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FDA approval of NAT for detection of HIV-2, HIV-1 Groups O and M, and Hepatitis B and C

On December 30, 2008, FDA approved the first nucleic acid test (NAT) that screens for the presence of two divergent types of HIV in donated blood plasma and human tissue. Nucleic acid is the term commonly used to refer to the chemical compounds that make up the genetic material in the virus. The new FDA-approved test detects nucleic acid from HIV-2 and from HIV-1 Group O. HIV-2 infections and HIV-1 Group O infections are predominantly found on the African continent. Some cases of infection with these two types of viruses have also been detected in the United States.

The new test, called cobas TaqScreen MPX Test, will allow blood donor testing laboratories to use nucleic acid technology to screen for additional the HIV strains, further assuring that donated blood and tissue are free from infection and providing better protection for patients. However, FDA is not requiring screening with the new test at this time.

In addition to HIV-2 and HIV-1 Group O, the MPX test simultaneously detects nucleic acid from the most common form of HIV, HIV-1 Group M, as well as the Hepatitis C Virus and the Hepatitis B Virus.

The MPX test is designed for use with plasma specimens from human donors of whole blood and blood components, but not for testing donated source plasma, which is collected specifically for further processing and manufacturing.

The test is also intended for screening tissue specimens obtained from living donors whose heart is still beating. It is not intended for use on specimens from donors whose heart is no longer beating.

The cobas TaqScreen MPX Test runs on the fully-automated cobas s 201 System. It is manufactured by Roche Molecular Systems Inc., Pleasanton, Calif.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration 

Page Last Updated: 08/13/2014
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