|
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.
|
|
On (b)(6) 2022, grifols customer plasma lab s.R.O.((b)(6), czech republic) reported discrepant hcv 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 (anti-hcv positive) and nonreactive in the ultrio elite assay.The sample was quarantined to prevent release for fractionation and sent to the czech national reference laboratory (nrl) for supplemental testing.Additional serology testing confirmed the sample is positive for hcv antibodies.Based on the initial serology testing performed by the customer and supplemental testing performed by nrl, the customer considers the nonreactive ultrio elite result a false negative.Additional pcr testing from nrl for hcv rna is pending.Testing results are summarized below.Initial testing for sample (b)(6): ultrio elite nonreactive (s/co 0.07) and abbott alinity s anti-hcv positive in 3 replicates (s/cos 100.39, 117.59, 116.45).Supplemental testing: architect anti-hcv reactive (s/co 9.10), biorad anti-hcv reactive (s/co 4.347), ortho anti-hcv reactive (s/co 6.087).Pending testing: hcv 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 false negative results.The reagent qc release data for ultrio elite master lot ml (b)(4) was reviewed and there were no indications of a problem with hcv sensitivity.The master lot passed all sensitivity specifications for hcv, 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.Follow up: on 08feb2022, results from the hcv pcr testing requested to nrl were received by grifols.The results are as follows: hcv rna pcr (roche hcv taqman) 0 iu/ml hcv the pcr test confirms the initial nonreactive ultrio elite result was accurate.Based on the initial and supplemental testing, sample (b)(6) is hcv rna negative and anti-hcv positive, and the procleix ultrio elite assay is working as designed.Procleix ultrio elite assay (mn 9051171) (lot number 703564) was manufactured between 11aug2020 and 03sep2020.The master lot has a kit expiration date of 15aug2022.Risk analysis: panther assay specific risk analysis for bloodbank assays, rsk-00854 rev.011 was reviewed and new risk to patient safety was not identified.Product impact: there is no impact to product.Review of the device history record (dhr) for ultrio elite ml (b)(4) was performed.Dhr review confirmed that the master lot performed as expected and met all qc release sensitivity criteria.There were no related nonconformances noted in the manufacturing record or as part of a search of the nonconformance records for this reagent lot number.A review of grifols complaint records created for ultrio elite hcv sensitivity issues from 12 months prior to the complaint date through the present as well as a review for all complaints related to ultrio elite ml (b)(4) was completed.Three other hcv potential false negatives were documented as complaints, and in each case, supplemental testing showed the samples to be hcv rna negative.The supplemental testing confirmed the initial ultrio elite nonreactive results.There is no complaint information that indicates a problem with ultrio elite hcv sensitivity or with ml (b)(4).Customer impact: the impact to the customer is a false negative result in the ultrio elite assay.A false negative result requires additional testing.Following iso 14971, grifols risk assessment is based on severity of harm or impact to human health and the probability of occurrence of harm or impact to human health.The probability of a false negative result is remote.False negative results do occur but are rare.The severity of a blood screening false negative is critical as a single blood screening false negative (fn) result can cause multiple infections if transfused.Following product safety risk management procedure, 04-03-12-sop v.9.0, the overall risk of a false negative result is acceptable.This is the final report and no additional information is expected.
|
