BACKGROUND Transplant professionals must be able to rely on organ and tissue screening tests to accurately detect the presence of viruses and their antibodies. Antiviral antibody tests may give false negative results during the “window” period, an interval of between the time of viral infection and the production of measurable antibodies. In 2004 our laboratory began augmenting the existing donor antibody screening by introducing NAT testing for HIV-1 & HCV. Since then we have accumulated a large body of data related to NAT for organ and tissue donors.

AIM To share our data regarding the long-term performance of commercial NAT assay developed specifically for screening.

METHODS MNIT tested specimens from prospective organ and tissue donors from the UNOS regions 5, 6 and 8; a 54 Million population area representing 9 Organ Procurement Organizations (OPO); with donors recruited from >800 hospitals.The assay used was the Procleix® Duplex HIV-1/HCV Assay (GenProbe™/Novartis, San Diego, California).

RESULTS Between 09/2004 and 11/2011 we tested 21,242 organ and tissue donors (7,924 NAT runs). Nine % of runs were invalid mostly due to operator errors or insufficient number of valid calibrators; resolved using manufacturer’s recommended measures. Among 9179 organ donors we identified 3 cases of NAT reactive donors with no HIV or HCV serological markers, one of which had no donor history of high risk behavior.

CONCLUSIONS Our 7 years experience with TMA NAT provides a unique opportunity to address the ongoing controversy about the NAT for organ donor screening. Presuming the only case of NAT reactivity with no risk factors, is an unconfirmed false positive result, it would mean a 0.01% false positives. Contrary to the prevailing opinion that NAT produces many false positive results leading to loss of organs, these events are rare and negligible in well designed laboratories with properly chosen assays.

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