Development and clinical validation of loop-mediated isothermal amplification (LAMP) assay to diagnose high HBV DNA levels in resource-limited settings

Vanhomwegen, Jessica; Kwasiborski, Aurélia; Diop, A.; Boizeau, Laure; Hoinard, Damien; Vray, Muriel; Bercion, Raymond; Ndiaye, Bara; Dublineau, Amélie; Michiyuki, Satoru; Manuguerra, Jean-Claude; Sauvage, Virginie; Candotti, Daniel; Seck, Abdoulaye; Laperche, Syria; Shimakawa, Yusuke

doi:10.1016/j.cmi.2021.03.014

Cited by 21 publications

(11 citation statements)

References 23 publications

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“…All the above findings highlight the need to develop alternative monitoring algorithms adapted to supply and demand constraints at the health system’s decentralized level. For example, by measuring HBV DNA at the initial examination and then only when transaminases levels are abnormal, by using alternative methods to quantify HBV DNA levels, ( 30 , 31 ) or by adapting the frequency of follow‐up (depending on whether HBV infection is active or inactive). Moreover, ensuring that people have access to HBV care and treatment according to their financial means is vital for the scaling up of care and treatment.…”

Section: Discussionmentioning

confidence: 99%

Hepatitis B in Senegal: A Successful Infant Vaccination Program but Urgent Need to Scale Up Screening and Treatment (ANRS 12356 AmBASS survey)

et al. 2021

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Senegal introduced the infant hepatitis B virus (HBV) vaccination in 2004 and recently committed to eliminating hepatitis B by 2030. Updated epidemiological data are needed to provide information on the progress being made and to develop new interventions. We estimated the prevalence of hepatitis B surface antigen (HBsAg) in children and adults living in rural Senegal and assessed hepatitis B treatment eligibility. A cross‐sectional population‐based serosurvey of HBsAg was conducted in 2018‐2019 in a large sample (n = 3,118) of residents living in the Niakhar area (Fatick region, Senegal). Individuals positive for HBsAg subsequently underwent clinical and biological assessments. Data were weighted for age and sex and calibrated to be representative of the area’s population. Among the 3,118 participants, 206 were HBsAg positive (prevalence, 6.9%; 95% confidence interval [CI], 5.6‐8.1). Prevalence varied markedly according to age group in individuals aged 0‐4, 5‐14, 15‐34, and ≥35 years as follows: 0.0% (95% CI, 0.00‐0.01); 1.5% (95% CI, 0.0‐2.3); 12.4% (95% CI, 9.1‐15.6); and 8.8% (95% CI, 6.1‐11.5), respectively. Of those subsequently assessed, 50.9% (95% CI, 41.8‐60.0) had active HBV infection; 4 (2.9%; 95% CI, 0.9‐9.4) were eligible for hepatitis B treatment. Conclusion: In this first population‐based serosurvey targeting children and adults in rural Senegal, HBsAg prevalence was very low in the former, meeting the World Health Organization’s (WHO) < 1% HBsAg 2020 target; however, it was high in young adults (15‐34 years old) born before the HBV vaccine was introduced in 2004. To reach national and WHO hepatitis elimination goals, general population testing (particularly for adolescents and young adults), care, and treatment scale‐up need to be implemented.

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Section: Discussionmentioning

confidence: 99%

Hepatitis B in Senegal: A Successful Infant Vaccination Program but Urgent Need to Scale Up Screening and Treatment (ANRS 12356 AmBASS survey)

et al. 2021

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“…A total of 89 plasma samples (Supplementary Table S1) from blood donors previously screened for HBV DNA by routine nucleic acid testing were obtained from the Etablissement Français du Sang (EFS, Saint-Denis, France). These samples were genotyped and titrated as previously described [31]. The panel included samples from HBV genotypes A (n = 27), B (n = 11), C (n = 7), D (n = 31), E (n = 11), and F (n = 1), and one undefined sample (n = 1).…”

Section: Plasma Samplesmentioning

confidence: 99%

Rapid Diagnostic Test for Hepatitis B Virus Viral Load Based on Recombinase Polymerase Amplification Combined with a Lateral Flow Read-Out

et al. 2022

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Hepatitis B (HBV) infection is a major public health concern. Perinatal transmission of HBV from mother to child represents the main mode of transmission. Despite the existence of effective immunoprophylaxis, the preventive strategy is inefficient in neonates born to mothers with HBV viral loads above 2 × 105 IU/mL. To prevent mother-to-child transmission, it is important to identify highly viremic pregnant women and initiate antiviral therapy to decrease their viral load. We developed a simple innovative molecular approach avoiding the use of automatic devices to screen highly viremic pregnant women. This method includes rapid DNA extraction coupled with an isothermal recombinase polymerase amplification (RPA) combined with direct visual detection on a lateral flow assay (LFA). We applied our RPA-LFA approach to HBV DNA-positive plasma samples with various loads and genotypes. We designed a triage test by adapting the analytical sensitivity to the recommended therapeutic decision threshold of 2 × 105 IU/mL. The sensitivity and specificity were 98.6% (95% CI: 92.7–99.9%) and 88.2% (95% CI: 73.4–95.3%), respectively. This assay performed excellently, with an area under the ROC curve value of 0.99 (95% CI: 0.99–1.00, p < 0.001). This simple method will open new perspectives in the development of point-of-care testing to prevent HBV perinatal transmission.

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“…Therefore, quantification of serum HBV loads and prediction of HCC risk become the prioritized services to be reorganized in time for HBV patients. Recently, rapid and cheap assays of serum HBV titers from limited blood specimens have been developed by simply applying the loop-mediated isothermal amplification or the fluorescence-based polymerase spiral reaction [ 162 , 163 ]. For surveying the HBV patients with the exacerbation probability, the HCC prediction score focusing on the measurement of hepatic fibrosis was recently evaluated in the HBV cohort.…”

Section: The Impact Of Emerging Covid-19 Pandemic On Chb Patientsmentioning

confidence: 99%

Unique Features of Hepatitis B Virus-Related Hepatocellular Carcinoma in Pathogenesis and Clinical Significance

Wang

Yeh

Chen

2021

Cancers

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Hepatitis B virus (HBV) infection is one of the important risk factors for hepatocellular carcinoma (HCC) worldwide, accounting for around 50% of cases. Chronic hepatitis B infection generates an inflammatory microenvironment, in which hepatocytes undergoing repeated cycles of damage and regeneration accumulate genetic mutations predisposing them to cancer. A striking male dominance in HBV-related HCC highlights the influence of sex hormones which interact with viral factors to influence carcinogenesis. HBV is also considered an oncogenic virus since its X and surface mutant proteins showed tumorigenic activity in mouse models. The other unique mechanism is the insertional mutagenesis by integration of HBV genome into hepatocyte chromosomes to activate oncogenes. HCC survival largely depends on tumor stages at diagnosis and effective treatment. However, early diagnosis by the conventional protein biomarkers achieves limited success. A new biomarker, the circulating virus–host chimera DNA from HBV integration sites in HCC, provides a liquid biopsy approach for monitoring the tumor load in the majority of HBV–HCC patients. To maximize the efficacy of new immunotherapies or molecular target therapies, it requires better classification of HCC based on the tumor microenvironment and specific carcinogenic pathways. An in-depth study may benefit both the diagnosis and treatment of HBV-related HCC.

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Development and clinical validation of loop-mediated isothermal amplification (LAMP) assay to diagnose high HBV DNA levels in resource-limited settings

Cited by 21 publications

References 23 publications

Hepatitis B in Senegal: A Successful Infant Vaccination Program but Urgent Need to Scale Up Screening and Treatment (ANRS 12356 AmBASS survey)

Hepatitis B in Senegal: A Successful Infant Vaccination Program but Urgent Need to Scale Up Screening and Treatment (ANRS 12356 AmBASS survey)

Rapid Diagnostic Test for Hepatitis B Virus Viral Load Based on Recombinase Polymerase Amplification Combined with a Lateral Flow Read-Out

Unique Features of Hepatitis B Virus-Related Hepatocellular Carcinoma in Pathogenesis and Clinical Significance

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