Prospective nucleic acid tests were carried out for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) using the COBAS Amplicor HIV-1 and HCV tests (Roche Diagnostics, Meylan, France) on potential organ (n=113) and cornea (n=368) donors in France to evaluate their performance and suitability for use as a complement to routine serological tests. Blood samples were collected from organ donors with preserved cardiac function after verification of cerebral death. Blood samples were collected from cornea donors post-mortem within 48 hr after death. An internal control was added to the samples before extraction to monitor each individual polymerase chain reaction (PCR). The nucleic acid tests were always interpretable in organ donors and negative in all except in 2 anti-HCV positive patients. One had an indeterminate HIV p24 antigen but was negative for HIV RNA. HIV and HCV RNA were not found in cornea donors with a negative serology but indeterminate molecular results were frequent in this group (17.6%). Cornea donors also gave significantly more (14.4%) indeterminate serological results than organ donors (1.8%) (P<0.001). This was due to the poor quality of the blood samples collected post-mortem. However, there was no correlation between indeterminate results of serological and molecular tests. There were 16/19 (84%) indeterminate serological results for HIV and 4/4 (100%) for HCV that were negative by PCR. Thus, nucleic acid tests could be useful for qualifying a donor whose serological results are indeterminate. The extraction procedures on post-mortem specimens and/or blood collection must be changed to improve the performance of nucleic acid tests.
Copyright 2002 Wiley‐Liss, Inc.