FDA OKs Blood Test Distinguishing Between HTLV-I and HTLV-II

Disclosures

December 11, 2014

The US Food and Drug Administration (FDA) today approved a blood screening test that distinguishes between human T-lymphotropic virus type I (HTLV-I) and HTLV-II, which can cause adult T-cell leukemia/lymphoma and myelopathy.

The approval comes as good news for blood donation centers that screen blood for the two retroviruses. Until now, they have relied on two FDA-approved tests that can identify HTLV-I and HTLV-II, but not tell them apart. Donations that test positive for the retroviruses are discarded, but blood establishments have one more job to do: notify the donor why his or her blood was rejected, and provide information about the health risks posed by the viruses.

The new test, called the MP Diagnostics HTLV Blot 2.4 (MP Biomedicals Asia Pacific), will allow blood establishments to tell donors exactly what HTLV virus they have, the FDA said in a news release. The qualitative enzyme immunoassay test is intended for serum or plasma specimens that have already tested positive for HTLV-I/II with a less discriminating screening technology.

HTLV-I/II can be transmitted through unprotected sex, breast-feeding, or a blood transfusion from an infected donor. Individuals with either retrovirus may not know they are infected because the retrovirus may not produce any signs or symptoms, or in many cases, it may never result in a disease.

More information about today's decision is available on the FDA website.

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