Update Rapid HIV Test Approval Requirements and Standards

11/30/01


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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

Author: Poffenberger