Comparison of Human T Cell Leukemia Virus-1/2 (HTLV-1/2) screening assays in South America: implications in the loss of blood units.

GABRIELA PATACCINI, CAMILA CÁNEPA, CECILIA M DELFINO, J SALIDO, J BLEJER, A ALTER,R FERNÁNDEZ, E RODRÍGUEZ, W PEDROZO, R MALAN, E IRIARTE, G DUARTE, V SCHNEIDER, S BONTTI, C SALOMÓN, M BORDA, M BIGLIONE, C BERINI1

Monteal

Congreso; 16 th International Conference on Human Retrovirology and Related Viruses; 2013

COMPARISON OF HUMAN T CELL LEUKEMIA VIRUS-1/2 (HTLV-1/2) SCREENING ASSAYS IN ARGENTINA: IMPLICATIONS IN THE LOSS OF BLOOD UNITS In 2005, the detection of HTLV antibodies became mandatory in Argentinean blood banks. However, there is no recommendation on how to perform the screening. As a consequence, there is a variable number of HTLV false positives depending on the kit used. The aim of the present study was evaluate the performance of six commercial screening tests available currently for the initial diagnosis of HTLV-1/2 infection in South America. The positive panel included 14 HTLV-1 and 13 HTLV-2 samples confirmed by WB (HTLV-1/2 MP Diagnostics). The negative panel included 233 samples obtained from 5 different institutions collected either in a day or along 10 consecutive days, which used Architect (n=47), Diapro (n=46), MP (n=45), Murex (n=47) or Serodia (n=48). All of them were confirmed by n-PCR. The sensitivity for all HTLV diagnostic kits was 100.0%. The most specific test was Serodia (PA) (99,1%; 2/260), followed by ELISAs: Celquest (98.3%, 4/260), Murex (97.8%; 5/260), MP - Architect (97.4%; 6/260) and Diapro (93,1%; 16/260). According to this data, 2 to 16 blood units out of 233 should be discarded due to false positive results in a period of 10 days (depending on the institution and the kit used). This data should be considered when choosing the assays not only to obtain an optimal efficiency on HTLV-1/2 diagnosis and to increase the number of potential blood units but also to decrease the circulation of anxious individuals without a final result and to lower the overall cost?benefits of the diagnosis in the health care system.