Saturday, December 10, 2011
FDA-APPROVED HIV TESTS pt 3
Abbott HIVAG-1 Monoclonal (1989)
It is intended to be used as an aid in the diagnosis and prognosis of patients with HIV-1 infection.
Device not to be sold or distributed by Abbott after December 6, 1999 in the United States, but are available Internationally. No longer shipped to US customers (2003).
Plasma Donor Screening Recommendations (1995) ... specimens that are repeatedly reactive in the screening assay but which are negative or indeterminate (invalid) by the criteria set forth for neutralization by the manufacturer should be considered INDETERMINATE.
PRE-SUME /prɪˈzum/ verb, - sumed, -sum·ing. verb (used with object) 1. to take for granted, assume, or suppose: I presume you're tired after your drive.
2. Law - to assume as true in the absence of proof to the contrary. 3. to undertake with unwarrantable boldness.
4. to undertake (to do something) without right or permission: to presume to speak for another.
verb (used without object)
5. to take something for granted; suppose. 6. to act or proceed with unwarrantable or impertinent boldness.
7. to go too far in acting unwarrantably or in taking liberties (usually followed by on or upon ): Do not presume upon his tolerance.
... “the usefulness of p24 antigen as a marker of viral load is limited since the antigen is detectable in only 20% of asymptomatic patients...”
... permanent injunction involves the company’s diagnostic devices division... In order to protect the public health, FDA sought action by the Department of Justice.
All the FDA-APPROVED HIV TESTS Here*credit to omsj.org for this list