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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information for Blood Establishments: DISCONTINUATION of CHIRON® RIBA® HCV 3.0 SIA (RIBA)

Important Notification
Updated: February 18, 2013

This information is intended to alert blood establishments and health care professionals about the discontinuation of the CHIRON® RIBA® HCV 3.0 SIA (RIBA) assay used to test donations of human blood or blood components.

 
The CHIRON® RIBA® HCV 3.0 SIA (RIBA) is an in vitro qualitative enzyme immunoblot assay for detection of antibodies to individual proteins encoded by the hepatitis C virus (anti-HCV) in human serum or plasma donated for transfusion or for further manufacturing.  It is intended for use as an additional, more specific test on human serum or plasma specimens found to be repeatedly reactive using a licensed anti-HCV screening test.  

 
Novartis Diagnostics, the licensed manufacturer of this immunoblot assay, has informed the Food and Drug Administration (FDA) that the production of the CHIRON® RIBA® HCV 3.0 SIA (RIBA) assay used to test donations of human blood or blood components has been discontinued. In the absence of RIBA, the FDA is providing the following information to assist blood establishments in managing donations that are repeatedly reactive (RR) on an anti-HCV screening assay.  

 
Certain licensed HCV NAT assays have been labeled with a “limited supplemental claim.”  This means that when current donor test results are RR on an anti-HCV screening test and reactive on an HCV NAT labeled with a limited supplemental claim, the reactive NAT acts as a positive supplemental test. [1] Blood establishments can use these test results in donor notification and counseling (21 CFR 630.6), and in determining the need to notify transfusion recipients under the lookback regulations (21 CFR 610.47).

 
Blood establishments have contacted FDA about using a testing algorithm in lieu of a supplemental test to provide additional information regarding donations that are RR on an anti-HCV screening test and non-reactive on an HCV NAT. As described below, this information would be used in meeting lookback requirements (21 CFR 610.47(a)(3), (b)(3)) and in donor notification (21 CFR 630.6).   

 
FDA regulations provide procedures under 21 CFR 640.120 for licensed and unlicensed blood establishments wishing to obtain an exception or alternative procedure (variance) to the requirements in Parts 600-680. FDA has determined that a variance is necessary in order for you to substitute a testing algorithm for the supplemental test referenced in 21 CFR 610.47(a)(3) and (b)(3).  Any request for a variance should describe your alternative testing algorithm. A variance to 21 CFR 610.47(a)(3) would allow you to use the results from your alternative testing algorithm in lieu of the results of a supplemental test in determining whether notification of consignees is necessary. A variance to 21 CFR 610.47(b)(3) that includes an alternative testing algorithm would eliminate the need for consignees to notify transfusion recipients based only on a RR screening test result. 
 
Blood establishments, specifically blood and plasma collection establishments, seeking a variance to the requirement in 21 CFR 610.47(a)(3) for consignee notification to include the results of a supplemental test and to the requirement in 21 CFR 610.47(b)(3) to notify transfusion recipients based on the RR screening test result may contact CBER at the address or at the phone number provided below. If you have already requested a variance to 21 CFR 610.40(e) for purposes of using a testing algorithm in lookback, we will consider your request as related to regulations 21 CFR 610.47(a)(3) and (b)(3). Blood establishments, rather than donor testing laboratories, need to apply for these variances. We are able to approve variance requests by phone but you must follow this verbal approval with a written request for approval of the variance.  Approved variances to 21 CFR 610.47(a)(3) and (b)(3) will remain in effect until the date three months following the date of FDA licensure of another supplemental test for HCV.  You should implement all exceptions or alternatives approved under 21 CFR 640.120 following existing change control procedures.  
 
Variances are not needed for you to use the test results from your alternative procedure in donor notification and counseling (21 CFR 630.6). All available information and test results (including results of a second anti-HCV screening assay) may be shared with the donor at the discretion of the blood establishment medical director.  

 
Additional information for submissions by licensed establishments is provided in 21 CFR 601.12 and in the guidance document titled: “Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture (July 2001).”
 
Center for Biologics Evaluation and Research
Office of Blood Research and Review
Division of Blood Applications
1401 Rockville Pike, Suite 200N
Rockville, MD 20852
(301) 827-3524
 
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[1] Guidance for Industry – “Lookback” for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV, dated August, 2007 and updated December, 2010.