Description
This memorandum transmits Recommendations for Testing for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) in Blood Establishments, April 1992. These recommendations supersede those issued on 29 November 1990 which should be archived.
Scope & Applicability
Product Classes
6Blood component subject to the recommendations in this guidance
Specific blood component with distinct testing recommendations; Recommendations for testing Source Plasma differ from whole blood.
Blood component intended for further manufacture
Plasma derivatives whose safety was evaluated
subject to testing or pathogen reduction
Products intended for laboratory use rather than transfusion
Stakeholders
3Entities responsible for manufacture and labeling of CSP; Must follow instructions for use provided by the device manufacturer; Blood establishments that manufacture licensed blood components
Donors whose products may require specific handling
Personnel required to follow safety precautions
Regulatory Context
Attributes
1Test result status triggering regulatory action; A specific test result state for anti-HCV screening tests.; A specific test outcome status for screening assays.
Identified Hazards
Hazards
3Pathogen addressed in safety precautions
Pathogen addressed in safety precautions
General category of infectious agents in blood
Related CFR Sections (3)
- 21CFR640.66§ 640.66 Immunization of donors.
If specific immunization of a donor is to be performed, the selection, scheduling and administration of the antigen, and the evaluation of each donor's clinical response, shall be by the responsible physician. Any material used for immunization shall be either a product licensed under section 351 ofRead full regulation →
- 21CFR606.121§ 606.121 Container label.
(a) The container label requirements are designed to facilitate the use of a uniform container label for blood and blood components intended for use in transfusion or further manufacture by all blood establishments.Read full regulation →
- 21CFR606.40§ 606.40 Facilities.
Facilities shall be maintained in a clean and orderly manner, and shall be of suitable size, construction and location to facilitate adequate cleaning, maintenance and proper operations. The facilities shall:Read full regulation →
See Also (8)
- Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs: Guidance for Industry (Status: Final)
- FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc) (Status: Final)
- Use of Sterile Connecting Devices in Blood Bank Practices: Guidance for Industry (Status: Final)
- Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion: Final Guidance for Industry (Status: Final)
- Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus: Final Guidance for Industry (Status: Final)
- Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture: Final Guidance (Status: Final)
- Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components: Guidance for Industry (Status: Final)
- Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry: Guidance for Industry (Status: Final)