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Published on: December 1, 2011
Donor screening for human T-cell lymphotrophic virus 1/2: changing paradigms for changing testing capacity
D R Kaul1, S Taranto, C Alexander
1Department of Internal Medicine, Division of Infectious Diseases, University of Michigan Medical School, Ann Arbor, MI, USA. kauld@umich.edu
Summary
Organ donor screening for human T-cell lymphotrophic virus (HTLV)-1/2 faces challenges due to an assay discontinuation. New screening methods are needed to ensure timely testing and minimize organ loss from false positives.
Area of Science:
- Transplant immunology
- Virology
- Public health
Background:
- Organ Procurement and Transplant Network (OPTN) policy mandates human T-cell lymphotrophic virus (HTLV)-1/2 testing for organ donors.
- Current screening relies on Abbott HTLV-I/HTLV-II Enzyme Immunoassay (EIA), discontinued after December 31, 2009.
- The sole FDA-licensed replacement, Abbott PRISM HTLV-I/II, presents significant challenges for Organ Procurement Organizations (OPOs).
Purpose of the Study:
- To highlight the challenges in timely pre-transplant organ donor screening for HTLV-1/2 post-December 31, 2009.
- To address the need for optimized assays for organ donor screening.
- To improve the accuracy of HTLV-1/2 detection in organ donors, minimizing false positives.
Main Methods:
- Review of current OPTN policy and OPO screening practices.
- Analysis of the impact of the Abbott HTLV-I/HTLV-II EIA discontinuation.
- Discussion of the limitations of the Abbott PRISM HTLV-I/II assay for organ donor screening.
Main Results:
- The incidence of HTLV-1 in U.S. organ donors is low (0.03-0.5%).
- HTLV-1 is linked to malignancy and neurological disease; HTLV-2 is not definitively associated with human disease.
- Seropositive donors are rarely used, often due to false positives or HTLV-2 infection.
Conclusions:
- Timely pre-transplant screening for HTLV-1/2 will be difficult after the Abbott EIA discontinuation.
- There is an urgent need for new, optimized assays for organ donor screening.
- Assays must balance sensitivity and specificity to accurately identify infections and reduce organ wastage from false positives.
