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On (b)(6) 2022, grifols customer plasma lab s.
R.
O.
((b)(6)) reported discrepant (b)(6) results between procleix ultrio elite assay and abbott alinity s anti-hcv in an individually tested plasma donation.
The sample was simultaneously positive in serology testing ((b)(6)) and (b)(6) in the ultrio elite assay.
The sample was quarantined to prevent release for fractionation and sent to the (b)(6) for supplemental testing.
Additional serology testing confirmed the sample is positive for (b)(6) antibodies.
Based on the initial serology testing performed by the customer and supplemental testing performed by (b)(6), the customer considers the (b)(6) ultrio elite result a (b)(6).
Additional pcr testing from (b)(6) for (b)(6) rna is pending.
Testing results are summarized below.
Initial testing for sample (b)(6): ultrio elite (b)(6) (s/co (b)(6)) and abbott alinity s (b)(6) in 3 replicates (s/cos (b)(6)).
Supplemental testing: architect (b)(6) (s/co (b)(6)), biorad (b)(6) (s/co (b)(6)), ortho (b)(6) (s/co (b)(6)).
Pending testing: (b)(6) rna pcr (roche hcv taqman).
The ultrio elite run report and raw data were reviewed for the run performed.
No errors or chemistry issues were observed that might contribute to (b)(6) results.
The reagent qc release data for ultrio elite master lot ml 703564 was reviewed and there were no indications of a problem with hcv sensitivity.
The master lot passed all sensitivity specifications for (b)(6), in addition to all other analytes and specifications.
Manufacturing quality notifications (qns) were reviewed.
None were identified as possible contributors to low hcv sensitivity in the ultrio elite assay.
The procleix ultrio elite package insert (503049en rev.
005) shows hcv who (06/100) international standard 95% detection probability of 3.
0 iu/ml with 95% fiducial limits of 2.
5 to 3.
9 iu/ml for the ultrio elite screening assay.
A sample below the limit of detection of the assay would be expected to give nonreactive or intermittently reactive results.
An investigation is ongoing, this report will be updated when the supplemental pcr results are available from nrl.
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