Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I)

Issue Date: July 19, 1996
Issued by: Center for Biologics Evaluation and Research
Topic(s): Blood, Blood Products
Status: Final

Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I)

The attached recommendations by the Food and Drug Administration (FDA) to blood and plasma establishments concern the quarantine and disposition of prior collections of blood, blood components and Source Plasma from a donor who subsequently tests repeatedly reactive for hepatitis B surface antigen (HBsAg), antibody to hepatitis B core (anti-HBc), antibody to hepatitis C virus (anti-HCV), or antibody to human T-lymphotropic virus, type I (anti-HTLV-I).

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