Head‐to‐head comparison of two transcription‐mediated amplification assay versions for detection of hepatitis <scp>B</scp> virus, hepatitis <scp>C</scp> virus, and human immunodeficiency virus <scp>T</scp>ype 1 in blood donors

Grabarczyk, Piotr; Drimmelen, Harry van; Kopacz, Aneta; Gdowska, Jolanta; Liszewski, Grzegorz; Piotrowski, Dariusz; Górska, Joanna; Kuśmierczyk, J.; Candotti, Daniel; Łętowska, Magdalena; Lelie, Nico; Brojer, Ewa

doi:10.1111/trf.12190

Cited by 34 publications

(79 citation statements)

References 27 publications

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“…RDEs and residual transmission risk for ID‐, MP8‐, and MP16‐NAT were calculated using an RDE modeling spreadsheet with the following input parameters: The number of screened donations from lapsed or repeat (or lapsed plus repeat) donors during the study period; The number of HCV infections in the screened lapsed and/or repeat donations identified by ID‐NAT or anti‐HCV serologic screening or both; The harmonic mean of the interdonation intervals preceding detected infections; HCV viral doubling time of 0.45 days; 50% minimum infectious dose (MID 50 ) of 3.16 virions; ID‐NAT 95 and 50% limits of detection of 16.3 and 2.2 HCV copies/mL, respectively; Transfused plasma volume of 20 mL for RBC units and 200 mL for fresh‐frozen plasma (FFP) units, assuming that all infectivity is attributable to plasma viremia. …”

Section: Methodsmentioning

confidence: 99%

Relative efficacy of nucleic acid amplification testing and serologic screening in preventing hepatitis C virus transmission risk in seven international regions

Bruhn

Lelie²,

Busch

et al. 2015

Transfusion

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Section: Methodsmentioning

confidence: 99%

Relative efficacy of nucleic acid amplification testing and serologic screening in preventing hepatitis C virus transmission risk in seven international regions

Bruhn

Lelie²,

Busch

et al. 2015

Transfusion

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“…Multiple replicate ID‐NATs were performed in a large number of donor samples from this latter group to determine the proportion in whom low‐level viremia (indicative of so‐called “occult HCV infection”) was demonstrable. By comparing the viral concentrations in the three infection stages against HCV‐RNA reference panels and infectivity standards, the probability of HCV transmission by blood transfusion could be estimated. This knowledge is a necessary component for comparing the efficacy of serologic testing and ID‐NAT in preventing HCV transmission risk, as has been done using data from an international surveillance study …”

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confidence: 99%

Viremia levels in hepatitis C infection among Egyptian blood donors and implications for transmission risk with different screening scenarios

Ekiaby¹,

Moftah

Goubran

et al. 2015

Transfusion

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BACKGROUND Knowledge about the viral load (VL) distributions in different stages of hepatitis C virus (HCV) infection is essential to compare the efficacy of serologic screening and nucleic acid testing (NAT) in preventing transfusion transmission risk. We studied HCV‐RNA levels in Egyptian blood donors in the preseroconversion window period (WP) and in later anti‐HCV–positive stages of infection. STUDY DESIGN AND METHODS Subsets of individual‐donation (ID)‐NAT and anti‐HCV–yield samples from a screening study among 119,756 donors were tested for VL by quantitative polymerase chain reaction (qPCR). Low viremia levels below the quantification limit of qPCR were determined by probit analysis using the proportion of reactive results on replicate NATs. Poisson distribution statistics were used to estimate transmission risk in different stages of HCV infection based on 50% minimum infectious doses (MID50) of 3.2 (1‐10) and 316 (100‐1000) virions in the absence and presence of anti‐HCV, respectively. RESULTS Rates of total HCV infections and WP‐NAT–yield donations in two Egyptian blood centers varied between 2.6% to 4.5% and 1:3100 to 1:9500, respectively. VLs ranged from 82 to 3 × 107 copies/mL in WP and from fewer than 1600 to 1.6 × 106 copies/mL in anti‐HCV–positive carrier donations. Only two (1.1%) of 175 donors with probable resolved infection had detectable RNA on replicate testing (estimated VLs of 0.5 and 1.8 copies/mL). This translates to an estimated transmission risk of 0.028% if ID‐NAT‐nonreactive, anti‐HCV–positive donations would be used for RBC transfusions. CONCLUSION Almost 99% of anti‐HCV–reactive donations without detectable HCV‐RNA on initial ID‐NAT screening had eradicated the virus from the circulation, while 1% had extremely low VLs and are likely not infectious. The incremental safety offered by serologic testing of ID‐NAT–screened blood seems minimal.

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“…They argue that the cause of such questionable results is due to FP IR-NAT, OBI, or window-period donations. In a study performed on Polish donors, it was shown that from 9,980 first-time donors, the IR rate with the Ultrio Plus assay on the Tigris was 0.85, and 0.63% were RR whereas 0.22% were non-RR, and the calculated specificity of initial screening result lay around 99.77% [10]. These authors calculated a 100% specificity with a triplicate ID NAT repeat-testing strategy to eliminate discriminatory tests on false non-RR anti-HBc nonreactive donations.…”

Section: Discussionmentioning

confidence: 99%

“…For this reason, many testing centers have a policy to not use IR donations for transfusion, even though it is known that the vast majority of these donations are FP. This can lead to the loss of valuable donations and needless donor deferrals, so many testing centers around the world including ours have now implemented replicate (duplicate, triplicate, or greater) repeat test strategies on the primary screening tube or sometimes from the fresh frozen plasma (FFP) collected from respective donations [5, 10]. This replicate repeat testing helps to identify low-viral-load samples which may be below the sensitivity limit of the quantitative NAT assays often used for confirmation.…”

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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Head‐to‐head comparison of two transcription‐mediated amplification assay versions for detection of hepatitis B virus, hepatitis C virus, and human immunodeficiency virus Type 1 in blood donors

Cited by 34 publications

References 27 publications

Relative efficacy of nucleic acid amplification testing and serologic screening in preventing hepatitis C virus transmission risk in seven international regions

Relative efficacy of nucleic acid amplification testing and serologic screening in preventing hepatitis C virus transmission risk in seven international regions

Viremia levels in hepatitis C infection among Egyptian blood donors and implications for transmission risk with different screening scenarios

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

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