An international collaborative study to establish the 2<sup>nd</sup> World Health Organization International Standard for hepatitis B virus DNA nucleic acid amplification technology‐based assays

Baylis, Sally A.; Heath, Alan; Chudy, M.; Pisani, Giulio; Klotz, Andreas; Kerby, Stephen; Gerlich, Wolfram H.

doi:10.1111/j.1423-0410.2008.01023.x

Cited by 29 publications

(15 citation statements)

References 9 publications

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“…Thermal profile was set according to manufacturer's guideline. Detection limit of HBV DNA in the current study assay is 3.8 IU/mL assessed by the World Health Organization (WHO) international standard (97/750) [20] . At least two negative controls, one non template control, and four standards (provided by the manufacturer) were added per run.…”

Section: Molecular Assaysmentioning

confidence: 99%

Occult hepatitis B virus infection among Egyptian blood donors

Said

Sayed²,

Salama

et al. 2013

WJH

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AIM:To identify blood donors with occult hepatitis B virus (HBV) infection (OBI) to promote safe blood donation. METHODS:Descriptive cross sectional study was conducted on 3167 blood donors negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) and human immunodeficiency virus Ab. They were subjected to the detection of alanine aminotransferase (ALT) and aspartate transaminase (AST) and screening for anti-HBV core antibodies (total) by two different techniques; [Monoliza antibodies to hepatitis B core (Anti-HBc) Plus-Bio-Rad] and (ARC-HBc total-ABBOT). Positive samples were subjected to quantitative detection of antibodies to hepatitis B surface (anti-HBs) (ETI-AB-AUK-3, Dia Sorin-Italy). Serum anti-HBs titers > 10 IU/L was considered positive. Quantitative HBV DNA by real time polymerase chain reaction (PCR) (QIAGEN-Germany) with 3.8 IU/mL detection limit was estimated for blood units with negative serum anti-HBs and also for 32 whose anti-HBs serum titers were > 1000 IU/L. Also, 265 recipients were included, 34 of whom were followed up for 3-6 mo. Recipients were investigated for ALT and AST, HBV serological markers: HBsAg (ETI-MAK-4, Dia Sorin-Italy), anti-HBc, quantitative detection of anti-HBs and HBV-DNA. RESULTS: 525/3167 (16.6%) of blood units were positive for total anti-HBc, 64% of those were antiHBs positive. Confirmation by ARCHITECT anti-HBc assay were carried out for 498/525 anti-HBc positive samples, where 451 (90.6%) confirmed positive. Reactivity for anti-HBc was considered confirmed only if two positive results were obtained for each sample, giving an overall prevalence of 451/3167 (14.2%) for total anti-HBc. HBV DNA was quantified by real time PCR in 52/303 (17.2%) of anti-HBc positive blood donors (viral load range: 5 to 3.5 x 10 5

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Section: Molecular Assaysmentioning

confidence: 99%

Occult hepatitis B virus infection among Egyptian blood donors

Said

Sayed²,

Salama

et al. 2013

WJH

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“…All these were derived from the same plasma of one highly viremic HBV carrier. 8,9 HBV strains from different regions of the world differ in their genomic sequence. Eight HBV genotypes (A-H) have been defined so far with >8% intergenotype nucleotide divergence over the entire viral genome.…”

Section: Introductionmentioning

confidence: 99%

“…2. Box plot for panel members(1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15) and the WHO IS (IS) (quantitative assays).…”

mentioning

confidence: 99%

First WHO International Reference Panel containing hepatitis B virus genotypes A–G for assays of the viral DNA

Chudy

Hanschmann

Kreß

et al. 2012

Journal of Clinical Virology

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“…This approach has been followed for the different WHO ISs for HBV DNA using the Eurohep material as common stock. Suitable replacement preparations are typically characterized by low variation of absolute as well as relative potency when compared against the predecessor by using different assays and technologies [23,30,31,32]. In some cases, potential candidate replacement preparations will already have been characterized in the collaborative study where the original IS was established.…”

Section: Who International Standardsmentioning

confidence: 99%

Standardization of NAT for Blood-Borne Pathogens

Baylis

Chudy

Nübling

2015

Transfus Med Hemother

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Assays based on nucleic acid amplification technology (NAT) are increasingly used for screening of blood and for diagnosis or monitoring of patients. Both regulatory requirements for blood screening and international recommendations for the treatment of patients are based on common reference materials available globally for the standardization of NAT assays. World Health Organization International Standards (WHO ISs) and International Reference Panels (WHO IRPs) are primary reference materials. The characterization and manufacture of WHO reference materials as well as their evaluation is performed on behalf of the WHO by collaborating centers; their establishment is decided upon by the WHO Expert Committee on Biological Standardization (ECBS). The potency of the first WHO IS is defined by the ‘international unit' (IU) which should be maintained upon replacement of the IS. The IU, unlike copy number or genome equivalent, is defined by the IS with a physical existence, is available worldwide, and allows traceability and comparability of results. The anticipated use of WHO ISs is the calibration of secondary standards or the validation of essential assay features, e.g. limit of detection.

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An international collaborative study to establish the 2^nd World Health Organization International Standard for hepatitis B virus DNA nucleic acid amplification technology‐based assays

Abstract: On the basis of the data presented in this collaborative study, Sample 2 (code 97/750) was established as the 2nd International Standard for hepatitis B virus DNA for NAT-based assays with a potency of 10(6) IU/ml (500,000 IU/vial).

Cited by 29 publications

References 9 publications

Occult hepatitis B virus infection among Egyptian blood donors

Occult hepatitis B virus infection among Egyptian blood donors

First WHO International Reference Panel containing hepatitis B virus genotypes A–G for assays of the viral DNA

Standardization of NAT for Blood-Borne Pathogens

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An international collaborative study to establish the 2nd World Health Organization International Standard for hepatitis B virus DNA nucleic acid amplification technology‐based assays

Abstract: On the basis of the data presented in this collaborative study, Sample 2 (code 97/750) was established as the 2nd International Standard for hepatitis B virus DNA for NAT-based assays with a potency of 10(6) IU/ml (500,000 IU/vial).

Cited by 29 publications

References 9 publications

Occult hepatitis B virus infection among Egyptian blood donors

Occult hepatitis B virus infection among Egyptian blood donors

First WHO International Reference Panel containing hepatitis B virus genotypes A–G for assays of the viral DNA

Standardization of NAT for Blood-Borne Pathogens

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Product

Resources

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An international collaborative study to establish the 2^nd World Health Organization International Standard for hepatitis B virus DNA nucleic acid amplification technology‐based assays