A multicentre assessment of the specificity of ten anti‐HBc screening tests

Hughes, Walter T.; Barr, A.; Dow, B. C.; Follett, E. A. C.; Barbara, J. A. J.

doi:10.1111/j.1365-3148.1995.tb00232.x

Cited by 31 publications

(19 citation statements)

References 17 publications

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“…These 6 donors had to be temporarily deferred. Fortunately, this number of false-positive results is lower than expected from data previously reported by Hughes et al [20] and certainly is due to improved and more specific test systems. In this respect, both tests showed a comparably high specificity which is supposed to be sufficient for the screening of a low-prevalence population.…”

Section: Discussioncontrasting

confidence: 51%

Introducing Anti-HBc Screening in Germany – Possible Implications for the Blood Donation Service

Zeiler

Karger

Slonka

et al. 2006

Transfus Med Hemother

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The German National Advisory Committee ‘Blood’ (Arbeitskreis Blut), recently recommended testing of blood and plasma donations for antibodies against the hepatitis B core antigen (anti-HBc). We assessed possible effects of this intended measure on donor deferral rate and look back procedures. Study Design and Methods: 3,964 consecutive blood donors were tested for anti-HBc for the first time. Anti-HBc-positive samples were further investigated employing an alternative anti-HBc test, quantitative determination of anti-HBs and HBV nucleic acid testing. Results: 46 (1.16%) of the samples were tested specifically anti-HBc-positive. Following the recommendations of the Arbeitskreis Blut, 9 (0.23% of all) donors had to be permanently deferred. Eight of these were repeat donors and had already donated 353 blood components which had been transfused to 285 recipients during the past 17 years. Conclusions: Implementation of anti-HBc testing in Germany will result in an acceptable loss of blood donors. However, the realization of look-back procedures is problematic due to the huge number of transfused blood components, the long period of time those donors gave blood, and particularly the impossibility to precisely determine the time of seroconversion. Therefore, when introducing anti-HBc testing, regulatory authorities should consider the described implications for look-back procedures.

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Section: Discussioncontrasting

confidence: 51%

Introducing Anti-HBc Screening in Germany – Possible Implications for the Blood Donation Service

Zeiler

Karger

Slonka

et al. 2006

Transfus Med Hemother

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“…Testing for anti-HBc contributed at that time to the reduction in the number of post-transfusion hepatitis B cases in these countries 39,40. On the other hand, in HBV low-prevalence countries, a large proportion of the anti-HBc reactive blood donations may be false reactive, due to the lack of specificity of the available assays 41–43. The reason for this lies within the original development of anti-HBc tests.…”

Section: Anti-hbc Testingmentioning

confidence: 99%

Reducing the risk of hepatitis B virus transfusion-transmitted infection

Niederhauser

2011

JBM

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Before 1970, approximately 6% of multi-transfused recipients acquired a transfusion-transmitted Hepatitis B virus (HBV) infection. The safety improvements since then have been tremendous. From a level of a few infections per 1000 donations, the risk today, depending on the screening algorithm and additional measurements performed, has decreased to around 1:500,000 to 1:1,000,000, an improvement greater than 1000-fold compared to 50 years ago. This enormous gain in safety has been achieved through many factors, including development of increasingly more sensitive Hepatitis B antigen (HBsAg) assays; the adoption in some countries of hepatitis B core antibody (anti-HBc) screening; an improved donor selection procedure; HBV vaccination programs; and finally the introduction of HBV nucleic acid testing (NAT). Because there is a tendency in transfusion medicine to add one safety measure on top of another to approach the ultimate goal of zero risks, costs become increasingly a matter of debate. It is obvious that any new measure in addition to existing methods or measures will have very poor cost effectiveness. Therefore each country needs to perform its own calculation based on the country’s own epidemiology, resources, political and public awareness of the risks, in order to choose the correct and most cost-efficient measures. Ideally, each country would make decisions regarding implementation of additional blood safety measures in the context of both the perceived benefit and the allocation of overall health care resources.

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“…Gomes et al (1996) demonstrated that samples presenting isolated anti-HBc as well as anti-HBc/anti-HBs contain HBV-DNA at a very low concentration, close to the limit of detection. Moreover, the occurrence of false anti-HBc positivity was reported by Douglas et al (1993) and Hughes et al (1995).…”

mentioning

confidence: 98%