Novartis Diagnostics, the licensed manufacturer of the CHIRON® RIBA® HCV 3.0 SIA (RIBA) recombinant immunoblot assay, has informed the Food and Drug Administration (FDA) that the production of this assay used to test donations of human blood or blood components has been discontinued. In March, 2013 Ortho Clinical Diagnostics sent notification letters informing customers of the Novartis decision.
The RIBA product — the only antibody supplemental/confirmatory test licensed in the U.S. — was used to confirm repeatedly reactive antibody results generated on the Ortho and Abbott donor screening platforms. HCV NAT assays with a limited supplemental claim can be used to confirm samples that are antibody repeatedly reactive when the NAT is also reactive. However, samples from donors with repeatedly reactive antibody test results (and whose NAT results are nonreactive in minipool or individual donation testing) cannot be confirmed using a NAT assay with a limited supplemental claim.
Of concern are the FDA required actions needed to manage donors and their prior donations. These activities include appropriate messaging for donor deferrals, notification and counseling, and activities related to appropriate consignee notification and recipient tracing — lookback. Establishments are reminded of a 45 day time limit for lookback activities (21 CFR 610.47).
The FDA has clarified that blood establishments are not required to obtain a variance for an alternative procedure to 21 CFR 610.40(e) for testing requirements for hepatitis C virus in blood donors simply because the supplemental (additional, more specific) test is not available. However, two additional points should be considered: 1) an establishment that does not obtain an alternative procedure (to the use of RIBA) must notify consignees and transfusion recipients based on the repeatedly reactive screening test alone; and 2) an establishment that uses results of any additional test(s) when notifying consignees and transfusion recipients must first obtain approval for use of an alternative procedure.
The American Red Cross (ARC) has applied for and received a variance to use an alternative procedure wherein they will use a second, different antibody screen in lieu of the RIBA strip. FDA has clarified that collection establishments who are clients of ARC testing laboratories (or any other testing lab that has obtained a similar variance) will also need an approved alternative procedure if they intend to make notifications using the results of the second, different antibody screen. These collection establishments should indicate in their request that they intend to follow the same procedure for which a variance was already granted to their testing lab.
On October 31, 2013 the FDA web page for Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 was updated to include an approved alternative procedure to 21 CFR 610.47(a)(3) and (b)(3) that may be used as a model by another establishment wishing to make a similar request. Approval for an exception or alternative procedure may be obtained from FDA by telephone but must be followed by a written request.
While this is primarily an issue for whole blood donors, HCT/P establishments will be affected if they have been performing confirmatory tests. Section VI.A.6. of "Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products" notes that the results of a confirmatory test, if negative or nonreactive, would not override a positive or reactive screening test, except for syphilis, but states, "you should consider performing confirmatory tests when a positive or reactive screening test result is received for such purposes as donor counseling or investigating discordant test results." These establishments do not need to obtain a variance in order to use the results of a second, different antibody screen when managing their donors.
Facilities generating a variance request should direct it to:
To: U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
From: Authorized Office (licensed firm or Contact for unlicensed firms)
(FDA Registration Number – if applicable)
(FDA License number – if applicable)
RE: Letter requesting an alternative procedure under the provisions of 21 CFR 640.120 regarding supplemental testing of HCV antibody repeatedly reactive units.
Read more: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm345617.htm
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