RegulatoryOfficial

FDA CBER updates Procleix Ultrio Elite Assay entry for donor blood screening

🇺🇸 FDA CBER · Thu 29 Oct 2026

CBER's product page for Grifols' nucleic acid test lists a June 2026 approval letter alongside earlier approvals, with the indication covering blood, plasma, organ and tissue donors.

The US Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has refreshed its page for the Procleix Ultrio Elite Assay, made by Grifols Diagnostic Solutions, Inc. The page, listed under STN 125652, shows content current as of 29 October 2026. The excerpt does not say what prompted the update.

The most recent supporting document is a 10 June 2026 approval letter. It covers the Procleix Ultrio Elite Assay together with the Procleix WNV Assay and the Procleix Babesia Assay. Earlier approval letters are dated 5 November 2024, 15 June 2022, 20 November 2020, 15 October 2020 and 3 May 2018. A Summary Basis for Regulatory Action from 3 May 2018 is also listed.

The assay is a qualitative in vitro nucleic acid amplification test. It screens for HIV-1 RNA, HCV RNA and/or HBV DNA, and detects HIV-2 RNA, in plasma and serum from individual donors. These include donors of whole blood, blood components and source plasma, as well as other living donors. It may also be used to screen organ and tissue donors when specimens are taken while the heart is still beating, and to test blood from cadaveric donors. It is not intended for cord blood specimens.

The labelling also covers pooled testing. Pools of plasma or serum may contain equal aliquots from up to 16 individual specimens. Donors in scope include those of whole blood, blood components, bone marrow, peripheral blood or cord blood haematopoietic stem and progenitor cells, and donor lymphocytes for infusion. For source plasma, pools may contain up to 96 individual donations.

The assay is meant to be used alongside licensed antibody tests for HIV-1, HIV-2, HCV and hepatitis B core antigen, and licensed HBsAg tests. It is not intended to aid diagnosis of HIV-1, HIV-2, HCV or HBV infection. In defined circumstances, it can serve as a supplemental test confirming infection. This requires the specimen to be repeatedly reactive on a licensed screening test and reactive on the relevant Procleix Ultrio Elite discriminatory assay. A specimen negative in a minipool but reactive on the discriminatory assay also qualifies.

What it means for your team

  • Blood establishments should read the 10 June 2026 approval letter and the current package insert to identify any change to the labelled use or procedures.
  • Quality teams should check that pooling limits (16 for most donor types, 96 for source plasma) and the exclusion of cord blood specimens match local procedures.
  • Supplemental-test confirmation depends on a reactive licensed screening test plus the matching discriminatory assay, so algorithms should be checked against the current labelling.
  • The excerpt does not state what changed, so no operational impact should be assumed until the full CBER documents are reviewed.

Official source: FDA CBER ↗

Article written by VigiEye from the official source (FDA CBER). AI-assisted; check the source before acting.

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