Massonnet-Castel S, Simonneau M, Jaulmes B
Rev Fr Transfus Immunohematol. 1984 Feb;27(1):77-89. doi: 10.1016/s0338-4535(84)80008-2.
We tested a new radiometric assay (Hépatube Wellcome) using a complete automatic device, in hepatitis B surface antigen detection with I 125 marked antibody. The additional advantage of this reagent is its very long life-span (twelve weeks after the date of manufacture). The hepatube system is fully automatic, micro processor-controlled and designed to complete all washing and tracer addition steps in the hepatube test sequence after addition of the patient's sample. The results were compared in the same protocol with those obtained by the method currently used in our group (Ausria II 125). This study has been carried out on 7.589 sera or plasma samples; blood donors 5.352; medical and chirurgical patients 1.292; sera panel 87; repeated tests 367; positives and negatives control sera 421; assays ran the first day 70 The 153 positive results (2.3%) were confirmed by another assay before neutralisation. The sensitivity of both techniques was compared using a reference panel containing samples showing varying degrees of positivity, and representative of both main subtypes. We repeated the assay on this panel 2 months after issue of materials and again 3 months later. This new system is more sensitive than Ausria II 125. Of 6 644 patients the false positive was found in 1,1% of the cases, this was superior to the results found with Ausria II 125 but there is no false negative with this new method. There was no difference when serum or plasma was used.
我们使用一台全自动设备测试了一种新的放射免疫分析方法(肝管威康法),用于检测乙肝表面抗原,采用的是碘-125标记抗体。该试剂的另一个优点是其保质期很长(生产日期后十二个星期)。肝管系统是全自动的,由微处理器控制,设计用于在加入患者样本后完成肝管检测序列中的所有洗涤和示踪剂添加步骤。按照相同方案,将结果与我们小组目前使用的方法(奥斯里亚II 125法)所获得的结果进行比较。本研究对7589份血清或血浆样本进行了检测;其中献血者样本5352份;内科和外科患者样本1292份;血清标准品87份;重复检测样本367份;阳性和阴性对照血清421份;第一天进行的检测70次。153份阳性结果(2.3%)在中和前通过另一种检测方法得到确认。使用一个包含显示不同阳性程度且代表两种主要亚型的样本的参考标准品,比较了两种技术的灵敏度。在材料发放后2个月以及3个月后,我们对该标准品重复进行了检测。这种新系统比奥斯里亚II 125法更灵敏。在6644名患者中,假阳性在1.1%的病例中被发现,这优于奥斯里亚II 125法的检测结果,而且这种新方法没有假阴性。使用血清或血浆时没有差异。