Evaluation of the highly sensitive chemiluminescent enzyme immunoassay “Lumipulse <scp>HB</scp>sAg‐<scp>HQ</scp>” for hepatitis B virus screening

Deguchi, Masashi; Kagita, Masanori; Yoshioka, Nori; Tsukamoto, Hiroko; Takao, Miyuki; Tahara, Kazuko; Maeda, Ichiro; Hidaka, Yoh; Yamauchi, Satoshi; Kaneko, Atsushi; Miyakoshi, Hideo; Isomura, Mitsuo

doi:10.1002/jcla.22334

Cited by 31 publications

(27 citation statements)

References 14 publications

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“…[45][46][47] Besides sensitivity, commercial HBsAg assays differ in their ability to detect S-escape variants. 45,[48][49][50] The use of anti-HBs probes targeting multiple epitopes of HBsAg should be mandatory for all HBsAg assays to ensure the detection of HBV S variants.…”

Section: Virology and Immunologymentioning

confidence: 99%

Update of the statements on biology and clinical impact of occult hepatitis B virus infection

Raimondo

Locarnini

Pollicino

et al. 2019

Journal of Hepatology

408

498

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In October 2018 a large number of international experts with complementary expertise came together in Taormina to participate in a workshop on occult hepatitis B virus infection (OBI). The objectives of the workshop were to review the existing knowledge on OBI, to identify issues that require further investigation, to highlight both existing controversies and newly emerging perspectives, and ultimately to update the statements previously agreed in 2008. This paper represents the output from the workshop.

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Section: Virology and Immunologymentioning

confidence: 99%

Update of the statements on biology and clinical impact of occult hepatitis B virus infection

Raimondo

Locarnini

Pollicino

et al. 2019

Journal of Hepatology

408

498

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“…New assays have increased sensitivity (LLOD and LLOQ of ~0.005 IU/mL), but the clinical relevance of low levels of HBsAg (0.005-0.05 IU/mL) is unclear. (22)(23)(24) There are 2 sources of circulating HBsAg, cccDNA and integrated HBV DNA, with the latter suggested to be a more important source of HBsAg in HBeAg-negative patients. (25) The efficacy of new antiviral or immunomodulatory therapies that inhibit or clear cccDNA may not be well-reflected in HBsAg measurement if integrated HBV DNA continues to produce HBsAg-unless antiviral immune responses are restored and hepatocytes capable of producing HBsAg from cccDNA as well as integrated HBV DNA are eliminated.…”

Section: Reliability Of Current Hbsag Assays To Assess Hbv Functionalmentioning

confidence: 99%

Guidance for Design and Endpoints of Clinical Trials in Chronic Hepatitis B—Report From the 2019 EASL‐AASLD HBV Treatment Endpoints Conference

et al. 2020

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Representatives from academia, industry, regulatory agencies, and patient groups convened in March 2019 with the primary goal of developing agreement on chronic hepatitis B virus (HBV) treatment endpoints to guide clinical trials aiming to “cure” HBV. Agreement among the conference participants was reached on some key points. “Functional” but not sterilising cure is achievable and should be defined as sustained HBsAg loss in addition to undetectable HBV DNA 6 months post‐treatment. The primary endpoint of phase III trials should be functional cure; HBsAg loss in ≥30% of patients was suggested as an acceptable rate of response in these trials. Sustained virologic suppression (undetectable serum HBV DNA) without HBsAg loss 6 months after discontinuation of treatment would be an intermediate goal. Demonstrated validity for the prediction of sustained HBsAg loss was considered the most appropriate criterion for the approval of new HBV assays to determine efficacy endpoints. Clinical trials aimed at HBV functional cure should initially focus on patients with HBeAg‐positive or negative chronic hepatitis, who are treatment‐naïve or virally suppressed on nucleos(t)ide analogues. A hepatitis flare associated with an increase in bilirubin or international normalised ratio should prompt temporary or permanent cessation of an investigational treatment. New treatments must be as safe as existing nucleos(t)ide analogues. The primary endpoint for phase III trials for HDV coinfection should be undetectable serum HDV RNA 6 months after stopping treatment. On treatment HDV RNA suppression associated with normalisation of alanine aminotransferase is considered an intermediate goal. In conclusion, regarding HBV “functional cure”, the primary goal is sustained HBsAg loss with undetectable HBV DNA after completion of treatment and the intermediate goal is sustained undetectable HBV DNA without HBsAg loss after stopping treatment.

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“…Recently, an enhanced HBsAg chemiluminescent EIA (HBsAg-HQ) and an ultra-high sensitive HBsAg assay employing a semi-automated immune complex transfer chemiluminescence enzyme technique (ICT-CLEIA) were developed that showed 5 and 0.5 mIU/mL sensitivities, respectively ( 29 , 30 ). These highly sensitive assays were reported to detect HBsAg before HBV DNA in few cases and to possibly reduce the WP to ~14 days ( 30 , 31 ). However, they were developed mainly to monitor HBV reactivation in treated patients, and their suitability regarding blood donor screening has not been evaluated so far.…”

Section: Hbsag 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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Evaluation of the highly sensitive chemiluminescent enzyme immunoassay “Lumipulse HBsAg‐HQ” for hepatitis B virus screening

Abstract: According to these results, the Lumipulse HBsAg-HQ assay, with a highly sensitive limit of detection of 0.005 IU/mL, may facilitate the development of a better management strategy for a considerable proportion of infected patients.

Cited by 31 publications

References 14 publications

Update of the statements on biology and clinical impact of occult hepatitis B virus infection

Update of the statements on biology and clinical impact of occult hepatitis B virus infection

Guidance for Design and Endpoints of Clinical Trials in Chronic Hepatitis B—Report From the 2019 EASL‐AASLD HBV Treatment Endpoints Conference

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

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