Ultrio and Ultrio Plus non‐discriminating reactives: false reactives or not?

Charlewood, Richard; Flanagan, Peter

doi:10.1111/j.1423-0410.2012.01624.x

Cited by 28 publications

(48 citation statements)

References 5 publications

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“…Individuals with occult HBV infections may, over time, have undetectable anti‐HBc and anti‐HBe and in some cases, HBV DNA may be the sole marker . The low levels of HBV DNA present in serum of individuals with an occult HBV infection can result in samples with discordant NAT results; such samples may be repeat reactive with the MPX test but nonreactive when tested with the discriminatory tests . In this study, approximately one‐third (19/59, 32.2%) of the reactive samples were nonreactive with the discriminatory tests.…”

Section: Discussionmentioning

confidence: 66%

Routine screening of blood donations at Qingdao central blood bank, China, for hepatitis B virus (HBV) DNA with a real‐time, multiplex nucleic acid test for HBV, hepatitis C virus, and human immunodeficiency virus Types 1 and 2

Yang

Liu

et al. 2013

Transfusion

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Section: Discussionmentioning

confidence: 66%

Routine screening of blood donations at Qingdao central blood bank, China, for hepatitis B virus (HBV) DNA with a real‐time, multiplex nucleic acid test for HBV, hepatitis C virus, and human immunodeficiency virus Types 1 and 2

Yang

Liu

et al. 2013

Transfusion

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“…A clear association with a positive anti-HBc status was found, and about 34% of these were positive in an alternative HBV NAT or repeated mutiplex Ultrio or Ultrio Plus testing. Therefore, the authors concluded ‘that false reactivity cannot be presumed when a donor fails to discriminate' [15]. Two other studies, which compared up to seven different HBV NAT assays, came to a similar conclusion for anti-HBc-positive donors because HBV DNA concentrations can be very low in occult hepatitis B (HBsAg negative, anti-HBc positive) [16,17].…”

Section: Discussionmentioning

confidence: 67%

“…A previous study already addressed the problem of initially reactive results, which were negative in (non-diluted) discriminatory testing, using a large group of blood donors tested by the Ultrio and UltrioPlus assay [15]. A clear association with a positive anti-HBc status was found, and about 34% of these were positive in an alternative HBV NAT or repeated mutiplex Ultrio or Ultrio Plus testing.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Procleix Ultrio Elite Assay and the Panther-System for Individual NAT Screening of Blood, Hematopoietic Stem Cell, Tissue and Organ Donors

Heim¹

2016

Transfus Med Hemother

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Background: The performance of the multiplex Procleix Ultrio Elite assay as individual donor nucleic acid test (ID-NAT) for the detection of HIV-1, HIV-2, HCV, and HBV was evaluated in a retrospective, single center study. Methods: ID-NAT results of 21,181 blood donors, 984 tissue donors, 293 hematopoietic stem cell donors and 4 organ donors were reviewed in synopsis with results of serological screening and additional discriminatory and repetitive NAT in case of positive donors. Results: Specificity of the initial Procleix Ultrio Elite assay was 99.98% and after discriminatory testing 100.00%. Initially invalid results were observed in 75 of 21,181 blood donors (0.35%) but 16 of 984 tissue donors (1.62%, p < 0.001) which included non-heart-beating (‘cadaveric') donors. All these had valid negative ID-NAT results after repeated testing or testing of 1:5 diluted specimens in case of tissue donors. Occult hepatitis B (defined here as HBV DNAemia without HBsAg detection) was demonstrated by ID-NAT in two anti-HBc-positive tissue donors and suspected in two other tissue donors, where a definite diagnosis was not achieved due to the insufficient sample volumes available. Conclusion: The Procleix Ultrio Elite assay proved to be specific, robust and rapid. Therefore, routine ID-NAT may also be feasible for organ and granulocyte donors.

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“…Several authors have pointed out that the blood screening for HBV often gives inconclusive results [12-14]. They argue that the cause of such questionable results is due to FP IR-NAT, OBI, or window-period donations.…”

Section: Discussionmentioning

confidence: 99%

Safe-Testing Algorithm for Individual-Donation Nucleic Acid Testing: 10 Years of Experience in a Low-Prevalence Country

Stolz

Gowland

Tinguely

et al. 2019

Transfus Med Hemother

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Introduction: A highly sensitive and specific nucleic acid test (NAT) for the blood-borne viruses human immunodeficiency virus (HIV), hepatitis C (HCV), and hepatitis B (HBV) is essential for the safety of blood components. Since more than 2 decades, NAT screening of blood donations has become standard in developed countries that have implemented the individual-donation (ID-NAT) and mini-pool NAT (MP-NAT) approaches. With this powerful technique, confirmation of initial reactive (IR) NAT samples becomes a challenge. Different algorithms are currently in use to eliminate false reactive results. To show that the algorithm implemented in 2007, that uses repeat testing of IR samples in duplicate runs, is a safe strategy, especially in low endemic countries, data from a 10-year experience of ID-NAT were extensively analyzed when follow-up data were available. Methods: From July 2007 to December 2014, the Procleix Ultrio assay on a Procleix Tigris system, and from January 2015 to December 2017, the cobas MPX on a cobas 8800 platform, were used for ID-NAT screening. All IR samples were subjected to repeat testing in duplicate independent runs. Only when both tests remained negative were the products released. Donor data from the last 10 years were investigated retrospectively, looking for the reoccurrence of a reactive result in a follow-up sample. Only those donors with at least an x + 1 donation result were included for the confirmation of a false reactive result. Results: From the 1,830,657 donations tested, 2,450 samples were IR (0.13%); only 228 were repeat reactive ([RR], 18 HIV, 61 HCV, and 149 HBV samples), and 2,222 were non-RR (0.12%). Follow-up data were available from 1,267 donors (57%) for further analysis. All except one of these donors were ID-NAT-negative in all follow-up samples. The one exception was from a donor who acquired a fresh HBV infection 10 years after the IR donation (in the x + 28 donation) and subsequently seroconverted. Subsequent serological tests from all succeeding donations (x + 1, x + 2, etc.) were negative in all the other cases, proving that no seroconversion took place after the IR ID-NAT result. Conclusions: The algorithm to deal with IR ID-NAT donations using duplicate repeat testing is very safe and cost-effective in low-prevalence countries. There is no unnecessary destruction of blood products, no counseling of false reactive donors, and also no need to add further complexity to the screening algorithm.

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Ultrio and Ultrio Plus non‐discriminating reactives: false reactives or not?

Abstract: These findings suggest that their HBV DNA levels are around the assay's limit of detection, that false reactivity cannot be presumed when a donor fails to discriminate and that caution should be applied when deciding whether to continue accepting donations from such donors.

Cited by 28 publications

References 5 publications

Routine screening of blood donations at Qingdao central blood bank, China, for hepatitis B virus (HBV) DNA with a real‐time, multiplex nucleic acid test for HBV, hepatitis C virus, and human immunodeficiency virus Types 1 and 2

Routine screening of blood donations at Qingdao central blood bank, China, for hepatitis B virus (HBV) DNA with a real‐time, multiplex nucleic acid test for HBV, hepatitis C virus, and human immunodeficiency virus Types 1 and 2

Evaluation of the Procleix Ultrio Elite Assay and the Panther-System for Individual NAT Screening of Blood, Hematopoietic Stem Cell, Tissue and Organ Donors

Safe-Testing Algorithm for Individual-Donation Nucleic Acid Testing: 10 Years of Experience in a Low-Prevalence Country

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