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GUIDANCE DOCUMENT

Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors Guidance for Industry July 2001

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
99D-2213
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

To reduce infectious disease transmission by blood and blood products, donor samples from blood donations are tested for markers of pathogenic bloodborne infections, including antibodies, antigens, and nucleic acids that may indicate the presence of etiologic agents such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), human T-cell lymphotropic virus (HTLV), cytomegalovirus (CMV), syphilis, and others. The validity of screening and supplemental (confirmatory) test assay results is determined by the performance of test kit manufacturer supplied reagents labeled as Acontrols@, used in accordance with the test kit instructions.

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All written comments should be identified with this document's docket number: 99D-2213.

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