Castellano G A, Madden D L, Hazzard G T, Cleghorn C S, Vails D V, Ley A C, Tzan N R, Sever J L
J Infect Dis. 1981 Apr;143(4):578-84. doi: 10.1093/infdis/143.4.578.
Three standard hemagglutination-inhibition (HAI) methods were compared with 11 commercially available diagnostic test kits for determination of immunity and serologic diagnosis of rubella using a panel of 100 sera. The three standard HAI methods involved removal of serum inhibitors with kaolin, heparin-MnCl2, or dextran sulfate-CaCl2. The HAI kaolin (Flow Laboratories, McLean, Virginia) and Rubelisa (Microbiological Associates Bioproducts, Walkersville, Maryland) kits gave the best specificity as judged by the absence of false-positive results. Rubacell (Abbott Laboratories, Chicago, Illinois), Rubindex (Ortho Diagnostics, Raritan, New Jersey), Fiax (International Diagnostic Technology, Santa Clara, California), and Rubesure (Calbiochem-Behring, La Jolla, California) gave the best sensitivity as judged by the absence of false-negative results. The kits with the highest degree of both specificity and sensitivity were HAI kaolin (Flow), HAI heparin-MnCl2 (Flow), Rubacell (Abbott), and Rubindex (Ortho). In paired sera from five patients with clinical rubella, seroconversions were shown by seven of the kits. One of the kits, Cordia R (Cordis Laboratories, Miami, Florida), showed no significant rise in antibody titer with one pair of sera. Antibody titers in the same serum varied widely between the different kits.
采用一组100份血清，将三种标准血凝抑制（HAI）方法与11种市售诊断试剂盒进行比较，以确定风疹的免疫情况和血清学诊断。三种标准HAI方法包括用高岭土、肝素 - 氯化锰或硫酸葡聚糖 - 氯化钙去除血清抑制剂。根据无假阳性结果判断，HAI高岭土试剂盒（弗洛实验室，弗吉尼亚州麦克莱恩）和Rubelisa试剂盒（微生物学联合生物制品公司，马里兰州沃克斯维尔）具有最佳特异性。根据无假阴性结果判断，Rubacell试剂盒（雅培实验室，伊利诺伊州芝加哥）、Rubindex试剂盒（奥索诊断公司, 新泽西州拉里坦）、Fiax试剂盒（国际诊断技术公司，加利福尼亚州圣克拉拉）和Rubesure试剂盒（卡尔 Biochem - 贝林公司，加利福尼亚州拉霍亚）具有最佳敏感性。特异性和敏感性程度最高的试剂盒是HAI高岭土试剂盒（弗洛）、HAI肝素 - 氯化锰试剂盒（弗洛）、Rubacell试剂盒（雅培）和Rubindex试剂盒（奥索）。在5例临床风疹患者的配对血清中，7种试剂盒显示有血清转化。其中一种试剂盒，Cordia R试剂盒（科迪斯实验室，佛罗里达州迈阿密），在一对血清中未显示抗体滴度有显著升高。不同试剂盒检测同一血清时，抗体滴度差异很大。
