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FDA approves supplemental HTLV-I/II test
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The FDA has approved MP Biomedicals’ supplemental confirmation test for human T-cell lymphotropic virus types I and II, according to a press release.
A qualitative enzyme immunoassay intended to confirm infection in samples that already have tested positive for human T-cell lymphotropic virus-I/II (HTLV-I/II), MP Diagnostics HTLV Blot 2.4 is able to specify between the two retroviruses. It is the first supplemental test for HTLV-I/II licensed by the FDA.
“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, MD, director for the FDA’s Center for Biologics Evaluation and Research, said in a press release.
Karen Midthun
HTLV is a group of infectious human retroviruses that may lead to adult T-cell leukemia/lymphoma and myelopathy, among other conditions. They can be transmitted through breast-feeding, unprotected sexual contact or blood transfusion.
Because people with HTLV appear asymptomatic, the FDA requires HTLV-I/II antibody tests for all blood donors. Upon HTLV-positive screening, blood establishments will be able to confirm and identify the type of infection before informing donors of their deferral.
MP Diagnostics HTLV Blot 2.4 is manufactured by MP Biomedicals’ Asia Pacific division in Singapore.