FDA Approves First Test to Confirm Presence of Human T-Cell Lymphotropic Virus-I/II Antibodies

More information will be garnered from Human T-cell Lymphotropic Virus-I/II (HTLV-I/II) screenings, thanks to a new FDA approval.

The FDA today approved MP Diagnostics HTLV Blot 2.4, which will be the first FDA-licensed supplemental test for HTLV-I/II.

This test will be used to examine human serum or plasma specimens after a first test of a donor’s blood tests positive on an FDA-licensed HTLV-I/II blood donor screening test.

MP Diagnostics HTLV Blot 2.4 will provide more information to the donor about which kind of virus (HTLV-I or HTLV-II) he or she potentially has, according to the FDA. Some individuals may not know they are infected with HTLV because they may not show any symptoms or develop any diseases from the virus, though they are still able to transmit the virus to others, the FDA stated.

HTLV is transmitted via infected blood transfusions, breastfeeding, or unprotected sexual contact, and the virus is known to cause diseases such as adult T-cell leukemia/lymphoma, inflammation of the nerves in the spinal cord, among other conditions.

“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,” said Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research, in a press release.