FDA OKs Test for Human T-Cell Lymphotropic Virus Antibodies
New screening test is more specific than current FDA-licensed tests
THURSDAY, Dec. 11, 2014 (HealthDay News) -- A new screening test to detect human T-cell lymphotropic virus-I/II (HTLV-I/II) has been approved by the U.S. Food and Drug Administration.
The newly approved test -- MP Diagnostics HTLV Blot 2.4 -- is meant to supplement existing screening for the viruses, the FDA said. The diagnostic also can differentiate between the two types, HTLV-I or HTLV-II.
According to the FDA, it is required that donated blood be tested for HTLV-I/II antibodies. Currently, there are two FDA-licensed screening tests for HTLV-I/II. The MP Diagnostics HTLV Blot 2.4, however, provides blood donation sites with additional information that they can pass on to the donor -- specifically, whether HTLV-I or HTLV-II is causing the infection.
"The approval of MP Diagnostics HTLV Blot 2.4 will help blood establishments better counsel donors who have had positive results on an FDA-licensed HTLV-I/II screening test," Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research, said in an agency news release.
The new test is produced by a Singapore subsidiary of MP Biomedicals, based in Santa Ana, Calif.