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Grifols customer, (b)(6) reported that a sample was (b)(6) on another id-nat (b)(6) test but was (b)(6) when tested using the ultrio elite screening and the ultrio elite (b)(6) assays.The customer tested plasma (from the edta blood collecting tube) and platelets (from 250-300ml platelet collecting bag, acd-a solution).The sample was tested as part of routine lab screening.The customer reported the sample as (b)(6) and it was not used for donation.The customer provided the following summary of testing performed to date: (b)(6) both times when tested twice on (b)(6) elisa tests.The platelets and plasma were tested using the ultrio assay screening and ultrio (b)(6) tests with the following results (testing dates: (b)(6) 2020): plasma on ultrio elite screening - invalid.Platelet on ultrio elite screening - (b)(6).Plasma on ultrio elite screening - (b)(6).Platelet on ultrio elite (b)(6) - (b)(6).Plasma on ultrio elite (b)(6) - (b)(6).Plasma on ultrio elite (b)(6) - (b)(6).The donor platelets and plasma were tested using another unknown nat assay with the following results (testing dates: (b)(6) 2020): plasma on haoyuan in a master pool of 8 (mp8) - (b)(6).Plasma on haoyuan in mp8 - (b)(6).Plasma on haoyuan tested as individual (idt) - (b)(6).Plasma in 1:8 dilution in di water - (b)(6).Platelet on haoyuan as idt - (b)(6).The grifols ultrio elite package insert for this region (903775en, rev 006) lists whole blood, plasma, and serum as acceptable sample types that have been validated for use with the assay.Additional information about the testing of platelets at the site has been requested.The customer also reported that they sent the sample out for quantitative virus detection.The sample was tested twice using the haoyuan prenat test.On (b)(6) 2020 they received the results which gave an (b)(6) concentration of (b)(6).Table 10 in the package insert for this assay (903775en, rev 006) lists the detection probability for (b)(6) as 95% at 4.3 iu/ml with 95% fiducial limits of 3.8-5.0 iu/ml for the ultrio elite screening assay and 95% at 4.5 iu/ml with 95% fiducial limits of 4.0 to 5.3 iuml for the ultrio elite (b)(6) assay.Table 9 of the package insert shows that when (b)(6) who (97/750) analytical sensitivity panels were tested the 15 iu/ml panel had a reactive rate of 100% and the 5 iu/ml panel had a reactivity rate of 97%.According to sample (b)(6) quantitation data provided by the customer the sample concentration falls between those two values.Additional information is needed to determine why the results were discordant between ultrio elite and other methods of testing.Grifols has requested the following information in order to complete a root cause investigation: the ultrio elite master lot used for testing, additional information about the other unknown nat test and viral load test used, run data for tests performed, and confirmation on how the samples (platelet and plasma) were handled prior to testing.Per information provided by grifols support local to the testing country, it will not be possible to get sample sent back to grifols (b)(4) from (b)(6) for additional testing.When available, additional information will be provided within a follow-up report.
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Grifols customer, (b)(6) center in china, reported that a sample was hbsag positive and reactive on another id-nat hbv test but was non-reactive when tested using the ultrio elite screening and the ultrio elite hbv discriminatory (dhbv) assays.The customer tested plasma (from the edta blood collecting tube) and platelets (from 250-300ml platelet collecting bag, acd-a solution).The sample was tested as part of routine lab screening.The customer reported the sample as hbv positive and it was not used for donation.The customer provided the following summary of testing performed to date: hbsag positive both times when tested twice on hbsag elisa tests.The platelets and plasma were tested using the ultrio assay screening and ultrio dhbv tests with the following results (testing dates: 9 and 10 april 20120): plasma on ultrio elite screening - invalid.Platelet on ultrio elite screening - nonreactive.Plasma on ultrio elite screening - nonreactive.Platelet on ultrio elite dhbv - nonreactive.Plasma on ultrio elite dhbv - nonreactive.Plasma on ultrio elite dhbv - nonreactive.The donor platelets and plasma were tested using another unknown nat assay with the following results (testing dates: 9 and 10 april 20120): plasma on haoyuan in a master pool of 8 (mp8) - nonreactive.Plasma on haoyuan in mp8 - nonreactive.Plasma on haoyuan tested as individual (idt) - reactive.Plasma in 1:8 dilution in di water - reactive.Platelet on haoyuan as idt - reactive.The grifols ultrio elite package insert for this region (903775en, rev 006) lists whole blood, plasma, and serum as acceptable sample types that have been validated for use with the assay.Additional information about the testing of platelets at the site has been requested.The customer also reported that they sent the sample out for quantitative virus detection.The sample was tested twice using the haoyuan prenat test.On (b)(6) 2020 they received the results which gave an hbv concentration of 12.78 iu/ml and 7.96 iu/ml.Table 10 in the package insert for this assay (903775en, rev 006) lists the detection probability for hbv as 95% at 4.3 iu/ml with 95% fiducial limits of 3.8-5.0 iu/ml for the ultrio elite screening assay and 95% at 4.5 iu/ml with 95% fiducial limits of 4.0 to 5.3 iuml for the ultrio elite dhbv assay.Table 9 of the package insert shows that when hbv who (97/750) analytical sensitivity panels were tested the 15 iu/ml panel had a reactive rate of 100% and the 5 iu/ml panel had a reactivity rate of 97%.According to sample hbv quantitation data provided by the customer the sample concentration falls between those two values.Additional information is needed to determine why the results were discordant between ultrio elite and other methods of testing.Grifols has requested the following information in order to complete a root cause investigation: the ultrio elite master lot used for testing, additional information about the other unknown nat test and viral load test used, run data for tests performed, and confirmation on how the samples (platelet and plasma) were handled prior to testing.Per information provided by grifols support local to the testing country, it will not be possible to get sample sent back to grifols san diego from china for additional testing.When available, additional information will be provided within a follow-up report.Final report: review of the device history record (dhr) for procleix ultrio elite ml 701549 was performed.An hbv a qc panel diluted to approximately 11 iu/ml is one of the samples used to release ultrio plus master lots.The hbv panel was 100% reactive (specification: >95% reactive) with an average analyte rlu of 1,346,677 (specification >820,000) during qc release testing.Dhr review confirmed that the master lot performed as expected and met all qc release sensitivity criteria.The grifols ultrio elite package insert for this region (903775en, rev 006) lists whole blood, plasma, and serum as acceptable sample types that have been validated for use with the assay.Additional information about the testing of platelets at the site was requested but no additional information was provided.The sample was tested twice using the haoyuan prenat test.On (b)(6) 2020 they received the results which gave an hbv concentration of 12.78 iu/ml and 7.96 iu/ml.The details of the test used are unknown so test accuracy at lower concentrations could not be verified.Table 10 in the package insert for this assay (903775en, rev 006) lists the detection probability for hbv as 95% at 4.3 iu/ml with 95% fiducial limits of 3.8-5.0 iu/ml for the ultrio elite screening assay and 95% at 4.5 iu/ml with 95% fiducial limits of 4.0 to 5.3 iuml for the ultrio elite dhbv assay so the ultrio elite screening and dhbv assays should likely have given a reactive result for one of the replicates tested based on the sample viral load determined by the customer if the sample is hbv genotype a as that is the genotype of the who standard tested for the package insert data.Hbv genotypes b and c have been identified as the most common hbv strains in china and are estimated to account for approximately 95% of chinese patients.Based on this information it is likely that the positive sample was either hbv genotype b or c.Table 14 in the ultrio elite package insert (903775en, rev 006) shows the ultrio elite assay for different hbv genotypes.Hbv genotype b with a concentration of 30 c/ml had a reactive rate of 95% on ultrio elite and 97.75 on ultrio elite dhbv.Hbv genotype c with a concentration of 30 c/ml had a reactive rate of 80% on ultrio elite and 77.5% on ultrio elite dhbv.Based on the estimated concentration of the sample from the customers quantitative testing, the likelihood that the sample is hbv genotype b or c based on the region, and the reactivity rates for those genotypes in the ultrio elite pi it is not unexpected that the sample would test nonreactive on the ultrio elite assay although that could not be confirmed through additional testing.Per information provided by grifols support local to the testing country, it was not possible to get sample sent back to grifols san diego from china for additional testing so additional quantification or genotype testing of the sample could not be performed.Additional information about the testing at the customer site, such as sensitivity/specificity of the other nat test used and details regarding the dilutional testing performed, was requested but the customer did not provide an additional information.The root cause of the nonreactive results on the ultrio elite assay could not be determined based on the information provided.The customer reported the sample as hbv positive and it was not used for donation.The root cause of the nonreactive result on the ultrio elite assay could not be determined although it is likely that the hbv genotype of the sample was a factor.Review of the qc release data and a previous events search in the grifols complaint system indicate that the assay is working as designed.The investigation is complete.No additional information is expected, this is considered the final report.
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