Medicine an Surgery notes

Apr 24th, 2015
Studypool Tutor
Price: $5 USD

Tutor description

Word Count: 2087
Showing Page: 1/5
OTC HIV Rapid Tests: Issue SummaryOTC HIV Rapid Tests: Issue SummaryBelow is contextual information regarding the design of proposed studies to support marketing approvalof Over-the-Counter (OTC) home-use HIV test kits which includes an historical overview of rapid HIVtest kit approval in the United States, and key issues for consideration by the FDA Blood ProductsAdvisory Committee. Once posted, transcripts of the March 10, 2006 advisory committee meeting willbe available on the FDA website at seeks the advice of the Committee on proposed studies that would be needed to validate a homeuse HIV test kit with regard to test accuracy, test interpretation, and medical follow-up based on theprovision of informational material in place of a trained test operator and counselor.BackgroundRapid HIV Tests:Over the past four years, FDA has approved a number of rapid HIV tests of low complexity, whichare simple to use, require no special storage conditions and provide a highly accurate test resultwithin 20 minutes for the detection of antibodies to HIV. Two of these tests were found to besimple enough to perform that they received a CLIA waiver, expanding the availability of testing.FDA has required, as a condition of approval, that the lower 95% confidence bound for estimatedtest sensitivity and specificity should be 98% or greater.Whereas most HIV tests require the use of a blood specime

Review from student

Studypool Student
" Wow this is really good.... didn't expect it. Sweet!!!! "
Ask your homework questions. Receive quality answers!

Type your question here (or upload an image)

1830 tutors are online

Brown University

1271 Tutors

California Institute of Technology

2131 Tutors

Carnegie Mellon University

982 Tutors

Columbia University

1256 Tutors

Dartmouth University

2113 Tutors

Emory University

2279 Tutors

Harvard University

599 Tutors

Massachusetts Institute of Technology

2319 Tutors

New York University

1645 Tutors

Notre Dam University

1911 Tutors

Oklahoma University

2122 Tutors

Pennsylvania State University

932 Tutors

Princeton University

1211 Tutors

Stanford University

983 Tutors

University of California

1282 Tutors

Oxford University

123 Tutors

Yale University

2325 Tutors