Vaccines, Blood & Biologics
COBAS TaqScreen MPX Test
Proper Name: Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA Assay
Tradename: COBAS TaqScreen MPX Test
Manufacturer: Roche Molecular Systems, Inc, License No. 1636
In the February 26, 2009 Corrected Approval Letter. Correction is made to (1) reflect that specimens from "other living donors" are not included in those specimens that can be tested in pools of up to six (change in original second paragraph, line 2), (2) clarify the claim for detection of HIV-1 Group O RNA and HIV-2 RNA (change in original second paragraph line 7), and (3) clarify that the test may be used to screen donations of Source Plasma under certain conditions (change in original third paragraph, line 1).
Supporting Documents
November 20, 2009 Approval Letter - cobas TaqScreen MPX Test
To include the additional claim of testing samples from source plasma donors in pools comprised of up to 96 individual donations.August 27, 2009
To include testing for HIV-1 Group O and Group M RNA , HIV-2 RNA, HCV RNA, and HBV DNA in post mortem cadaveric (non-heart beating) donors using an individual testing format.February 26, 2009 Corrected Approval Letter - COBAS TaqScreen MPX Test
This letter has been corrected to clarify the indications for use.December 30, 2008 Approval Letter - COBAS TaqScreen MPX Test
Intended to be used as a screening test for individual human donors, including donors of whole blood and blood components, and other living donors for the presence of HIV-1 Group M RNA, HCV RNA and HBV DNA.FDA Approves First Nucleic Acid Test to Screen for Additional Types of HIV in Donated Blood and Tissue
Press Release: 12/30/2008
Contact FDA
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
