First FDA-licensed test approved for confirming human T-cell lymphotropic virus I/II

MP Diagnostics HTLV Blot 2.4 (MP Biomedicals) has been approved by FDA as the first FDA-licensed supplemental test for human T-cell lymphotropic virus-I/II (HTLV-I/II). It is a qualitative enzyme immunoassay test, which is to be used to confirm the presence of HTLV antibodies as well as to differentiate between HTLV-I and HTLV-II infection.

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FDA requires that donated blood is tested for HTLV-I/II antibodies because HTLV can be transmitted through blood. The use of MP Diagnostics HTLV Blot 2.4 as an additional, more-specific confirmatory assay will make a significant difference for blood donors in whom human serum or plasma specimens have previously been found to test positive on an FDA-licensed HTLV-I/II blood donor screening test.

For the 2 FDA-licensed screening tests in existence until now, the blood donation is discarded and the donor notified of the deferral if the test is positive. Additional information, however, can be given to the donor about whether or not infection with HTLV is present and which type of HTLV is causing the infection with the use of this newly approved test.

HTLV can be transmitted through not only a blood transfusion from an infected donor but also through breastfeeding and unprotected sexual contact. A group of human retroviruses, HTLV causes diseases including myelopathy and adult T-cell leukemia/lymphoma, among other illnesses.

Infection with HTLV may not result in any symptoms or signs of infection in many individuals in whom it is present. Asymptomatic carriers, however, who also may never develop a disease, are still able to transmit HTLV to others.

According to Karen Midthun, MD, the director of FDA’s Center for Biologics Evaluation and Research, “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.”