%和83.2%。
两种自动化RPR检测试剂盒不能替代手动RPR检测用于RPR滴度的定量分析。由于Mediace RPR在相对较低RPR滴度时显示出前带效应,在解释测量值时需要谨慎。