Radioimmunoassay detection of HBsAg in hemoderivatives.

The aim of the present paper is that of developing a technique which exploiting a commercial RIA Kit (Ausria II - Abbott) could be employed for the detection of HBsAg also in products different from serum or plasma, such as hemoderivates, even when as negative control is employed the kit, made up of a pool of HBsAg and HBsAb negative plasma. In order to lower the probability of false positive and false negatives the Authors employed, in parallel with the normal Abbott technique, a modified technique, which involves the presaturation of the polystyrene beads with human serum albumin solution. This technique showed to increase the sensitivity relevant to the kit itself. The technique with successive contacts employed by the Authors allowed the carrying out of the confirmation test for those blood derivatives also, which tend to clot, both due to the treatments and for the addition of the reagents employed in the confirmation test. In order the get a better garantee in classifying as "non-reactive" a sample the Authors expect it to be timely to carry out, in addition to the direct test, a confirmation test. Samples with titrated HBsAg additions and showing C/N > 1.5 in the direct test, turned out reactive to the confirmation test. Recovery tests show, even considering the variability of the sensitivity of the kit, according to the batch and the date of use, an indication of the sensitivity of the RIA method for HBsAg detection in hemoderivatives.

Survey on controls for the presence of HBsAg in products based on hemoderivatives.

In Italy, Health Ministry provisions prohibit the marketing of products based on hemoderivatives unless they have first been controlled for the presence of HBsAg by means of radioimmunoassay. The present survey considers certificates submitted by Pharmaceutical Companies to the Health Department for permission to market their hemoderivative-based products. The results of the survey are discussed, and compared with the data obtained by the AA. in official control analyses, so as to arrive at some conclusion as to the applicability of currently employed RIA methods to HBsAg detection in hemoderivatives.

Study of methods for the detection of HBsAg and HBsAb in hemoderivatives.

For application to the control of hemoderivatives of the methods adopted for the detection of HBsAg and HBsAb in sera or plasma, using radioimmunological kits, it is necessary for the methods to have greater sensitivity and reliability, which can be achieved by employing complementary tests or by modifying certain phases of the normal methods. Particularly in the case of hemoderivatives with a high infectivity risk, application of the normal procedures entails problems of a kind such as to rule out the test altogether or to adversely affect its reliability. The preliminary data obtained with modifications of the methods according to the Abbott AUSRIA II and AUSAB RIA kits are here reported; these data seem to indicate that the reliability of the tests is improved.