Donor screening for human T-cell lymphotrophic virus 1/2: changing paradigms for changing testing capacity.
Organ Procurement and Transplant Network (OPTN) policy currently requires the testing of all potential organ donors for human T-cell lymphotrophic virus (HTLV)-1/2. Most Organ Procurement Organizations (OPO) use the Abbott HTLV-I/HTLV-II Enzyme Immunoassay (EIA). This assay will no longer be manufactured after December 31, 2009; the only commercially available FDA-licensed assay will be the Abbott PRISM HTLV-I/II assay which poses many challenges to OPO use for organ donor screening. As a result, screening donors for HTLV-1/2 in a timely manner pretransplant after December 31, 2009 will be challenging. The true incidence of HTLV-1 in United States (U.S.) organ donors is not well described but appears to be low ( approximately 0.03-0.5%). HTLV-1 is associated with malignancy and neurological disease; HTLV-2 has not been convincingly associated with disease in humans. Donors that are HTLV-1/2 seropositive are infrequently used despite most results being either false positive or resulting from HTLV-2 infection. There is urgent need to encourage the development of assays, instruments and platforms optimized for organ donors that can be used to screen for transmissible disease in donors; these must have appropriate sensitivity and specificity to identify all infections while minimizing organ loss through false positive testing.
Kaul
D R
DR
Department of Internal Medicine, Division of Infectious Diseases, University of Michigan Medical School, Ann Arbor, MI, USA. kauld@umich.edu
Taranto
S
S
Alexander
C
C
Covington
S
S
Marvin
M
M
Nowicki
M
M
Orlowski
J
J
Pancoska
C
C
Pruett
T L
TL
Ison
M G
MG
D046148:Donor Selection; D015368:Human T-lymphotropic virus 1 / Q000302:isolation & purification*; D015367:Human T-lymphotropic virus 2 / Q000302:isolation & purification*; D006801:Humans; D007124:Immunoenzyme Techniques; D008297:Male; D012680:Sensitivity and Specificity; D013601:T-Lymphocytes; D014019:Tissue Donors; D009927:Tissue and Organ Procurement; D014481:United States; D014780:Viruses