Hepatitis B Surface Antigen (HBsAg) Assays—Are They Good Enough for Their Current Uses?

Dufour, D Robert

doi:10.1373/clinchem.2006.072504

Cited by 28 publications

(26 citation statements)

References 18 publications

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“…Most screening assays use a pre-determined cut-off value that is designed to achieve high sensitivity for the detection of HBsAg in serum while at the same time minimizing the risk of false-positive results [Dufour, 2006]. All HBsAg assays carry some risk of false-positive results on initial testing, and this was seen in the present study, albeit at a very low level.…”

Section: Discussionmentioning

confidence: 59%

Comparison of the technical and clinical performance of the Elecsys® HBsAg II assay with the Architect®, AxSym®, and Advia® Centaur HBsAg screening assays

Louisirirotchanakul

Khupulsup

Akraekthalin

et al. 2010

Journal of Medical Virology

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South East Asia has some of the highest prevalence rates of hepatitis B virus (HBV) infection (>or=8%) in the world, and the emergence of hepatitis B surface antigen (HBsAg) mutant strains is a growing problem. Assays with the highest levels of sensitivity, including mutant detection, should be used for routine HBsAg screening. In this large multicenter study, the clinical and technical performance of the fully automated Elecsys HBsAg II assay was compared with the Architect, AxSYM, and Advia Centaur HBsAg assays for HBsAg screening. Nine laboratories (three each from Thailand, Korea, and Singapore) compared the Elecsys HBsAg II assay with their routine HBsAg screening assay against a range of stored and routine clinical samples, including recombinant mutants. The Elecsys HBsAg II assay demonstrated equivalent sensitivity and specificity to the Architect HBsAg assay. However, the Elecsys HBsAg II assay recognized a native mutant sample (L94S, L97V, L98V, T123A) that the Architect HBsAg assay failed to detect. The AxSYM and Advia Centaur HBsAg assays appeared less sensitive for the detection of early HBV infection and also failed to detect some of the recombinant mutant strains. There was almost complete agreement between the Elecsys HBsAg II assay and comparator assays with respect to routine serum samples. The results of this study demonstrate that the Elecsys HBsAg II assay is a highly sensitive and specific screening assay for HBsAg and detects reliably the most important and clinically relevant HBV mutants and genotypes. It is suitable for routine HBsAg screening in Asia.

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Section: Discussionmentioning

confidence: 59%

Comparison of the technical and clinical performance of the Elecsys® HBsAg II assay with the Architect®, AxSym®, and Advia® Centaur HBsAg screening assays

Louisirirotchanakul

Khupulsup

Akraekthalin

et al. 2010

Journal of Medical Virology

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“…Although the specificity of the EIA tests used during HBsAg screening is nearly 100%, there was a need to confirm the positive results with a neutralization test, particularly in communities with a low prevalence of Hepatitis B, such as voluntary blood donors. 13,14 In a study recently conducted in Turkey, nearly 70% of the weak positive HBsAg results (with a S/CO ratio between 1 and 2.5) were determined to be negative (false positive) in the confirmatory neutralization tests. 15 Another study found the false positivity rate in weak positive samples to be significantly higher than those of the strong positive samples and recommended that confirmatory tests should only be performed on weakly positive samples.…”

Section: Hivmentioning

confidence: 99%

HBV, HCV and HIV seroprevalence among blood donors in Istanbul, Turkey: how effective are the changes in the national blood transfusion policies?

Acar

Kemahlı

Altunay³

et al. 2010

Braz J Infect Dis

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The national blood transfusion policies have been changed significantly in recent years in Turkey. The purpose of this study was to determine the prevalence of HBV, HCV, and HIV in blood donors at the Red Crescent Center in Istanbul and to evaluate the effect of changes in the national blood transfusion policies on the prevalence of these infections. The screening results of 72695 blood donations at the Red Crescent Center in Istanbul between January and December 2007 were evaluated retrospectively. HBsAg, anti-HCV, and anti-HIV-1/2 were screened by microparticle enzyme immunoassay (MEIA) method. Samples found to be positive for anti-HIV 1/2 and anti-HCV were confirmed by Inno-Lia HCV Ab III and Inno-Lia HIV I/II Score, respectively. The seropositivity rates for HBsAg, anti-HCV, and anti-HIV-1/2 were determined as 1.76%, 0.07%, and 0.008%, respectively. Compared to the previously published data from Red Crescent Centers in Turkey, it was found that HBV and HCV seroprevalances decreased and HIV seroprevalance increased in recent years. In conclusion, we believe that the drop in HBV and HCV prevalence rates are likely multifactorial and may have resulted from more diligent donor questioning upon screening, a higher level of public awareness on viral hepatitis as well as the expansion of HBV vaccination coverage in Turkey. Another factor to contribute to the decreased prevalence of HCV stems from the use of more sensitive confirmation testing on all reactive results, thereby eliminating a fair amount of false positive cases. Despite similar transmission routes, the increase in HIV prevalence in contrast to HBV and HCV may be linked to the increase in AIDS cases in Turkey in recent years

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“…Despite the introduction of universal vaccination and the development of sensitive and specific assays that in recent decades have reduced the risk of infection, HBV seronegative donors may still transmit the virus in the late phase of infection [38]. It is extremely important to determine the prevalence of OHB among healthy blood donors to assess the likelihood of transmission of HBV through blood transfusion, and then assess the need to improve and even modify donor pre-selection strategies to reduce the risk of transmission [18]. Therefore, molecular methods have been used for several years for the selection of a donor blood in the United States and a number of European countries.…”

Section: Introductionmentioning

confidence: 99%

RESULTS OF GENOTYPING HEPATITIS VIRUS B IN HBsAg-NEGATIVE BLOOD DONORS IN ASTANA, KAZAKHSTAN

Ostankova

Семенов

Буркитбаев

et al. 2018

Russian Journal of Infection and Immunity

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Abstract. The prevalence of HBV infection is estimated by the frequency of occurrence of HBsAg and varies depending on the geographic region. Chronic infection is characterized by a stable presence of HBsAg for 6 months, with the exception of the occult form of the disease, characterized by the absence of HBsAg, an extremely low level of HBV DNA in the blood serum. The problem of identifying occult HBV (ocHBV) is especially relevant because of the development of transplantology and transfusiology. However, serological screening of donor blood used in the Russian Federation and Central Asian countries does not reveal HBV seronegative donors. Since HBV infection is possible with the introduction of small doses of the virus, the importance of using complex molecular methods for detecting donor ocHBV is obvious, despite the low viral load, since donor blood is used predominantly in patients with severe course of various diseases characterized by increased susceptibility to HBV because of immunosuppression. The aim of our work was to study the characteristics of the genetic structure of the ocHBV in donors in Astana, Kazakhstan. A total of 500 blood plasma samples from HBsAg-negative donors were obtained in 2012 from residents of Kazakhstan, Astana. Using the method, we proposed to detect HBV DNA with a low viral load, HBV was detected in 9.4% of donors. Serological markers were found in 12.7% of patients with HBV DNA, 8.5% had HBcor IgG antibodies, 4.2% had HBcor IgG and HBe IgG antibodies at the same time. Thus, in 41 (87.3%) of the blood donor, ocHBV was seronegative. Based on the phylogenetic analysis of the 47 isolates showed that the HBV of genotype D (95.75%) prevails in the examined group in comparison with HBV of genotype A (4.25%). HBV subgenotypes are represented in the following ratios: D1 -46.8%, D2 -17.05%, D3 -31.9%, A2 -4.25%. In a comparative analysis, the distribution of HBV subgenotypes in the group with ocHBV and in the case of the manifest form in donors in the Republic of Kazakhstan significantly differed -χ 2 = 14.027 at p = 0.0072, d f = 4. The incidence of HBV D3 with ocHBV (31.9%) exceeded that of patients with a manifest form (7.4%). The relative risk of occult form of disease in patients with the subgenotype D3 is significantly higher (RR = 1.572, CI: 1.179-2.096, p = 0.0208). When assessing the picture of HBV diversity on the material of the group including HBsAg-negative and HBsAg-positive blood donors, it is evident that the genetic relationship of the manifestations of the manifest HBV and the ocHBV of genotype D is obvious. Among the isolates are both similar in nucleotide sequences with those previously described in various regions of Europe and Central Asia, and circulating in the territory of the Republic of Kazakhstan, which indicates an independent homologous evolution of HBV in the region. The high incidence of ocHBV among HBsAg-negative blood donors is indicative not only of the widespread prevalence of the occult form of the disease course in the population and the inadequacy ...

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Hepatitis B Surface Antigen (HBsAg) Assays—Are They Good Enough for Their Current Uses?

Cited by 28 publications

References 18 publications

Comparison of the technical and clinical performance of the Elecsys® HBsAg II assay with the Architect®, AxSym®, and Advia® Centaur HBsAg screening assays

Comparison of the technical and clinical performance of the Elecsys® HBsAg II assay with the Architect®, AxSym®, and Advia® Centaur HBsAg screening assays

HBV, HCV and HIV seroprevalence among blood donors in Istanbul, Turkey: how effective are the changes in the national blood transfusion policies?

RESULTS OF GENOTYPING HEPATITIS VIRUS B IN HBsAg-NEGATIVE BLOOD DONORS IN ASTANA, KAZAKHSTAN

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