Lostia O, Lorenzini P, Maroccia E
Boll Ist Sieroter Milan. 1983 Nov 30;62(5):381-93.
Our aim was to check the relative sensitivity of the various commercial kits available on the Italian market for the detection of hepatitis B virus surface antigen (HBsAg) in its two subtypes ay and ad. To this end, panels from different producers were compared by parallel sensitivity assays of several kits. It was found that the kits revealed different sensitivities depending on the panel used, and that sensitivity curves were not parallel. Given the lack of uniformity of response in the various panels currently available, we preferred to use two panels prepared at the Istituto Superiore di Sanità, one for each of the aforementioned subtypes. These HBsAg serial-concentration preparations were used to measure the sensitivity of the different kits on the basis of distinct methodological principles, i.e. RIA, ELISA and RPHA. These are currently considered the most sensitive methodologies and are used for kits classified as belonging to the 3rd generation. For each kit we used the procedure indicated by its manufacturer as being the most sensitive. For some of the kits we adopted all procedures in parallel recommended by respective manufacturers for different conditions of use. Sensitivity was found to be a function of lot, kit, methodology and procedure used. For the RIA and ELISA kits, we also used a modified method in parallel with the normal procedures. This method consisted in presaturating the solid phase in a solution of bovine albumin serum and was generally shown to increase the sensitivity of the kit adopted. For the majority of the kits examined, as well as the direct tests, a confirmatory test was also used, i.e. a specific inhibition test to verify the positivity revealed. In this way an increase in the sensitivity of the sample was also obtained.
我们的目的是检测意大利市场上各种商用试剂盒对乙肝病毒表面抗原（HBsAg）两种亚型ay和ad的相对敏感性。为此，通过对几种试剂盒进行平行敏感性分析，比较了不同生产商的检测板。结果发现，试剂盒的敏感性因所使用的检测板而异，且敏感性曲线并不平行。鉴于目前市面上各种检测板的反应缺乏一致性，我们更倾向于使用由高等卫生研究院制备的两种检测板，每种检测板对应上述一种亚型。这些HBsAg系列浓度制剂被用于根据不同的方法学原理，即放射免疫分析（RIA）、酶联免疫吸附测定（ELISA）和反向被动血凝试验（RPHA），来测量不同试剂盒的敏感性。这些方法目前被认为是最敏感的方法，用于归类为第三代的试剂盒。对于每个试剂盒，我们采用其制造商指定的最敏感的程序。对于一些试剂盒，我们并行采用了各制造商针对不同使用条件推荐的所有程序。结果发现，敏感性是所使用的批次、试剂盒、方法学和程序的函数。对于RIA和ELISA试剂盒，我们还并行使用了一种与常规程序不同的改良方法。该方法包括在牛血清白蛋白溶液中对固相进行预饱和，总体上显示出提高了所采用试剂盒的敏感性。对于大多数检测的试剂盒以及直接检测，还使用了确证试验，即特异性抑制试验来验证所显示的阳性结果。通过这种方式，样本的敏感性也得到了提高。
