Table of Contents
Update Rapid HIV Test Approval Requirements and Standards
Rapid HIV Tests
Summary from June 15 BPAC
Sensitivity Standard, June 15
Specificity Standard, June 15
Extending the Rapid HIV Test Standards
Revising the Rapid HIV Test Trial Requirements
Revised HIV-1 Sensitivity Study Requirements
HIV-1 Prospective Study (High Risk) Requirement
Revised HIV-1 Specificity Requirements
Revised Sensitivity and Specificity Studies
Other Revisions
Pre-Clinical HIV-1 Sensitivity Requirements
Pre-Clinical Specificity Requirements
Sensitivity Requirements for HIV-2 (no change)
For Approval of Rapid HIV Tests
FDA Contacts
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Author: Poffenberger
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