First Supplemental HTLV-I/II Infection Test Approved

The Food and Drug Administration (FDA) has approved MP Diagnostics HTLV Blot 2.4, the first supplemental test for Human T-Cell Lymphotropic Virus-I/II (HTLV-I/II).

The HTLV Blot 2.4 is a qualitative enzyme immunoassay test indicated for use as a more specific test for human serum or plasma specimens that have previously tested positive on a licensed HTLV-I/II blood donor screening test. It is meant to confirm HTLV infection and to differentiate between HTLV-I and HTLV-II.

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There are currently two FDA-licensed screening tests for HTLV-I/II used in testing blood samples from a donor. If the sample tests positive, the HTLV Blot 2.4 can distinguish which virus type is causing the infection and can provide further information to the donor.

For more information visit FDA.gov.