FDA approves first test to confirm the presence of Human T-cell Lymphotropic Virus-I/II antibodies

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA approves first test to confirm the presence of Human T-cell Lymphotropic Virus-I/II antibodies

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FDA approves first test to confirm the presence of Human T-cell Lymphotropic Virus-I/II antibodies

12/11/2014 12:51 PM EST

The U.S. Food and Drug Administration today approved MP Diagnostics HTLV Blot 2.4, the first FDA-licensed supplemental test for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II). This test is intended for use as an additional, more specific test for human serum or plasma specimens that have previously tested positive on an FDA-licensed HTLV-I/II blood donor screening test. The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay test intended to confirm infection with HTLV and to differentiate between HTLV-I and HTLV-II.

 

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