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On (b)(6) 2021, grifols customer, (b)(6), reported discordant (b)(6) results between serology and testing on the procleix ultrio elite assay for one donor sample.Blood bank (b)(6) tested the donation on (b)(6) 2021.The sample gave a (b)(6) result on the ultrio elite screening assay (ml 703038) but was (b)(6) using an abbott serology test.The sample was sent to (b)(6) for additional testing.It was tested with a roche pcr test and a roche serology test and gave the following results: (b)(6).Blood bank (b)(6) used the plasma bag from the donor to perform additional ultrio elite testing.On (b)(6) 2021, 5 replicates were tested using the ultrio eilte screening assay (ml 703038).All results were (b)(6).They also tested 1 replicate on (b)(6) 2021 using the ultrio elite dhbv assay (ml 703038) which gave a result of (b)(6).(b)(6) performed additional testing on the original sample they received using the ultrio elite (b)(6) assay (ml 702894) on (b)(6) 2021.Two replicates were tested and both gave (b)(6) results.The sample and the donor have been blocked.The donation was not released.The customer is currently arranging shipment of material from the plasma bag to grifols for investigational testing.Grifols will arrange for (b)(6) quantitative testing of the material once received.Current expected date of receipt of the material at grifols is pending an update from the customer.Review of all related run reports from blood bank (b)(6) and (b)(6) was completed.Calibrator results and internal control values were reviewed.There is no indication of any amplification issues or general problems with the runs performed.Review of the device history record (dhr) for procleix ultrio elite ml 703038 was performed.Dhr review confirmed that the master lot performed as expected and met all qc release specificity and sensitivity criteria.A review of grifols complaint records created for ultrio elite (b)(6) sensitivity issues from 3 years prior to the occurrence date through the present was completed.There is no complaint information that indicates an (b)(6) sensitivity problem with ultrio elite ml 703038 or the ultrio elite assay in general.An update to this report will be filed when the investigation is completed.
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On (b)(6) 2021, grifols customer, regionalne centrum krwiodawstwa i krwiolecznictwa w warszawle in poland, reported discordant hbv results between serology and testing on the procleix ultrio elite assay for one donor sample.Blood bank warsaw tested the donation on (b)(6) 2021.The sample gave a nonreactive result on the ultrio elite screening assay (ml 703038) but was hbsag positive using an abbott serology test.The sample was sent to the institute of hematology for additional testing.It was tested with a roche pcr test and a roche serology test and gave the following results: pcr-dna positive and anti-hbc s/co 8.66.Blood bank warsaw used the plasma bag from the donor to perform additional ultrio elite testing.On (b)(6) 2021, 5 replicates were tested using the ultrio eilte screening assay (ml 703038).All results were nonreactive.They also tested 1 replicate on 24may2021 using the ultrio elite dhbv assay (ml 703038) which gave a result of nonreactive.The institute of hematology performed additional testing on the original sample they received using the ultrio elite dhbv assay (ml 702894) on (b)(6) 2021.Two replicates were tested and both gave reactive results.The sample and the donor have been blocked.The donation was not released.The customer is currently arranging shipment of material from the plasma bag to grifols for investigational testing.Grifols will arrange for hbv quantitative testing of the material once received.Current expected date of receipt of the material at grifols is pending an update from the customer.Review of all related run reports from blood bank warsaw and the institute of hematology was completed.Calibrator results and internal control values were reviewed.There is no indication of any amplification issues or general problems with the runs performed.Review of the device history record (dhr) for procleix ultrio elite ml 703038 was performed.Dhr review confirmed that the master lot performed as expected and met all qc release specificity and sensitivity criteria.A review of grifols complaint records created for ultrio elite hbv sensitivity issues from 3 years prior to the occurrence date through the present was completed.There is no complaint information that indicates an hbv sensitivity problem with ultrio elite ml 703038 or the ultrio elite assay in general.An update to this report will be filed when the investigation is completed.Follow up information: review of the device history record (dhr) for procleix ultrio elite ml 703038 was performed.Dhr review confirmed that the master lot performed as expected and met all qc release sensitivity and specificity criteria.Hbv qc panels diluted to approximately 11 iu/ml and 4 iu/ml are used to release ultrio elite master lots.The hbv 11 iu/ml panel was 100% reactive (specification: >95% reactive) with an average analyte rlu of 1,398,668 (specification: >820,000) during qc release testing.The hbv 4 iu/ml panel was 100% reactive (specification: >6%).The procleix ultrio elite package insert (503049en rev.005) shows hbv who (97/750) international standard 95% detection probability of 4.3 iu/ml with 95% fiducial limits of 3.8-5.0 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.The original sample gave nonreactive results on the ultrio elite screening assay (ml 703038) when tested by blood bank warsaw and reactive results on the ultrio elite dhbv assay (ml 702894) when tested by the institute of hematology.The plasma bag gave nonreactive results on the ultrio elite screening and dhbv assays (ml 703038) when tested by blood bank warsaw, respectively.The three runs performed by blood bank warsaw using ml 703038 were done using three different ultrio elite ml 703038 kits.There is no indication based on the qc release data for ml 703038 or the previous events search that the nonreactive results at blood bank warsaw on ml 703038 are due to the master lot.Material from the donation plasma bag was returned to grifols san diego for additional testing.The sample was sent out to a reference lab for hbv quantitation testing because the serology testing results confirmed that the sample is likely hbv positive.The results of the hepatitis b virus (hbv) by quantitative naat were listed as <10 detected iu/ml.The quantitative range of the assay is 1.00-9.00 log iu/ml (10-1,000,000,000 iu/ml).The results report for the quantitative testing notes the following: hbv dna detected, but at a level below 10 iu/ml.Hbv dna concentration is below the lower limit of quantitation of the assay.Actual concentration of the sample could not be determined because it was below the limit of detection of the quantitative assay used for investigational testing, but the nonreactive results on the ultrio elite screening and dhbv assays in conjunction with the serology results and viral load testing results indicate that hbv was present in the sample but was below the limit of detection of the ultrio elite assay.No further information is expected, this is the final report.
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