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Screening of blood from potential organ and cornea donors for viruses
Marcel Miédougé1, Martine Chatelut, Jean-Michel Mansuy
1Laboratoire de Virologie, Hôpital Purpan, CHU Toulouse, Toulouse, France.
Insights
Nucleic acid testing for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) can supplement serological tests in organ and cornea donors. Nucleic acid tests proved useful for indeterminate serological results, but sample quality needs improvement.
Area of Science:
- Virology
- Transplant Science
- Clinical Diagnostics
Background:
- Routine serological testing is standard for infectious disease screening in organ and cornea donors.
- Limitations exist in serological tests, particularly with post-mortem sample degradation.
- Nucleic acid testing (NAT) offers a sensitive alternative for pathogen detection.
Purpose of the Study:
- To evaluate the performance of COBAS Amplicor HIV-1 and HCV nucleic acid tests.
- To assess the suitability of NAT as a complementary screening method for organ and cornea donors.
- To compare NAT results with serological findings in different donor groups.
Main Methods:
- Prospective study involving organ donors (n=113) and cornea donors (n=368) in France.
- Blood samples tested using COBAS Amplicor HIV-1 and HCV assays.
- Internal controls used to monitor polymerase chain reaction (PCR) efficiency.
Main Results:
- NAT results were interpretable in all organ donors; 2 anti-HCV positive patients had detectable HCV RNA.
- No HIV or HCV RNA detected in cornea donors with negative serology, but indeterminate molecular results were frequent (17.6%).
- Cornea donors showed significantly higher rates of indeterminate serological results (14.4%) compared to organ donors (1.8%), attributed to post-mortem sample quality.
Conclusions:
- Nucleic acid testing can aid in qualifying donors with indeterminate serological results for HIV and HCV.
- Improvements in post-mortem specimen extraction and blood collection are necessary to enhance NAT performance.
- NAT shows potential as a valuable adjunct to serology in donor screening, especially when serological results are equivocal.
Abstract:
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.