Detection of anti-HIV antibodies in preparations of human immunoglobulins. A collaborative group study

This paper reports the results of a study organized by the Istituto Superiore di Sanità (Rome, Italy) and carried out in collaboration with several national laboratories. Its aim was to ascertain whether diagnostic kits for detecting anti-HIV antibodies in human serum can also be used to detect the same antibodies in human immunoglobulins. Thirty-three lots of immunoglobulins supplied by six pharmaceutical companies present in Italy were examined using different procedures. On the basis of the results of this study it can be concluded that i. anti-HIV antibodies can be detected in immunoglobulins by means of commercial reagents; ii. a preliminary dilution of immunoglobulin samples should not be made; iii. Western blot method appears to be the 'reference' test; however, competitive EIA tests are equally valuable if a negative control made up of anti-HIV-negative Igs is employed; iv. Igs examination for anti-HIV antibody represents an indirect control on a correct donors' screening procedure.