The FDA has approved the fully automated HTLV-I/HTLV-II blood-screening test from Abbott, Abbott Park, Ill, for use on the company’s Prism instrument.
Labs can use the test to screen individual donations of blood and plasma for antibodies to human T—lymphotropic virus Type I and/or human T—lymphotropic virus Type II (anti-HTLV-I/HTLV-II).
HTLV-I and HTLV-II are closely related but distinct retroviruses associated with several diseases, such as human T-cell leukemia and neurological disorders, according to the Centers for Disease Control.
Screening of the nationwide blood supply for HTLV-I/II began in 1988.
The American Association of Blood Banks reports that eight million volunteers donate about 15 million units of whole blood annually. Each donated unit of blood is tested for infectious diseases, such as hepatitis, HIV, and other retroviruses.
The assay has not been validated for use with pooled specimens, and is not intended for use on cord blood specimens, or for the laboratory diagnosis of HTLV-I/HTLV-II infection.
