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The Human T-Lymphotropic virus Type-I (HTLV-I) is an RNA retrovirus that is known to cause adult T-cell leukemia and lymphoma. The HTLV-II virus shares approximately 70% genomic homology with HTLV-I.
The MP Diagnostics™ HTLV-I/II ELISA 4.1 System is an Investigational Use Only (IUO) system that allows blood screening laboratories to use a second ELISA test for further evaluation of anti-HTLV-I/II.
View HTLV product brochures, publications and technical resources.
Many test methodologies are available worldwide for assessing the serology of HTLV-I/II. The preferred method in the United States is the use of an enzyme immunoassay (EIA) recommended by the FDA.
The 1997 FDA Guidance on HTLV-I/II testing, as well as 21CFR 640.10.e, states that reactive blood units should be further tested whenever a supplemental test has been approved for such use by FDA.
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