Food and Drug Administration - December 31, 2008
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
The cobas TaqScreen MPX Test runs on the fully-automated cobas s
201 System. It is manufactured by Roche Molecular Systems Inc.,
Richard Klein | Office of Special Health Issues | Food and Drug
Kimberly Struble | Division of Antiviral Drug Products | Food and