Detection and identification of occult <scp>HBV</scp> in blood donors in <scp>T</scp>aiwan using a commercial, multiplex, multi‐dye nucleic acid amplification technology screening test

Lin, Kuan-Tsou; Chang, C. L.; Tsai, Mee-Sun; Lin, Kuo‐Sin; Saldanha, J.; Hung, Cheng-Shen

doi:10.1111/vox.12075

Cited by 10 publications

(8 citation statements)

References 28 publications

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“…The prevalence in our study was more than 54-fold higher than the average prevalence in the international survey in 200817. In Taiwan, the prevalence was 1/747, which was higher than that of our study18. The difference may be due to the difference in prevalence of HBV infection between them.…”

Section: Discussioncontrasting

confidence: 80%

Prevalence of HBV DNA among 20 million seronegative blood donations in China from 2010 to 2015

Liu

Chang

et al. 2016

Sci Rep

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The prevalence of HBV DNA among seronegative blood donations in China has not been studied extensively on a nationwide scale. The aim of this study was to analyse the prevalence, trend, distributions, and serological characteristics of HBV DNA positive/seronegative blood donations. We collected HBV test data from all blood banks of China from 2010 to 2015 and performed supplemental serological tests and quantitative detection of HBV DNA of the seronegative/HBV DNA positive blood donations. We analysed the prevalence of HBV DNA among seronegative blood donations screened by varying nucleotide acid test (NAT) reagents. The analysis results showed that a total of 20,084,187 seronegative blood donations were screened by NAT from 2010 to 2015 in China. The average frequency of HBV DNA among seronegative blood donations was 1/1482, but there has been a steady increase from 1/1861 in 2011 to 1/1269 in 2015. The geographical distribution of seronegative and HBV DNA positive blood donations was roughly consistent with that of HBsAg. The most common serological pattern was HBeAb and HBcAb positive. In conclusion, our study offeres fundamental data of seronegative and HBV DNA positive blood donations throughout China.

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Section: Discussioncontrasting

confidence: 80%

Prevalence of HBV DNA among 20 million seronegative blood donations in China from 2010 to 2015

Liu

Chang

et al. 2016

Sci Rep

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“…To limit costs, NAT screening was done with pooled samples of 6-50 blood donations that, if reactive, are further tested to identify the reactive sample [55][56][57][58][59]. Some assays have been specifically designed to provide the amplification of the viral genome and the identification of reactive samples in only one step [60,61]. Furthermore, it is worth considering that using NAT a significantly higher number of samples can be processed per day and that results are readily available allowing for the release of all blood components, even those with a short half-life such as platelets [62].…”

Section: Detection Of Occult Hepatitis B Infections In Blood Donorsmentioning

confidence: 99%

Occult Hepatitis Infection in Transfusion Medicine: Screening Policy and Assessment of Current Use of Anti-HBc Testing

Esposito

Sabia

Iannone

et al. 2017

Transfus Med Hemother

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HBV still represents a global risk factor in transfusion medicine. The residual risk of HBV is not limited to pre-seroconversion window period but it extends to donors with occult HBV infection (OBI) characterized by the presence of HBV DNA in liver and by the absence of the virus surface antigen. Each country developed an appropriate blood screening policy according to local HBV prevalence, yields of infectious units per different screening methods and cost-effectiveness. We underline the need of maintaining a high level of attention for OBI carrier identification in all blood banks worldwide where the screening procedures are generally based on a combination of both serological markers and nucleic acid amplification test. In this context, markers such as hepatitis B surface antibodies and hepatitis B core antibodies (anti-HBc) might be useful, although the use of this latter is highly debated and still controversial. Our aim is to give an overview on the relevant diagnostic approaches for the routine screening for HBV focusing on the feasibility of anti-HBc testing as precautionary measure in preventing OBI transmission worldwide. In our tailored algorithm, the loss of about 1% of ‘anti-HBc only' donors, does not significantly affect the blood supply while improving recipient safety.

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“…In populations where HBV is prevalent, chronic infection not detected by HBsAg testing (OBI) poses an additional risk to the blood supply . In this setting, HBV NAT sensitivity is particularly important because such infections can be associated with low levels of circulating HBV DNA (<10 IU/mL) . A highly sensitive HBV NAT can produce a high detection rate of OBI, even in small minipools .…”

Section: Discussionmentioning

confidence: 99%

“…22,27 In this setting, HBV NAT sensitivity is particularly important because such infections can be associated with low levels of circulating HBV DNA (<10 IU/mL). 28,29 A highly sensitive HBV NAT can produce a high detection rate of OBI, even in small minipools. 29,30 With cobas MPX one would predict a 50% likelihood of detecting a donation with a viral load of 1.8 IU/mL in a MP6 or 0.3 IU/mL by IDT.…”

Section: Discussionmentioning

confidence: 99%

“…28,29 A highly sensitive HBV NAT can produce a high detection rate of OBI, even in small minipools. 29,30 With cobas MPX one would predict a 50% likelihood of detecting a donation with a viral load of 1.8 IU/mL in a MP6 or 0.3 IU/mL by IDT. In some HBV lowprevalence countries, donor screening with anti-HBc is used to interdict donors at risk for OBI.…”

Section: Discussionmentioning

confidence: 99%

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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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Detection and identification of occult HBV in blood donors in Taiwan using a commercial, multiplex, multi‐dye nucleic acid amplification technology screening test

Cited by 10 publications

References 28 publications

Prevalence of HBV DNA among 20 million seronegative blood donations in China from 2010 to 2015

Prevalence of HBV DNA among 20 million seronegative blood donations in China from 2010 to 2015

Occult Hepatitis Infection in Transfusion Medicine: Screening Policy and Assessment of Current Use of Anti-HBc Testing

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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