FDA Approves New Test to Screen for HIV in Donated Blood

MPX test detects nucleic acid from HIV-1 Group O and HIV-2

MONDAY, Jan. 5 (HealthDay News) -- The U.S. Food and Drug Administration has approved the first nucleic acid test that screens for the presence of two divergent HIV types in donated blood and tissue, according to a news release issued by the FDA on Dec. 30.

The cobas TaqScreen MPX Test, manufactured by Roche Molecular Systems Inc., detects nucleic acid from both HIV-1 Group O and HIV-2, which are types of HIV infections that are found primarily in Africa, although they have been found in the United States. The new test also detects nucleic acid from HIV-1 Group M, which is the most common form of HIV, and from hepatitis B and C.

The test is designed to be used with plasma specimens from human donations of blood components and whole blood, not with donated source plasma. It can also be used to screen tissue specimens from a donor whose heart was still beating, not a donor whose heart had stopped, the FDA notes.

"With the MPX test, blood donor testing laboratories will be able to use nucleic acid technology to screen for additional HIV strains, further assuring that donated blood and tissue are free from infection and providing better protection for patients," Jesse L. Goodman, M.D., director of the FDA's Center for Biologics Evaluation and Research, stated in the release.

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