Food and Drug Administration - May 25, 2007

On May 23, 2007, FDA approved the Procleix Ultrio Assay on the fully automated Procleix TIGRIS system manufactured by Gen-Probe Inc., of San Diego, California, and marketed by Chiron Corporation. This is a fully automated qualitative in vitro nucleic acid test (NAT) to screen for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) RNA in donated blood from donors of whole blood, blood components, or source plasma. It is also licensed to screen individual organ donations from living donors, heart-beating organ donors, and cadaveric (non-heart-beating) organ donors. The capability of full automation will reduce human error and accelerate blood screening, enhancing blood safety.

On May 11/2007, FDA granted marketing approval to two HIV-1 PCR assays for use in managing the treatment HIV infection.

The Abbott RealTime HIV-1 Assay, made by ABBOTT Molecular, Inc., is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantitation of Human Immunodeficiency Virus type 1 (HIV-1) on the automated m2000 System in human plasma from HIV-1 infected individuals over the range of 40 to 10,000,000 copies/mL. The Abbott RealTime HIV-1 assay is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. (Product label)

The COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, made by Roche Diagnostics is an automated PCR test, indicated for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acid in human plasma (viral load) for use in conjunction with clinical presentation and other laboratory markers. The test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. It can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in plasma HIV-1 RNA levels during the course of antiretroviral treatment. (Product label)

Neither the Abbott RealTime nor the COBAS AmpliPrep/COBAS TaqMan HIV-1 assay is intended to be used as a donor screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.

Richard Klein | HIV/AIDS Program Director | Office of Special Health Issues | Food and Drug Administration

SOURCE: Food and Drug Administration (FDA).

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