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On (b)(6) 2022, grifols customer gift of hope (united states of america) reported a case of hbv transfusion transmission infection (tti) for the recipient of a heart from a beating heart organ donor.The donor of the heart was tested with serology and the procleix ultrio elite screening assays and they were both nonreactive.There was also a hbv tti event for the kidney recipient from the same donor that is documented under a separate report (2032600-2022-00007).Samples from the donor were tested on (b)(6) 2022 and gave the following results: abbott alinity anti-hbc: nonreactive, abbott alinity hbsag: nonreactive, ultrio elite screening: nonreactive.Ultrio elite ml 703564 was used for testing.The tti was discovered when the patient who received their heart transplant completed their post-operative follow-up testing (exact date unknown, approximately 4 to 6 weeks post-op) and they tested hbv positive.Additional details of the testing were requested but the only information the customer provided was that the transplant team used an hbv dna quant test.The customer declined to provide any information from the donor questionnaire, citing confidentiality.The sample tubes used for procleix (k2edta) and serology (preservative and coagulant free) testing were collected at the same time.Grifols reviewed customer reagent and storage and preparation and did not find anything unusual.The ultrio elite run report from the customer site was reviewed by grifols.There were no instrument errors.The run was normal and valid.Calibrators were valid with no unusual values.Internal control results for the sample did not indicate any issues with amplification.The sample was not tested using the ultrio elite discriminatory assays.Review of the device history record (dhr) for ultrio elite ml 703564 was completed.Dhr review confirmed that the master lot performed as expected and met all qc release sensitivity and specificity criteria for both screening and discriminatory assays.A review of grifols complaint records created for ultrio elite hbv sensitivity issues for one year 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 703564 or with the ultrio elite assay in general.An investigation into the root cause of the nonreactive hbv result on ultrio elite is ongoing.Additional information has been requested.The customer had sample available for investigational testing at grifols.Sample was delivered to grifols on (b)(6) 2022 and investigational testing is in progress.An update to this report will be filed with results of the investigational testing.
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On (b)(6) 2022, grifols customer gift of hope (united states of america) reported a case of hbv transfusion transmission infection (tti) for the recipient of a heart from a beating heart organ donor.The donor of the heart was tested with serology and the procleix ultrio elite screening assays and they were both nonreactive.There was also a hbv tti event for the kidney recipient from the same donor that is documented under a separate report (2032600-2022-00007).Samples from the donor were tested on (b)(6) 2022 and gave the following results: abbott alinity anti-hbc: nonreactive abbott alinity hbsag: nonreactive ultrio elite screening: nonreactive ultrio elite ml 703564 was used for testing.The tti was discovered when the patient who received their heart transplant completed their post-operative follow-up testing (exact date unknown, approximately 4 to 6 weeks post-op) and they tested hbv positive.Additional details of the testing were requested but the only information the customer provided was that the transplant team used an hbv dna quant test.The customer declined to provide any information from the donor questionnaire, citing confidentiality.The sample tubes used for procleix (k2edta) and serology (preservative and coagulant free) testing were collected at the same time.Grifols reviewed customer reagent and storage and preparation and did not find anything unusual.The ultrio elite run report from the customer site was reviewed by grifols.There were no instrument errors.The run was normal and valid.Calibrators were valid with no unusual values.Internal control results for the sample did not indicate any issues with amplification.The sample was not tested using the ultrio elite discriminatory assays.Review of the device history record (dhr) for ultrio elite ml 703564 was completed.Dhr review confirmed that the master lot performed as expected and met all qc release sensitivity and specificity criteria for both screening and discriminatory assays.A review of grifols complaint records created for ultrio elite hbv sensitivity issues for one year 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 703564 or with the ultrio elite assay in general.An investigation into the root cause of the nonreactive hbv result on ultrio elite is ongoing.Additional information has been requested.The customer had sample available for investigational testing at grifols.Sample was delivered to grifols on 06oct2022 and investigational testing is in progress.An update to this report will be filed with results of the investigational testing.Final report: the customer provided the donor plasma sample to grifols for investigational testing on (b)(6) 2022.Hbv quantitative testing was completed on (b)(6) 2022 investigational testing was performed by testing the sample using the hologic aptima hbv quant assay (aptima qhbv).The testing result was "not detected".Per the aptima qhbv package insert (aw-15644, rev.002), the limit of detection (lod) of the assay using the 3rd who international standard for hbv dba (nibsc 10/264, genotype a) is 4.8 iu/ml for plasma and 5.9 iu/ml for serum.Based on the aptima qhbv "not detected" result and the lod indicated in the aptima qhbv package insert, if hbv is present in the plasma sample it is at a concentration below 4.8 iu/ml.The ultrio elite package insert (gdss-ifu-000006 v7.0) shows 95% detection probability of 4.3 iu/ml with 95% fiducial limits of 3.8 - 5.0 iu/ml for the hbv who (97/750) international standard on the ultrio elite screening assay.Based on the results of hbv quantitative testing, the hbv concentration of the sample is at or below the ultrio elite screening hbv lod and therefore would not be expected to give consistently reactive results.The root cause of the nonreactive ultrio elite result is low titer sample and the ultrio elite assay is performing as designed.No further information is expected, this is the final report.
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