The yield of universal antibody to hepatitis B core antigen donor screening in the<scp>N</scp>etherlands, a hepatitis B virus low‐endemic country

Laar, Thijs J. van de; Kreek, Tanneke Marijt-van der; Backer, Marijke W. Molenaar‐de; Hogema, Boris M.; Zaaijer, Hans L.

doi:10.1111/trf.12962

Cited by 28 publications

(23 citation statements)

References 34 publications

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“…Though anti-HBc reactivity alone does not necessarily indicate a high likelihood of infection transmission, especially in the absence of other markers of HBV disease, and screening for anti-HBc is considered an added precaution for a safer blood product [20], this study recommends that blood banks screening for anti-HBc must either design or adopt previously published algorithms [20,21], which would enable these banks to re-qualify anti-HBc positive donors for blood donation, thus reducing donor loss whilst trying to ensure the safety of blood and blood products [22].…”

Section: Discussionmentioning

confidence: 99%

Seroprevalence rates of transfusion-transmitted infections among blood donors in Jordan

Souan

Tout

Siag

et al. 2016

J Infect Dev Ctries

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Introduction: Statistics on the prevalence of donor screening for hepatitis B surface antigen (HBsAg) and anti-hepatitis C virus (anti-HCV) in Jordan are outdated. There are no studies on the prevalence of anti-HIV I/II, anti-human T-cell lymphotropic virus type I and II (anti-HTLV-I/II), or anti-syphilis. Data are also lacking on the prevalence and significance of using anti-HBc screening in Jordan. This study aimed to evaluate the prevalence of transfusion-transmissible infections (TTI) among donors at King Hussein Cancer Center and compare it with neighboring countries and to evaluate the significance of screening for anti-HB core total (anti-HBc) antibodies. Methodology: A retrospective analysis covering the period from 2009 to 2013 was conducted on records of healthy donors. The number of donors was 10,101, 12,694, 13,387, 14,256, and 12,495, respectively. Donors were screened for HBsAg, anti-HBc, anti-HIV I/II, anti-HCV, and anti-HTLV-I/II using ELISA technique, while syphilis antibodies were detected using rapid chromatographic immunoassay. Results: Among 62,933 donors, the prevalence of HBsAg was 0.52%, of anti-HBc was 6.04%, and of anti-HCV was 0.16%. None of the donors were positive for anti-HIV I/II, anti-HTLV I/II, or anti-TP. Conclusions: This study demonstrates that the seroprevalence for HBsAg, anti-HBc, and anti-HCV in Jordan was low compared to neighboring countries. None of the donors were confirmed positive for anti-HIV I/II, anti-HTLV I/II, or anti-TP during the studied period. This study demonstrates the importance of screening for anti-HBc to improve blood and platelet safety and stresses the need to complement it with an algorithm that qualifies reentry of anti-HBc false-positive donors.

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Section: Discussionmentioning

confidence: 99%

Seroprevalence rates of transfusion-transmitted infections among blood donors in Jordan

Souan

Tout

Siag

et al. 2016

J Infect Dev Ctries

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“…It is generally admitted that deferring anti-HBc reactive units would too severely affect blood supply and at a non-affordable cost in medium- and high-endemic areas where anti-HBc prevalence in blood donors ranges between 8 and >50% (i.e., Mediterranean area, East Asia, and sub-Saharan Africa). By contrast, the donor loss caused by universal anti-HBc screening was considered sustainable in some medium/low-endemic countries including Canada, France, Germany, Ireland, the Netherlands, Lebanon, and USA ( 60 , 61 ). To limit potential donor loss associated with a ~5% anti-HBc prevalence, Japan implemented a complex screening algorithm that includes anti-HBs testing of anti-HBc only donations ( 56 ).…”

Section: Anti-hbc Testingmentioning

confidence: 99%

Hepatitis B Virus Blood Screening: Need for Reappraisal of Blood Safety Measures?

Candotti

Laperche

2018

Front. Med.

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Over the past decades, the risk of HBV transfusion–transmission has been steadily reduced through the recruitment of volunteer donors, the selection of donors based on risk-behavior evaluation, the development of increasingly more sensitive hepatitis B antigen (HBsAg) assays, the use of hepatitis B core antibody (anti-HBc) screening in some low-endemic countries, and the recent implementation of HBV nucleic acid testing (NAT). Despite this accumulation of blood safety measures, the desirable zero risk goal has yet to be achieved. The residual risk of HBV transfusion–transmission appears associated with the preseroconversion window period and occult HBV infection characterized by the absence of detectable HBsAg and extremely low levels of HBV DNA. Infected donations tested false-negative with serology and/or NAT still persist and derived blood components were shown to transmit the virus, although rarely. Questions regarding the apparent redundancy of some safety measures prompted debates on how to reduce the cost of HBV blood screening. In particular, accumulating data strongly suggests that HBsAg testing may add little, if any HBV risk reduction value when HBV NAT and anti-HBc screening also apply. Absence or minimal acceptable infectious risk needs to be assessed before considering discontinuing HBsAg. Nevertheless, HBsAg remains essential in high-endemic settings where anti-HBc testing cannot be implemented without compromising blood availability. HBV screening strategy should be decided according to local epidemiology, estimate of the infectious risk, and resources.

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“…In some HBV lowprevalence countries, donor screening with anti-HBc is used to interdict donors at risk for OBI. 17,28,31 In higherprevalence settings, exclusion of donations containing anti-HBc would not be feasible. In these settings, the choice between IDT NAT and MP NAT for detection of OBI involves consideration of OBI prevalence, balancing of NAT sensitivity versus specificity, throughput, and cost.…”

Section: Discussionmentioning

confidence: 99%

Sensitivity and specificity of a new automated system for the detection of hepatitis B virus, hepatitis C virus, and human immunodeficiency virus nucleic acid in blood and plasma donations

Galel

Simon²,

Williamson³

et al. 2017

Transfusion

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BACKGROUND: Use of nucleic acid testing (NAT) in donor infectious disease screening improves transfusion safety. Advances in NAT technology include improvements in assay sensitivity and system automation, and real-time viral target discrimination in multiplex assays. This article describes the sensitivity and specificity of cobas MPX, a multiplex assay for detection of human immunodeficiency virus (HIV)-1 Group M, HIV-2 and HIV-1 Group O RNA, HCV RNA, and HBV DNA, for use on the cobas 6800/8800 Systems. STUDY DESIGN AND METHODS:The specificity of cobas MPX was evaluated in samples from donors of blood and source plasma in the United States. Analytic sensitivity was determined with reference standards. Infectious window periods (WPs) before NAT detectability were calculated for current donor screening assays. RESULTS:The specificity of cobas MPX was 99.946% (99.883%-99.980%) in 11,203 blood donor samples tested individually (IDT), 100% (99.994%-100%) in 63,012 donor samples tested in pools of 6, and 99.994% (99.988%-99.998%) in 108,306 source plasma donations tested in pools of 96. Seven HCV NAT-yield donations and one seronegative occult HBV infection were detected. Ninety-five percent and 50% detection limits in plasma (IU/mL) were 25.7 and 3.8 for HIV-1M, 7.0 and 1.3 for HCV, and 1.4 and 0.3 for HBV. The HBV WP was 1 to 4 days shorter than other donor screening assays by IDT. CONCLUSION: cobas MPX demonstrated high specificity in blood and source plasma donations tested individually and in pools. High sensitivity, in particular for HBV, shortens the WP and may enhance detection of occult HBV. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. ABBREVIATIONS: CASThe studies described in this article were sponsored by Roche Molecular Systems, Inc.Received for publication May 25, 2017; revision received November 13, 2017; and accepted November 17, 2017. doi:10.1111/trf.14457 (HIV, HBV, or HCV) during the primary multiplex screen, eliminating the need for a second round of discriminatory testing.Assays used for testing blood donations require a high level of sensitivity to assure detection of infectious blood units but at the same time must also have high specificity to avoid wastage of safe donations and unnecessary donor deferral. The cobas MPX test for use on the cobas 6800/8800 Systems (Roche Molecular Systems, Inc.[RMS]) is a qualitative in vitro nucleic acid screening test (NAT) for the direct detection of HIV Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, HIV Type 2 (HIV-2) RNA, HCV RNA, and HBV DNA in human plasma and serum. Results are simultaneously detected and discriminated for HIV, HCV, and HBV. This article describes the results of preclinical and clinical performance studies evaluating the sensitivity and specificity of this new donor screening test. MATERIALS AND METHODS Assays and syste...

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The yield of universal antibody to hepatitis B core antigen donor screening in theNetherlands, a hepatitis B virus low‐endemic country

Cited by 28 publications

References 34 publications

Seroprevalence rates of transfusion-transmitted infections among blood donors in Jordan

Seroprevalence rates of transfusion-transmitted infections among blood donors in Jordan

Hepatitis B Virus Blood Screening: Need for Reappraisal of Blood Safety Measures?

Sensitivity and specificity of a new automated system for the detection of hepatitis B virus, hepatitis C virus, and human immunodeficiency virus nucleic acid in blood and plasma donations

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