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Computer-aided vibrational spectroscopy detection technology has achieved promising results in the field of early disease diagnosis. Yet limited by factors such as the number of actual samples and the cost of spectral acquisition in clinical medicine, the data available for model training are insufficient, and the amount of data varies greatly between different diseases, which constrain the performance optimization and enhancement of the diagnostic model. In this study, vibrational spectroscopy data of three common diseases are selected as research objects, and experimental research is conducted around the class imbalance situation that exists in medical data. When dealing with the challenge of class imbalance in medical vibrational spectroscopy research, it no longer relies on some kind of independent and single method, but considers the combined effect of multiple strategies. SVM, K-Nearest Neighbor (KNN), and Decision Tree (DT) are used as baseline comparison models on Raman spectroscopy medical datasets with different imbalance rates. The performance of the three strategies, Ensemble Learning, Feature Extraction, and Resampling, is verified on the class imbalance dataset by G-mean and AUC metrics, respectively. The results show that all the above three methods mitigate the negative impact caused by unbalanced learning. Based on this, we propose a hybrid ensemble classifier (HEC) that integrates resampling, feature extraction, and ensemble learning to verify the effectiveness of the hybrid learning strategy in solving the class imbalance problem. The G-mean and AUC values of the HEC method are 82.7 % and 83.12 % for the HBV dataset, is 2.02 % and 1.98 % higher than the optimal strategy; 83.62 % and 83.76 % for the HCV dataset, is 9.79 % and 8.47 % higher than the optimal strategy; while for the thyroid dysfunction dataset are 77.56 % and 77.85 %, is 6.92 % and 6.36 % higher than that of the optimal strategy, respectively. The experimental results show that the G-mean and AUC metrics of the HEC method are higher than those of the baseline classifier as well as the optimal combination using separate strategies. It can be seen that the HEC method can effectively counteract the unfavorable effects of imbalance learning and is expected to be applied to a wider range of imbalance scenarios., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier B.V.)

In 2023, the US Centers for Disease Control and Prevention recommended universal screening for hepatitis B virus (HBV); however, the proportion of US adults screened before implementing this recommendation is unknown. We analysed nationally representative data from the National Health Interview Survey (2013-2017) on self-reported HBV testing among noninstitutionalized US adults ≥18 years. We employed Poisson logistic regression to identify factors associated with self-reported testing, using a conceptual framework that included four overarching factors: sociodemographic characteristics, healthcare access, health-seeking behaviours and experiences, and access to internet-based health information. Among 149,628 survey respondents, the self-reported HBV testing rate was 27.2% (95% CI 26.2-28.7) and increased by 1.7% from 2013 to 2017 (p = .006). In adjusted analysis, health-seeking behaviours and experiences had the strongest associations of self-reported testing including a history of hepatitis (AOR 2.68, 95% CI 1.92-3.73), receipt of hepatitis B vaccination (AOR 5.11, 95% CI 4.61-5.68) and prior testing for hepatitis C (AOR 9.14, 95% CI 7.97-10.48) and HIV (AOR 2.69, 95% CI 2.44-2.97). Other factors associated with testing included being male (AOR 1.14, 95% CI 1.03-1.26), ages 30-44 years (AOR 1.37, 95% CI 1.17-1.61), 45-60 years (AOR 1.55, 95% CI 1.30-1.80) and ≥60 years (AOR 1.53, 95% CI 1.28-1.84), residence in the Western US region (AOR 1.23, 95% CI 1.06-1.43), and access to internet-based health information (AOR 1.32, 95% CI 1.18-1.47). Being Hispanic was associated with lower odds of testing (AOR 0.80, 95% CI 0.66-0.97). These findings may help guide optimal HBV screening in the universal testing era., (© 2024 The Author(s). Journal of Viral Hepatitis published by John Wiley & Sons Ltd.)

Introduction and Objectives: The increasing incidence of hepatocellular carcinoma (HCC) in China is an urgent issue, necessitating early diagnosis and treatment. This study aimed to develop personalized predictive models by combining machine learning (ML) technology with a demographic, medical history, and noninvasive biomarker data. These models can enhance the decision-making capabilities of physicians for HCC in hepatitis B virus (HBV)-related cirrhosis patients with low serum alpha-fetoprotein (AFP) levels., Patients and Methods: A total of 6,980 patients treated between January 2012 and December 2018 were included. Pre-treatment laboratory tests and clinical data were obtained. The significant risk factors for HCC were identified, and the relative risk of each variable affecting its diagnosis was calculated using ML and univariate regression analysis. The data set was then randomly partitioned into validation (20 %) and training sets (80 %) to develop the ML models., Results: Twelve independent risk factors for HCC were identified using Gaussian naïve Bayes, extreme gradient boosting (XGBoost), random forest, and least absolute shrinkage and selection operation regression models. Multivariate analysis revealed that male sex, age >60 years, alkaline phosphate >150 U/L, AFP >25 ng/mL, carcinoembryonic antigen >5 ng/mL, and fibrinogen >4 g/L were the risk factors, whereas hypertension, calcium <2.25 mmol/L, potassium ≤3.5 mmol/L, direct bilirubin >6.8 μmol/L, hemoglobin <110 g/L, and glutamic-pyruvic transaminase >40 U/L were the protective factors in HCC patients. Based on these factors, a nomogram was constructed, showing an area under the curve (AUC) of 0.746 (sensitivity = 0.710, specificity=0.646), which was significantly higher than AFP AUC of 0.658 (sensitivity = 0.462, specificity=0.766). Compared with several ML algorithms, the XGBoost model had an AUC of 0.832 (sensitivity = 0.745, specificity=0.766) and an independent validation AUC of 0.829 (sensitivity = 0.766, specificity = 0.737), making it the top-performing model in both sets. The external validation results have proven the accuracy of the XGBoost model., Conclusions: The proposed XGBoost demonstrated a promising ability for individualized prediction of HCC in HBV-related cirrhosis patients with low-level AFP., Competing Interests: Declaration of interests None., (Copyright © 2024 Fundación Clínica Médica Sur, A.C. Published by Elsevier España, S.L.U. All rights reserved.)

Hepatitis B Virus (HBV) infectivity data were reviewed and the 50% infectious dose (ID 50 ) was reassessed in different HBsAg-positive infection stages enabling modelling of transfusion-transmitted (TT)-HBV infection risk if HBsAg donor screening was replaced by individual donation nucleic acid amplification technology (ID-NAT). Quantitative HBsAg and HBV-DNA assays were performed against international standards to compare the ratio between potential infectious HBV virions and subviral HBsAg particles in Egyptian HBsAg-positive blood donors as well as in Japanese chimpanzee samples of known infectivity. HBV-DNA load below the quantification limit of detection was estimated against a reference standard by replicate NAT testing (n = 25). Infectivity of chimpanzee samples collected during ramp-up and declining viremic phase were tested in a human liver chimeric mice (HLCM) model and compared with published infectivity data from different HBsAg-positive infection stages. Lowest estimates of ID 50 in HBsAg-positive plasma were 3-6 HBV virions in chimpanzee studies. Infectivity decreased approximately 10-100-fold in the declining viremic phase using HLCM. In acute phase samples, HBV to HBsAg particle ratios varied between 1:10 2 -10 4 but in HBsAg-positive blood donors this particle ratio reached 1:10 6 -10 12 when viral load was below 100 HBV-DNA copies/mL. Modelled TT-HBV risk of an HBsAg-positive/ID-NAT nonreactive blood transfusion was estimated at 5.5%-27% for components containing 20-200 mL of plasma when assuming an ID 50 of 316 (point estimate between 100 and 1000) virions. It cannot be ensured that discontinuation of HBsAg donor screening and reliance on ID-NAT alone is safe., (© 2024 John Wiley & Sons Ltd.)

Current guidelines recommend reflex testing for hepatitis D virus (HDV) coinfection in hepatitis B surface antigen (HBsAg)-positive patients over risk-factor based screening. We aimed to evaluate the feasibility and diagnostic yield of reflex anti-HDV testing at a Central European tertiary care center. We retrospectively included 560 consecutive patients who had a recorded (first) positive HBsAg test result at the Vienna General Hospital between 2018 and 2022. While reflex anti-HDV testing had been implemented in our hepatitis outpatient clinic (n = 153, 'reflex testing cohort'), HDV screening needed to be manually ordered in the remaining patients (n = 407, 'standard testing cohort'). Overall, 98.0% and 65.1% of patients in the reflex and standard testing cohort were screened for anti-HDV, respectively, and the overall seroprevalence of anti-HDV among screened patients was 6.7% (n = 28, reflex testing cohort: 9.3%, standard testing cohort: 5.3%). Risk factors for HDV were present in 49.1% of all included and in 89.3% of anti-HDV positive patients, respectively. Anti-HDV positive patients showed higher ALT (54 [33-83] vs. 29 [19-49] U/L; p = 0.005) and a higher proportion of low-to-undetectable HBV-DNA (61.5% vs. 33.2%; p < 0.001), as compared to anti-HDV negative patients. HDV-RNA PCR was ordered in n = 21/28 (75.0%) of anti-HDV positive patients, and 76.2% had detectable HDV-RNA. Among viremic patients, 75% and 37.5% had significant fibrosis (≥ F2) or cirrhosis (F4), respectively. The prevalence of anti-HDV among HBsAg-positive patients is considerable in a large hospital located in Central Europe. Double reflex testing, i.e., anti-HDV being triggered by the presence of HBsAg and HDV-PCR bring triggered by the presence of anti-HDV, seems warranted to increase the diagnostic yield., (© 2024. The Author(s).)

Background: Diabetes mellitus, human immunodeficiency virus (HIV), hepatitis B and anaemia are major global public health issues according to the World Health Organization (WHO). Access to diagnostic testing is essential for their prompt detection and treatment. The WHO has recommended a list of essential in-vitro diagnostics for testing at all levels of care. However, a survey preceding this study showed limited availability of point-of-care (POC) tests for these conditions in the Bono Region (BR) of Ghana. This study assessed the geographical access to diabetes, anaemia, hepatitis B, and HIV POC testing in the BR, Ghana for targeted improvement., Methods: We gathered the geolocated data of 137 facilities (CHPS, Clinics, healthcare centres, and hospitals) in the BR that were providing glucose, haemoglobin (Hb), Hepatitis B Surface Antigen (Hep B), and HIV POC testing services in July 2022. We used ArcGIS 10.1 to quantify the geographical access (distance and travel time) to the nearest available testing site for each test and show places with inadequate access, for targeted improvement. The journey time was calculated assuming a speed of 20 kilometres (km)/h. ArcMap 10.1 was employed to run spatial autocorrelation (Moran Index (MI)) to determine the spatial distribution of the facilities providing the tests investigated., Results: Of the 137 facilities, the glucose test was available in 67 (49%), the Hb test in 55 (40%), the Hep B test in 44 (32%), and the HIV test in 73 (53%). The mean (standard deviation (SD)) for obtaining glucose tests in the region was 7.4 ± 3.7 km, Hb was 8.1 ± 4.06 km, Hep B was 8.2 ± 4.1 km, and HIV test was 7.3 ± 3.7 km by a motorised cycle. The mean SD travel time in the region to obtain the glucose test was 94.4 ± 47.2 min compared to 95.7 ± 47.8 min for Hb, 95.9 ± 47.93 min for Hep B, and 92.7 ± 46.3 min for the HIV test. Three districts (Berekum East, Dormaa East, and Jaman North) recorded shorter distances (< 10 km) and a shorter travel time to the glucose, Hb, Hep B, and HIV tests compared to the Banda district, which recorded more than 10 km for all tests investigated. Positive IM values were recorded for all the POC tests, suggesting that the health facilities providing the glucose, Hb, Hep B, and HIV tests in the BR were spatially distributed at random., Conclusions: The findings revealed moderate access to all the tests in districts across the region. However, geographical access to glucose, Hb, Hep B, and HIV POC testing was poor (distance ≥ 10 km and travel time of ≥ 93 min), in the Banda district. This study showed the need to prioritise the Banda district for targeted improvement for all the tests. A further study is recommended to identify potential solutions to addressing the POC testing implementation in the BR, as demonstrated by this study., (© 2024. The Author(s).)

This study aimed to develop an extraction-free method for quantitative and qualitative detection of HBV DNA compared to traditional nucleic acid extraction. Paired serum and dried blood spot (DBS) samples from 67 HBsAg-positive and 67 HBsAg-negative individuals were included. Two samples with known HBV DNA titers (~ 10 9 copies/mL) were examined by extraction-free detection using three surfactants (0.2 to 1% of Sodium dodecyl sulfate:SDS, N-Lauroylsarcosine sodium salt:NL, Sodium dodecyl benzene sulfonate:SDBS), two stabilizing agents (0.1 or 0.01% 2-Mercaptoethanol:2ME and 3.5 or 7% Bovine Serum Albumin:BSA) and two Taq polymerases (Fast Advanced and Prime Direct Probe). HBV DNA in all 67 HBsAg-positive and 67 HBsAg-negative serum and DBS samples was directly quantified by Rt-PCR using 0.4% SDS or 0.4% NL with Fast Advance or Prime Direct Probe Taq. Extraction-free amplification was also performed. Detection limits were varied by different surfactants and Taq. SDS combined with Fast Advanced Taq showed lower detection limits, while SDS with Prime Direct Probe Taq outperformed NL or SDBS-based detection. Adding 2ME to SDS improved detection limit with Prime Direct Probe Taq but not significantly compared to SDS alone. BSA did not significantly enhance detection limits but provided insights into sample stability. The senitivity and specificity of 0.4% SDS and NL in combination with either Fast advanced or Prime Direct Probe Taq polymerase in serum samples were > 90% and 100% resepctively, while it was > 80% and 100% respectively in DBS samples. Extraction-free HBV DNA amplification provided 100% identity with original genomes. Our study suggests that SDS, NL or SDBS-based extraction-free HBV DNA detection strategies using Prime Direct Probe Taq have potential to simplify and accelerate HBV DNA detection with high sensitivity and specificity in both serum and DBS samples, with implications for resource-limited settings and clinical applications. Utilizing surfactants with 2ME is optional, and further research and validation are necessary to broaden its application in real-world diagnostics., (© 2024. The Author(s).)

Background: Hepatitis B is an infectious disease of worldwide importance and of great interest to transfusion medicine. The Amazon region has areas of high endemicity, outlining a worrying scenario for transfusion and epidemiological safety., Objective: To analyze the profiles of serological and molecular markers for HBV of blood donors from HEMOAM., Methods: Blood donors with different patterns of reactivity in serological and molecular screening for HBV were tested for viral load by the qPCR method at the reference center for liver diseases in the state of Amazonas., Results: A total of 230,591 donors were tested, with 3104 (1.34%) found reactive for HBV and 2790 (89.9%) found reactive for isolated anti-HBc. Viral load was not detected in 100% of donors reactive only to HBsAg, while 100% of donors with positive anti-HBc and positive HBsAg or HBV NAT demonstrated a detectable viral load. We also detected one case of occult hepatitis B (0.03%) only with reactive HBV NAT and five donors (0.2%) with positive anti-HBc and HBV NAT., Conclusions: With this result, the great importance of the anti-HBc test for the unsuitability of blood donors was verified, as well as the fundamental introduction of the HBV NAT test in screening for hepatitis B in Brazilian blood banks, as this was the only way to detect the viral infection burden in asymptomatic donors who previously would not be treated, which contributed to the maintenance of the endemicity of hepatitis B in the Brazilian Amazon.

Hepatitis B virus (HBV) causes hepatitis B (HB) and distinct HBV genotypes can lead to different prognoses. However, HBV genotyping is rarely done in clinics, because the traditional method by PCR-based DNA sequencing is impractical for clinical diagnosis with tedious process and low success rate. Herein, we have established an ELISA-based genotyping method to quickly determine the HBV genotypes of HB patients in China. First, two commercial antibodies, 16D12 and 6H3 specific for HBV genotypes B and C respectively, are chosen as capture antibodies, since these two genotypes dominate in China. Then two home-made genotype-specific antibodies, B19 and C04, are used as the detection antibodies for genotypes B and C in sandwiched ELISA. The ELISA kit shows high sensitivity (> 95%) and specificity (> 95%) in detecting genotypes B and C of Chinese HB patients. Moreover, the ELISA kit has demonstrated higher success rate (98.7%) than PCR-based DNA sequencing (93.5%) and a commercial PCR-based genotyping kit (92.2%) for sera with HBV DNA ≥ 1000 IU/mL and HBsAg ≥ 250 IU/mL. Such an advantage is more obvious for the sera with HBV DNA < 1000 IU/mL. The kappa analysis between the ELISA and PCR-based DNA sequencing results exhibits a kappa of 0.836, indicating a good correlation., (© 2024. The Author(s).)

Background: The current hepatitis B (HBV) and hepatitis C virus (HCV) screening practices may fail to detect many infected patients who could benefit from new therapeutic agents to limit progression to cirrhosis and hepatocellular carcinoma., Objectives: This study assessed the test positivity rate and cascade of care of viral hepatitis patients in primary care in a low endemic region as well as the testing policy of abnormal alanine aminotransferase (ALT) level., Methods: This is a retrospective clinical audit among primary health care practices in Flanders, Belgium, assessing patients with an active medical file between 2019 and 2021., Results: A total of 84/89 (94.4%) primary health care practices participated representing 621,573 patients of which 1069 patients (0.17%) were registered as having viral hepatitis, not further specified. Detailed information was available from 38 practices representing 243,723/621,573 (39.2%) patients of which 169 (0.07%) were HBsAg positive and 99 (0.04%) anti-HCV positive. A total of 96/134(71.6%) chronic HBV-infected and 31/77(40.3%) chronic HCV-infected patients were referred to a hepatologist. A total of 30,573/621,573(4.9%) patients had an abnormal ALT level, and by at random selection, more detailed information was obtained on 211 patients. Information on high-risk groups was missing in up to 60%. In patients with abnormal ALT level, HBsAg and anti-HCV testing were conducted in 37/211(17.5%) and 25/211(11.8%), respectively., Conclusion: In a low endemic region, the testing rate and cascade of care of HBV and HCV-infected patients can be improved in primary care, especially in high-risk groups and patients with abnormal ALT levels., (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

The increasing use of non-tenofovir containing antiretroviral regimens calls for renewed attention to the prevention and management of hepatitis B virus (HBV) in people with HIV (PWH). We retrospectively assessed adherence to HBV guidelines, including complete HBV screening in PWH. In people with HIV/HBV co-infection, this included HBV therapy, screening for hepatitis delta virus (HDV) and on-therapy virologic response monitoring. HIV/HBV co-infection in PWH was defined as the presence of hepatitis B surface antigen (HBsAg) at the last measurement before study entry or detectable HBV-DNA for ≥6 months. After assessment, missing laboratory tests were performed to optimize HBV monitoring and screening for co-infections. Of all PWH under follow-up, 1484/1633 (90.9%) were adequately screened for HBV. After performing missing screening tests, 466 of 1618 PWH with complete screening results (28.8%) were non-immune for HBV infection. Fifty-one (3.2%) with HIV/HBV co-infection were identified. HBV treatment was adequate in 51/51 (100%). Screening for hepatitis A, C and delta virus antibodies and fibrosis was performed in 51/51 (100%), 49/51 (96.1%), 17/51 (35.3%) and 38/51 (74.5%). Annual HBV-DNA or HBsAg monitoring was done in 18/51 (35.3%) and hepatocellular carcinoma (HCC) surveillance in 2/9 (22.2%) of those indicated. Additional testing in those with missing data identified 4/34 (11.8%) persons with HDV antibodies and 3/30 (10%) with HBsAg seroclearance. Our study demonstrates the feasibility and added value of evaluating HBV care components and performing missing laboratory tests, identifying a large number of HBV vaccination candidates and HDV antibody screening, HBsAg monitoring and HCC surveillance as key areas for improvement., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Accurate laboratory confirmation for Hepatitis B diagnosis and monitoring are crucial. Recently an ultrasensitive immunoassay test, the HBsAg Next (HBsAgNx), has been reported approximately eight times more sensitive than current HBsAg assays. The aim of our study was to assess the analytical performances of this new test., Methodology: 253 clinical samples from Saint Louis University Hospital were analyzed, splitted into four panels: (1) routine prospectively screening serums (n = 196), (2) retrospective serum samples before HBV reactivation (HBV-R) (n = 18), (3) occult HBV infection (OBI) (n = 10) and (4) a selection of wild type HBV genotypes (n = 29) RESULTS: Panel 1, showed robust agreement with the HBsAg Qualitative II (HBsAgQII) assay (Cohen's kappa = 0.83). Despite this agreement, 7 false positive with the HBsAgQII assay were found negative with HBsAgNx. One OBI was detected only with HBsAgNx. Panel 2 showed potential time savings in diagnosing HBV-R using HBsAgNx among 4/18 HBsAg positives samples. Panel 3 highlighted the ability of HBsAgNx to detect HBsAg in OBI patients defined by negative for HBsAg with HBsAgQII assay and positive for HBV DNA. Furthermore, the HBsAgNx assay detected all different genotypes., Conclusion: The study highlights the effectiveness of the HBsAgNx assay, showing its performance. It excels in detecting weakly positive samples and addressing challenging cases. HBsAgNx assay demonstrates promising analytical performances, with improved sensitivity and specificity compared to standard HBsAgQII assay, able to detect all genotypes. Its potential impact on early detecting and monitoring reactivations, and occult infections could be very useful in clinical practice., Competing Interests: Declaration of competing interest All authors declare no conflict of interest for this work., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: This study assessed the epidemiology of hepatitis delta virus (HDV) within the University of Utah UHealth health care system (2000-2021)., Methods: Analysis of HDV/HBV testing, diagnostic codes, liver enzymes, and comorbidities was performed., Results: Among the 1962 HBV patients, only 22.2% underwent HDV testing, revealing an 8.3% positivity rate for HDV coinfections. This study observed a consistent increase in HBV and HDV cases, with higher HDV detection rates linked to increased testing. Limited HDV testing and potential screening biases were evident., Discussion: Improved HDV testing and surveillance are crucial for early detection and implementation of targeted therapies., Competing Interests: Potential conflicts of interest. M. L. W. and K. M. L. have current funding from Gilead Sciences, Inc. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Background: Routine screening for viral infections at blood donation is important to avoid transfusion-transmitted infections. It also offers an opportunity to detect an asymptomatic infection., Objective: To study changes in serology positivity for viral infections (B and C hepatitis, HTLV-1/2, and HIV) at blood donation in a blood bank from Southern Brazil, comparing two periods of 5 years: the period from 2013 to 2017 with the period from 2018 to 2022. In addition, data on the donor fidelity rate during the studied period were sought., Methods: Retrospective study using data from 2013 to 2022 from a single blood center electronic database from Curitiba, Southern Brazil., Results: A significant drop in positive serology for all studied viruses was observed: highest in HIV (OR=0.39; 95% CI=0.27-0.57) and lowest in total anti HBc (0.56; 95 CI=0.50-0.63). Anti HBc serology became more commonly seen in women in the period of 2018-2022 when compared to men. No changes in the distribution of positive serology according to donors' ages were observed. Loyalty rates had a median of 70%, with the lowest being 60% in 2013, while the highest was 73% in 2018 and 2022., Conclusion: A significant reduction in discarded blood bags due to viral serology was observed when the period of 2013-2017 was compared to 2018-2022 on this blood bank; the highest reduction was observed in HIV serology and the lowest in HBc serology, which became more common in women in the second period. High rates of donor fidelity were observed during the period studied.

Background: Most Chinese blood centers have implemented mini pool (MP) HBV nucleic acid testing (NAT) together with HBsAg ELISA in routine blood donor screening for HBV infection since 2015, and a few centers upgraded MP to individual donation (ID) NAT screening recently, raising urgent need for cost-benefit analysis of different screening strategies. In an effort to prevent transfusion-transmitted infections (TTIs) for HBV, cost-benefit analyses of three different screening strategies: HBsAg alone, HBsAg plus MP NAT and HBsAg plus ID NAT were performed in blood donors from southern China where HBV infection was endemic., Methods: MP-6 HBV NAT and ID NAT were adopted in parallel to screen blood donors for further comparative analysis. On the basis of screening data and the documented parameters, the number of window period (WP) infection, HBV acute infection, chronic hepatitis B infection (CHB) and occult hepatitis B infection (OBI) was evaluated, and the potential prevented HBV TTIs and benefits of these three strategies were predicted based on cost-benefit analysis by an estimation model., Results: Of 132,323 donations, the yield rate for HBsAg-/DNA + screened by ID NAT (0.12%) was significantly higher than that by MP NAT (0.058%, P < 0.05). Furthermore, the predicted transfusion-transmitted HBV cases prevented was 1.25 times more by ID NAT compared to MP-6 NAT. The cost-benefit ratio of the universal HBsAg screening, HBsAg plus ID NAT and HBsAg plus MP NAT were 1:58, 1:27 and 1:22, respectively., Conclusions: Universal HBsAg ELISA screening in combination with HBV ID NAT or MP-6 NAT strategies was highly cost effective in China. To further improve blood safety, HBsAg plus HBV DNA ID NAT screening should be considered in HBV endemic regions/countries., (© 2024. The Author(s).)

Background: The high sensitivity of HBsAg quantitative tests has led to some challenges in the qualitative interpretation of weakly positive specimens. This study aimed to explore the clinical utility of neutralization confirma-tory testing for specimens with low positive hepatitis B surface antigen (HBsAg)., Methods: A retrospective analysis was conducted on outpatient and inpatient cases, from January 2021 to January 2022, at the Zhongshan City People's Hospital, Zhongshan. Confirmatory testing as well as enzyme-linked immunosorbent assay (ELISA) was applied to reanalyze 382 samples with low positive HBsAg detected by chemilumi-nescence microparticle immunoassay (CMIA). A retrospective analysis of hepatitis B serum markers, including e-antigen, e-antibody, and core antibody patterns, was also performed., Results: When the HBsAg value ranged from 0.05 - 0.09 IU/mL, the positivity rate of the confirmatory testing was 34.5%. The HBsAg true positivity levels were all between 0.07 and 0.09. In the range of 0.10 - 0.49, the positivity rate of confirmatory testing was 96.1%. The three methods exhibited a high consistency, when testing samples with relatively high HBsAg values. A receiver operating characteristic (ROC) analysis showed that the optimal sensitivity and specificity were achieved at 0.14 IU/mL. For the HBV e-antigen-positive and negative groups, the positivity rate of confirmatory testing was 100% and 93.8%, with no statistical difference between them., Conclusions: For specimens with weakly positive, low-value HBsAg, particularly when the hepatitis B surface an-tigen level is less than 0.14 IU/mL, neutralization confirmatory testing can serve as a means for further confirmation.

Background: Sub-Saharan African countries have a high burden of viral hepatitis and poor access to screening and care. The aim of this study was to evaluate the feasibility and acceptability of using the plasma separation card (PSC) for viral hepatitis B and C screening among people living with HIV (PLHIV) in Cameroon and Uganda., Methods: This is a cross-sectional study carried out between 05/2021 and 03/2023 including 192 PLHIV in Cameroon (n = 104) and Uganda (n = 88). Basic sociodemographic variables and whole blood samples were collected. Adequate filling with blood of PSCs was used to determine feasibility together with participant responses to questions on acceptability. A logistic regression model was carried out to assess the relationship between PSC acceptability and factors of interest., Results: 70% of participants reported PSC as an acceptable viral hepatitis screening tool, and it was significantly more accepted in Uganda than Cameroon (100% vs. 43.2%, p < 0.001). Similarly, 75% of PSCs had at least one spot sample filled and were viable for analysis, 99% were correctly filled in Uganda and 53.4% in Cameroon. Reported ease of method performance (aOR: 24.77 95% CI 2.97-206.42, p = 0.003) and reduced collection time (aOR: 3.73 95% CI 1.26-11.04, p = 0.017) were associated with greater odds of PSC acceptance. HBsAg + and anti-HCV + prevalence were 11.1% and 1.0%, respectively., Conclusions: In spite of country differences, overall, the PSC was reported as a feasible and acceptable viral hepatitis testing method. Acceptability and feasibility of the method must be explored in heterogeneous target communities and qualitative research to better understand country-specific barriers and facilitators should be carried out., (© 2024. The Author(s).)

Developing acute hepatitis B in immunocompetent non-responders to hepatitis B vaccination has been rarely reported. We report such a case in a 79 year old heterosexual male. There is evidence that tenofovir disoproxil/emtricitabine as primary prophylaxis can prevent acquisition of hepatitis B. In the current era of HIV pre-exposure prophylaxis (PrEP) with tenofovir disoproxil/emtricitabine, there is dual benefit of preventing HIV and hepatitis B. We discuss the importance of considering tenofovir disoproxil/emtricitabine pre-exposure prophylaxis in those hepatitis B vaccination non-responders at high risk of acquiring hepatitis B., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The number of new infections of hepatitis B is rising and a large number of cases are undiagnosed. These factors are contributing to hepatitis B-related liver complications, including liver cancer, and deaths that could be prevented. The Advisory Committee on Immunization Practices and the Centers for Disease Control and Prevention recently updated vaccination and screening/testing recommendations for hepatitis B. The updated recommendations remove the need for risk assessment before screening or vaccination. Pharmacists will play a key role in a concerted national effort to implement these updated recommendations. A multistakeholder advisory council convened by the Hepatitis B Foundation identified key barriers to screening and vaccination. The council also formulated strategies to optimize implementation of the updated recommendations. These strategies include educating pharmacists about the new recommendations and how they will help to reduce the burden of hepatitis B and liver cancer. Pharmacists could explore establishing pharmacy-provider collaborative practice agreements and potentially leverage capacity built with COVID-19 vaccine implementation. Hospital systems and other clinic settings could update their electronic health records to include prompts for hepatitis B vaccination and screening. Pharmacy systems can implement different reminder options to help patients complete the hepatitis B vaccine series. To address a lack of vaccine confidence, pharmacists can emphasize the cancer prevention benefit of hepatitis B screening and vaccination and engage with patients on an individual level to understand their concerns, assess vaccine status, and discuss vaccine recommendations. Effective implementation of the new recommendations will help achieve national and global goals of eliminating hepatitis B as a public health threat by 2030., Competing Interests: Disclosure The author declares no relevant conflicts of interest or financial relationships., (Copyright © 2024 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Epstein-Barr virus-associated smooth muscle tumor (EBV-SMT) is rare in adults. The presence of intratumoral T lymphocytes and primitive rounded cells characterized this neoplasm. We report a 24-year-old Chinese man who developed EBV-SMT in the right adrenal gland with hepatitis B infection and autoimmune hemolytic anemia without a history of HIV infection, primary immune deficiency, organ transplantation, or malignant tumor. This patient had an unknown immunodeficient state. EBV-SMTs are commonly located in the liver, lung, and gastrointestinal tract but rarely in the adrenal gland. We reviewed 10 reported literature on EBV-SMT in the adrenal gland. It is imperative to distinguish EBV-SMT from conventional somatic smooth muscle tumors. The discovery of EBV-SMT forces the clinician to conduct a thorough evaluation of immune function and immune status surveillance, and these patients are vulnerable to subsequent malignant tumors., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: In France, migrants constitute a significant proportion of people diagnosed with HIV, hepatitis C (HCV) and B (HBV). This study estimated the prevalence of these three viruses among detainees at a French administrative detention centre (CRA), through systematic Rapid Diagnostic Test (RDT) screening., Methods: This prospective, single-centre, cross-sectional, pilot study included detainees at the Nîmes CRA from February to December 2022. The primary endpoint was HIV, HCV and HBV prevalence determined by RDT. Secondary outcomes were: co-infections; study acceptability, reasons for non-inclusion, causes of non-contributory samples; and concordance between serological tests and RDT., Results: Among the 350 people agreeing to participate of 726 eligible, five refused the RDT, leaving 345 analysable participants for a participation rate of 47.5% (345/726). Participants were predominantly male (90%) with an average age of 31 years. The most common country of origin was Algeria (34%). Twenty (6%) had taken drugs intravenously and 240 (70%) had had unprotected sex within a median of 4.92 [1.08; 15] months. Virus prevalence was: 0% HIV; 4.64 [2.42; 6.86] % HCV; and 2.32 [1.01; 4.52] % HBV. Eleven (73%) of the RDT HCV positive cases were confirmed serologically. RDT detected one false-positive HCV case, as an anti-HCV Ac serological test was negative. Of the eight patients with positive HBV RDT, one declined the serology testing, thus 100% (7/7) of the tested RDT positive cases were confirmed by serology., Conclusion: The study highlighted the need to screen detainees for HIV, HCV and HBV infection and suitability of RDTs., (© 2024. The Author(s).)

This study evaluated the diagnostic and analytical performances of the Access anti-HBc Total assay on the DxI 9000 Access Immunoassay System (Beckman Coulter Inc.). The multicenter study involved both prospective and retrospective sample collection from non-selected blood donors, hospitalized patients, or presumed anti-HBc Total positive individuals. Fresh/previously-frozen samples were tested with the Access and comparator assays to determine concordance; discrepant samples were tested with a second CE-marked assay. Among the 5983 non-selected fresh blood donor samples deemed anti-HBc Total negative, clinical specificity of the Access assay was 99.58% (95%CI: 99.38-99.72%). Clinical specificity was 99.27% (97.37-99.80%) among 273 anti-HBc Total negative hospitalized patient samples. Clinical sensitivity on 450 anti-HBc Total positive samples was 99.78% (98.75-99.96%). Evaluation in seroconversion panels revealed an average 1.4-day earlier detection versus a comparator assay. The Access assay demonstrated excellent clinical and analytical performances comparable to existing CE-marked anti-HBc Total assays. NCT04904835., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Rima Bayoud, Juliane Hey, Gaiane Demirdjian, Magali Karagueuzian, and Derrick Afful are Beckman Coulter employees., (Copyright © 2024. Published by Elsevier Inc.)

Objectives: Hepatitis B (HBV) and hepatitis C (HCV) viruses are significant causes of primary liver cancer, responsible for over a million deaths annually. We aimed to develop a screening strategy for viral hepatitis elimination in Spain, aligned with WHO's 2030 objectives., Design: The CRIVALVIR-FOCUS program, conducted at the Consortium General University Hospital of Valencia, aimed to identify individuals with active blood-borne viral infections through opportunistic population screening. The hospital's Health Department serves more than 280,000 adults., Results: Of the 31,995 adults screened (52% women; 15% immigrants), HBV prevalence was 0.44%, with higher rates in men (0.57%) than women (0.32%), and notably higher in migrants (1.27%) compared to Spanish nationals (0.30%). The 45-64 age group had the highest HBV prevalence (0.65%). HCV prevalence was 0.35%, again higher in men than women (0.51% vs 0.20%) and in migrants compared to Spanish nationals (0.58% vs 0.31%), with the 45-64 age group showing the highest HCV prevalence (0.76%). From the positive tests, 78.0% (110/141) of HBV cases and 71.4% (80/112) of HCV cases were patients previously unaware of their infections., Conclusion: Opportunistic screening effectively identifies early cases, potentially enhancing prevention of new infections. Our study highlights the need for targeted interventions for individuals aged 45-64 and migrants. Designing specific screening programs, in collaboration with social workers and cultural mediators, is critical to improve access to care. Training and involving primary care professionals are vital actions for the program's success., Competing Interests: Declaration of competing interest Alba Carrodeguas and José Luis González-Sánchez own shares in and are employees of Gilead Sciences. The remaining authors declare no conflicts of interest regarding this research, authorship, and publication of this article., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Viral hepatitis during pregnancy is common globally. In this review, we focus on the antenatal screen for hepatitis A, B, C and E, the prevention of mother-to-child transmission (MTCT) of hepatitis B and C, and the management of hepatitis A, B, C and E during pregnancy. Neonatal timely administration of hepatitis B immunoglobulin and hepatitis B vaccine is the cornerstone for preventing MTCT of hepatitis B virus (HBV), and perinatal antiviral prophylaxis with tenofovir disoproxil fumarate in mothers with positive HBeAg or HBV DNA >2 × 10 5 IU/ml also plays important roles in further reducing MTCT. Avoidance of risk practices in managing labor and delivery process of women with HCV infection may be useful to reduce MTCT of HCV. Early recognition of severe hepatic injury or liver failure associated with hepatitis viruses by regular liver function tests is critical to prevent maternal mortality associated with hepatitis., Competing Interests: Declaration of competing interest The author has no conflicts of interest to report., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Background: The use of nucleos(t)ide analogs (NAs) with a high genetic barrier to resistance, namely entecavir and tenofovir, has improved the efficacy of antiviral prophylaxis against hepatitis B virus (HBV) recurrence after liver transplantation (LT). However, the optimal duration and dosage of hepatitis B immunoglobulin (HBIG) administration, particularly in patients transplanted for HBV and hepatitis D virus (HDV) coinfection, remains controversial., Methods: We evaluated 28 patients transplanted for HBV/HDV cirrhosis. After LT, each patient received a fixed scheme of low-dose HBIG plus NA for 6 mo post-LT and then continued with long-term NA prophylaxis (entecavir: 8, tenofovir: 20 patients)., Results: During 72 mo of follow-up, reappearance of hepatitis B surface antigen at low titers was observed in 1 (3.6%) patient at 33 mo after HBIG discontinuation, which became negative after a single dose of HBIG 1000 IU/L, whereas both serum HBV DNA and HDV RNA remained persistently undetectable and without any clinical or biochemical evidence of HBV/HDV recurrence., Conclusions: We showed for the first time the efficacy of a short, fixed scheme of low-dose HBIG plus NA followed by long-term NA monoprophylaxis against HBV/HDV recurrence after LT, although careful follow-up is needed after HBIG discontinuation, whereas further larger studies are needed to confirm these findings., Competing Interests: The authors declare no funding or conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

This paper investigates linkage to care following community-based screening for hepatitis B virus (HBV) in rural Senegal. HBV-positive participants who completed a biological and clinical examination to assess liver disease and treatment eligibility were referred to a regional hospital (if eligible for treatment), invited to join the Sen-B research cohort study (adults with detectable viral load) or referred to their local health centre (all others). Logistic regressions were conducted to investigate factors associated with (i) uptake of the scheduled post-screening examination, and (ii) HBV management initiation. Obstacles to HBV management were identified using thematic analysis of in-depth patient interviews. Of the 206 HBV-positive participants, 163 (79.1%) underwent the examination; 47 of the 163 (28.8%) initiated HBV management. Women, people not migrating for >6 months/year, individuals living in households with more agricultural and monetary resources, with other HBV-positive participants, and beneficiaries of the national cash transfer program, were all more likely to undergo the examination. The likelihood of joining the Sen-B cohort increased with household monetary resources, but decreased with agricultural resources. Initiation of HBV management in local health centre was higher among participants with a non-agricultural economic activity. Individuals reported wariness and confusion about HBV management content and rationale at various stages of the care continuum, in particular with respect to venous blood sampling and management without treatment. In conclusion, HBV community-based test-and-treat strategies are feasible, but early loss to follow-up must be addressed through simplified, affordable management and community support and sensitization., (© 2024 The Author(s). Journal of Viral Hepatitis published by John Wiley & Sons Ltd.)

Due to shared routes of transmission, including sexual contact and vertical transmission, HIV-HBV co-infection is common, particularly in sub-Saharan Africa. Measurement of viral load (VL), for both HIV and HBV, plays a critical role for determining their infectious phase and monitoring response to antiviral therapy. Implementation of viral load testing in clinical settings is a significant challenge in resource-limited countries, notably because of cost and availability issues. We designed HIV and HBV primers for conserved regions of the HIV and HBV genomes that were specifically adapted to viral strains circulating in West Africa that are HIV-1 subtype CRF02AG and HBV genotype E. We first validated two monoplex qPCR assays for individual quantification and, then developed a multiplex qPCR for simultaneous quantification of both viruses. HIV RNA and HBV DNA amplification was performed in a single tube using a one-step reverse transcription-PCR reaction with primers and probes targeting both viruses. Performance characteristics such as the quantification range, sensitivity, and specificity of this multiplex qPCR assay were compared to reference qPCR tests for both HIV and HBV viral load quantification. The multiplex assay was validated using clinical samples from co- or mono-infected patients and gave comparable viral load quantification to the HIV and HBV reference test respectively. The multiplex qPCR demonstrated an overall sensitivity of 71.25 % [68.16-74.3] for HBV and 82 % [78.09-85.90] for HIV and an overall specificity of 100 % [94.95-100] for both viruses. Although the overall sensitivities of the HIV and HBV assays were lower than the commercial comparator assays, the sensitivity in the clinical decision range of >1000 copies/mL for HIV was 80 % [71.26-88.73] and >1000 IU/mL for HBV was 100 % [95.51-100] which indicates the test results can be used to guide treatment decisions. This in-house developed multiplex qPCR assay represents a useful diagnostic tool as it can be performed on affordable "open" real-time PCR platforms currently used for HIV or SARS-Cov-2 infection surveillance in Mali., Competing Interests: Declaration of Competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Hepatitis B virus (HBV) infection remains a major public health problem and, in associated co-infection with hepatitis delta virus (HDV), causes the most severe viral hepatitis and accelerated liver disease progression. As a defective satellite RNA virus, HDV can only propagate in the presence of HBV infection, which makes HBV DNA and HDV RNA the standard biomarkers for monitoring the virological response upon antiviral therapy, in co-infected patients. Although assays have been described to quantify these viral nucleic acids in circulation independently, a method for monitoring both viruses simultaneously is not available, thus hampering characterization of their complex dynamic interactions. Here, we describe the development of a dual fluorescence channel detection system for pan-genotypic, simultaneous quantification of HBV DNA and HDV RNA through a one-step quantitative PCR. The sensitivity for both HBV and HDV is about 10 copies per microliter without significant interference between these two detection targets. This assay provides reliable detection for HBV and HDV basic research in vitro and in human liver chimeric mice. Preclinical validation of this system on serum samples from patients on or off antiviral therapy also illustrates a promising application that is rapid and cost-effective in monitoring HBV and HDV viral loads simultaneously.

Objective: Premarital screening is one of the most important strategies for preventing infectious diseases such as hepatitis B virus, hepatitis C virus, and human immunodeficiency virus in populations. This study aims to explore the prevalence of these viruses and their association with potential demographic factors among individuals undergoing premarital screening in Saudi Arabia., Methods: A cross-sectional study design using the National Healthy Marriage Program electronic registry in the Saudi Ministry of Health. Patients were selected from the premarital screening tests for the three blood-borne viruses. Data were obtained from January to August 2021 among 114,740 individuals., Results: Hepatitis B virus infection showed the highest prevalence followed by hepatitis C and human immunodeficiency viruses. Among those who were infected, men had higher infectious disease prevalence than women. The central and western regions had the highest percentages of infection., Conclusion: The studied infections pose a continuous public health issue among premarital screening individuals in Saudi Arabia. This study identified important demographic risk factors for these diseases and highlighted the need for future strategies and long-term plans at the national level., Competing Interests: The authors declare that they do not have any conflicts of interest., (Copyright © 2024 Alfadhli, Sulimani, Fadl, Bin Jumah, Alanazi and Alangari.)

Background: Hepatitis B virus (HBV) infection is a major concern regarding blood safety in countries with a high HBV prevalence, such as China. We aimed to understand the prevalence of HBV infection among blood donors in Chongqing and provide an important basis for developing appropriate blood screening strategies., Methods: Dual enzyme-linked immunosorbent assays (ELISAs) for hepatitis B surface antigen (HBsAg) were conducted in parallel with nucleic acid testing (NAT) of donors. All HBsAg-reactive and/or HBV DNA-positive blood samples were tested for HBsAg and hepatitis B DNA levels., Results: A total of 117,927 blood donor samples were collected from the Chongqing Blood Center between April 2020 and November 2020. In total, 473 HBV-ineligible samples were retained for HBsAg and DNA confirmation. A total of 272 samples were confirmed to be HBsAg+, including 2 HBV DNA - and 270 HBV DNA + samples. A total of 201 donations were HBsAg-, including 72 HBV DNA - samples. The rate of HBV infection was 65.33% (309/473) in men, which was significantly higher than that in women (p < 0.001). The HBV failure rate was higher among the first-time donors (p < 0.05). Of the 182 NAT R/HBsAg N/N samples (Nucleic acid test reactivity/2 anti-HBsAg tests negative), 37.91% (69/182) were false positives. The proportion of hepatitis B infections in the 18 NAT R/HBsAg N/R (Nucleic acid test reactivity/1 anti-HBsAg tests negative) samples was 94.44% (17/18), of which 50% (9/18) were occult HBV infection. A total of 95.83% (69/72) of the false positives were from the NAT R/HBsAg N/N group, and 58.33% (42/72) were first-time donors., Conclusion: Our data showed a strikingly high HBV infection rate among blood donors in Chongqing. Double ELISA and single NAT can effectively prevent HBV leakage and improve blood safety. First-time donors have a high rate of HBV transplant failure; therefore, donors should be retained and recruited from low-risk groups., (© 2024. The Author(s).)

Hepatitis B virus (HBV) infection poses a considerable public health challenge in limited-resource settings especially in the sub-Saharan African region. Even though HBV infection is incurable, timely treatment is effective in preventing disease progression to liver cirrhosis or hepatocellular carcinoma. However, not all infected patients require treatment. The aim of the study was to determine the clinical, immunological, and virological profiles of treatment naïve patients with HBV infection, seen at the outpatient clinic of the Cape Coast Teaching Hospital. Additionally, the study sought to determine the antiviral treatment eligibility rate based on the 2015 guidelines of the World Health Organization (WHO) compared with the new 2024 guidelines. A hospital-based cross-sectional study involving total sampling of 220 treatment naïve HBV surface antigen positive clients was carried out. A structured questionnaire was used to collect data that were analyzed with STATA version 16. The median age at diagnosis was 34 years (IQR 26.0-41.5) with a male to female ratio of 1:1.5. A total of 138 participants (62.7%) were diagnosed with HBV infection following voluntary testing. There was a median delay of 8.5 months (IQR 3.0-22.5) between initial diagnosis and patients' presentation for medical care. In all, 24 patients (10.9%) had abnormal clinical examination findings, 172 patients (78.2%) had HBV DNA levels ≤ 2000 IU/ml whereas 8 (3.6%) were seropositive for the HBV envelope antigen. A few patients had concomitant human immunodeficiency virus (2.7%) and hepatitis C virus (1.4%) infections. Treatment eligibility rate based on the WHO 2015 guidelines was 6.4% (n = 14), however, with the updated 2024 guidelines, treatment eligibility was 42.3% (n = 93). Increasing the screening rate among the general population, early linkage to clinical care of screen positives and vaccination of screen negatives will help reduce HBV-related clinical conditions in resource-limited settings., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Daniels et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Gut microbiota (GM) affects the progression and response to treatment in liver diseases. The GM composition is diverse and associated with different etiologies of liver diseases. Notably, alterations in GM alterations are observed in patients with portal hypertension (PH) secondary to cirrhosis, with hepatitis B virus (HBV) infection being a major cause of cirrhosis in China. Thus, understanding the role of GM alterations in patients with HBV infection-related PH is essential., Aim: To evaluate GM alterations in patients with HBV-related PH after transjugular intrahepatic portosystemic shunt (TIPS) placement., Methods: This was a prospective, observational clinical study. There were 30 patients (with a 100% technical success rate) recruited in the present study. Patients with esophagogastric variceal bleeding due to HBV infection-associated PH who underwent TIPS were enrolled. Stool samples were obtained before and one month after TIPS treatment, and GM was analyzed using 16S ribosomal RNA amplicon sequencing., Results: One month after TIPS placement, 8 patients developed hepatic encephalopathy (HE) and were assigned to the HE group; the other 22 patients were assigned to the non-HE group. There was no substantial disparity in the abundance of GM at the phylum level between the two groups, regardless of TIPS treatment (all, P > 0.05). However, following TIPS placement, the following results were observed: (1) The abundance of Haemophilus and Eggerthella increased, whereas that of Anaerostipes , Dialister , Butyricicoccus , and Oscillospira declined in the HE group; (2) The richness of Eggerthella , Streptococcus , and Bilophila increased, whereas that of Roseburia and Ruminococcus decreased in the non-HE group; and (3) Members from the pathogenic genus Morganella appeared in the HE group but not in the non-HE group., Conclusion: Intestinal microbiota-related synergism may predict the risk of HE following TIPS placement in patients with HBV-related PH. Prophylactic microbiome therapies may be useful for preventing and treating HE after TIPS placement., Competing Interests: Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article., (©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.)

The prevalence of hepatitis B represents a significant public health concern with a heavy disease burden. In China, there is still a big gap between the current diagnosis and treatment rates of hepatitis B and the goal of eliminating viral hepatitis as a public health threat by 2030 set by the World Health Organization (WHO). In order to achieve the WHO goal and the goal of 2030 Healthy China Outline, the Chinese Preventive Medicine Association organized domestic experts in the fields of clinical medicine, public health and clinical laboratory medicine to develop the Expert Recommendations on Screening, Testing and Management for Hepatitis B Virus Infection in Adults after several rounds of discussion based on comprehensive review of relevant domestic and international guidelines and literatures, the purpose is to facilitate universal screening of hepatitis B virus(HBV)infection in adults and provide practical guidance on disease assessment, treatment and long-term follow-up management of people infected with HBV and vaccination for people susceptible to HBV infection,thus promoting the elimination of the threat of hepatitis B.

Objective: To investigate the prior testing for HIV, syphilis, hepatitis B (HBV), and hepatitis C (HCV) among transgender women and travestis (TGW) in five Brazilian cities and identify factors associated with each of these previous tests., Methods: This is a cross-sectional study with the recruitment of TGW through respondent-driven sampling (TransOdara Study). The investigated outcome variable was prior testing for HIV, syphilis, HBV, and HCV in the last 12 months. The association between sociodemographic and behavioral factors with the outcome was analyzed using a binomial logistic regression with mixed effects. Adjusted odds ratios (aOR) and 95% confidence intervals (CI95%) were estimated., Results: The proportions of individuals with prior testing in the past year were as follows: 56.3% for HIV, 58.0% for syphilis, 42.1% for HBV, and 44.7% for HCV. Negative associations with prior testing were observed for individuals aged 35 years or older, whereas positive associations were found for those with high school education, those who experienced verbal or psychological violence in the last 12 months, and those who had commercial or casual partners in the last 6 months., Conclusion: There was low frequency of testing in the 12 months preceding the study for HIV, syphilis, HBV, and HCV compared to the guidelines established by the Ministry of Health. Expanding access to and engagement with healthcare and prevention services for TGW is an essential strategy in reducing the transmission chain of HIV and other sexually transmitted infections (STIs).

Background: Globally, around 7 to 20 million people are believed to be suffering from coinfection with both hepatitis B virus (HBV) and hepatitis C virus (HCV). The loop-mediated isothermal amplification (LAMP) approach, introduced by Notomi and colleagues, has undergone substantial advancements as an effective molecular tool that enables the simultaneous analysis of multiple samples in a single tube., Methods: The present study examined the simultaneous detection of HBV and HCV in a single tube using melt curve analysis multiplex LAMP (mLAMP), which is based on the identification of unique melting peak temperatures. Selected regions for primer design including the S gene of HBV and the UTR gene of HCV. Primer optimization is initially performed through individual HBV and HCV LAMP analysis. Following the optimization process, the mLAMP assay was evaluated by optimizing the multiplex reaction mixture, determining the reaction time, and analyzing the limit of detection (LOD). The results are also analyzed using lateral flow dipsticks (LFD), which enable the visual detection of HBV and HCV by adding 20 pmol FITC-labeled LF primers into the reaction mixture prior the mLAMP., Results: The LOD for the mLAMP assay was determined as 10 copies/µl, and no cross-reactivity with other microorganisms was detected. The detection results obtained from patient plasma were also visually demonstrated using LFD, and displayed significant concordance with those obtained from Real-Time Polymerase Chain Assay. The mLAMP assay revealed a diagnostic sensitivity of 95% for detecting the HBV, and LOD is 90% for HCV. The overall diagnostic sensitivity of the mLAMP assay for both viruses was 85%. The assay confirmed a specificity of 100%., Conclusion: The mLAMP assay displays significant promise for analyzing coinfected samples by simultaneously detecting the dual targets HBV and HCV within a set temperature of 62 °C, all within a time frame of 1 h. Additionally, when paired with disposable LFD, the mLAMP assay enables rapid visual detection of assay results in a matter of minutes. The result contributes to the mLAMP assay being highly suitable for coinfection screening, particularly in field conditions., (© 2024. The Author(s).)

Hepatocellular carcinoma (HCC) is a malignant tumor. It is estimated that approximately 50-80% of HCC cases worldwide are caused by hepatitis b virus (HBV) infection, and other pathogenic factors have been shown to promote the development of HCC when coexisting with HBV. Understanding the molecular mechanisms of HBV-induced hepatocellular carcinoma (HBV-HCC) is crucial for the prevention, diagnosis, and treatment of the disease. In this study, we analyzed the molecular mechanisms of HBV-induced HCC by combining bioinformatics and deep learning methods. Firstly, we collected a gene set related to HBV-HCC from the GEO database, performed differential analysis and WGCNA analysis to identify genes with abnormal expression in tumors and high relevance to tumors. We used three deep learning methods, Lasso, random forest, and SVM, to identify key genes RACGAP1, ECT2, and NDC80. By establishing a diagnostic model, we determined the accuracy of key genes in diagnosing HBV-HCC. In the training set, RACGAP1(AUC:0.976), ECT2(AUC:0.969), and NDC80 (AUC: 0.976) showed high accuracy. They also exhibited good accuracy in the validation set: RACGAP1(AUC:0.878), ECT2(AUC:0.731), and NDC80(AUC:0.915). The key genes were found to be highly expressed in liver cancer tissues compared to normal liver tissues, and survival analysis indicated that high expression of key genes was associated with poor prognosis in liver cancer patients. This suggests a close relationship between key genes RACGAP1, ECT2, and NDC80 and the occurrence and progression of HBV-HCC. Molecular docking results showed that the key genes could spontaneously bind to the anti-hepatocellular carcinoma drugs Lenvatinib, Regorafenib, and Sorafenib with strong binding activity. Therefore, ECT2, NDC80, and RACGAP1 may serve as potential biomarkers for the diagnosis of HBV-HCC and as targets for the development of targeted therapeutic drugs., (© 2024. The Author(s).)

Background: The near total absence of routine Hepatitis Delta Virus (HDV) screening in many countries in sub-Saharan Africa is a major challenge to understanding the burden of HDV in the region., Aim: To evaluate Hepatitis Delta Virus screening practices and associated factors among clinicians in Nigeria., Methods: A cross-sectional study was conducted in June-July 2022, in which a self-administered questionnaire that inquired about HDV awareness, screening practices, and treatment options was shared electronically with consenting clinicians practicing in Nigeria. At the end of the survey, data was analyzed using descriptive and inferential statistics. The level of significance was set at 0.05., Results: At the end of the survey, 210 of the 213 responses retrieved from respondents were analyzed. The respondent's mean age was 38.60 ± 7.27 years with a male-to-female ratio of 1:2.5. They comprised 13.8% gastroenterologists and 86.2% respondents in other areas of clinical medicine. The study showed that 89.5% of the respondents knew that HDV infection occurs only in hepatitis B virus (HBV)-infected individuals. Most (91.4%) respondents do not screen for HDV in chronic HBV patients, mainly due to the non-availability of screening tools and lack of awareness of any screening test for HDV. Research interest was reported as the reason for screening among clinicians who had ever screened for HDV. Pegylated interferon was the main regimen used for treatment by 87.5% of respondents. About 2% did not know treatment options for HDV. A significant association between knowledge of HDV infection and area of specialty, as well as the nature of medical practice was noted (P = 0.008 and 0.013, respectively)., Conclusion: The study showed a high level of awareness of HDV dependency on HBV, for natural infection to occur. However, it documented very minimal HDV screening in clinical settings and factors affecting screening among clinicians., (Copyright © 2024 Copyright: © 2024 Nigerian Journal of Clinical Practice.)

Deaths from liver cancer are on the rise and disproportionately affect minority racial/ethnic groups. In this study, we examined associations between physicians' recommendations for hepatitis B virus (HBV) and hepatitis C virus (HCV) screening and sociodemographic and lifestyle factors among minority populations in the areas of Greater Philadelphia and New York City. Using Poisson regression with robust variance estimation, we evaluated potential associations for 576 Hispanic American (HA), African American (AA), and Asian Pacific American (APA) adults, using blood tests as an outcome measure, with adjustment for sociodemographic factors We found that APAs (34.2%) were most likely to have a physician recommend HBV and HCV screening tests (34.2% and 27.1%, respectively), while HAs were least likely to receive an HBV recommendation (15.0%) and AAs were least likely to receive an HCV recommendation (15.3%). HAs were significantly likely to have never received a blood test for either HBV or HCV (RR = 1.25, 95% CI: 1.05, 1.49). APAs were significantly more likely to receive a screening recommendation for HBV (RR = 1.10, 95%CI: 1.01, 1.20) and to have a blood test (RR = 1.57, 95% CI: 1.06, 2.33). Our findings show that, among HAs, AAs, and APAs, physician recommendations are strongly associated with patients undergoing blood tests for HBV and HCV and that minority populations should increasingly be recommended to screen for HBV and HCV, especially given their elevated risk., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

We aimed to compare the NeuMoDx HBV Assay with the artus HBV Assay using residual plasma samples and to evaluate the discordant results. The study included 200 patient samples analyzed with the NMD assay and stored at -80 °C. Samples were analyzed by artus in 2023. Discordant results were evaluated by cobas 6800 HBV DNA Test. Excellent agreement was found between both tests. Of the 100 samples that were HBV DNA negative by NMD, 93 were negative and 7 were positive by artus. With the Cobas test, 5 samples were positive. Of the100 HBV DNA positive samples detected by NMD, 99 were positive with the artus assay. This sample was also HBV DNA negative by the Cobas test. The sensitivity and specificity of NeuMoDx were found 93 % and 99 %, respectively. There was excellent qualitative agreement and strong quantitative correlation between the NeuMoDx and artus assays for HBV DNA detection and quantitation., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objectives: Widespread testing and treatment are essential to eliminate hepatitis B virus (HBV) infection as a public health concern. However, in resource-limited countries, access to HBV PCR is limited. In this study, we developed a quantitative HBV PCR assay on open molecular platforms and evaluate its performance in diagnosing clinically significant HBV DNA thresholds as defined by the WHO (2000 IU/mL, 20 000 IU/mL, and 200 000 IU/mL)., Methods: We implemented our HBV PCR test in seven African and Asian countries and France, using either an in-house laboratory method or a European conformity for in vitro diagnostic (CE-IVD) marked version of the PCR (Generic HBV Charge Virale, Biocentric). Results were compared with reference tests (Roche Cobas AmpliPrep/Cobas TaqMan and Abbott RealTime on Abbott m2000)., Results: There was a good agreement between the HBV DNA results of 1015 samples tested by the PCR on open polyvalent platforms and the results from reference tests (mean difference (bias ± standard deviation [SD]): -0.3 ± 0.7 log 10 IU/mL and -0.2 ± 0.9 log 10 IU/mL when compared with Roche and Abbott tests, respectively). Kappa-Cohen agreements between the HBV PCR on open polyvalent platforms and the Roche/Abbott assays appeared almost perfect for HBV DNA levels ranged from >20 000 to 200 000 IU/mL and >200 000 IU/mL, substantial and moderate for HBV DNA levels ranged from 2000 to 20 000 IU/mL when compared with Abbott and Roche, respectively. The assay's performance was consistent across genotypes A, B, C, D, and E., Discussion: This field evaluation showed that our HBV PCR test is a valuable alternative to proprietary PCR systems. PCR assays on open platforms contribute to expanding clinical laboratory solutions for diagnosing individuals who meet the viral load criteria for antiviral therapy (>20 000 IU/mL) and mother-to-child prophylaxis (>200 000 IU/mL)., (Copyright © 2024. Published by Elsevier Ltd.)

Objectives: The UK signed up to the 2016 global health strategy to eliminate viral hepatitis as a public health problem. Effective monitoring of hepatitis testing outcomes is required to track progress against targets. National reporting does not include hepatitis B and hepatitis C infections (HBV/HCV) detected by online sexually transmitted infection (STI) testing services (e-services). We identify HBV/HCV infection rates among individuals using Sexual Health London (SHL), a large e-service., Methods: SHL e-records of individuals receiving reactive HBsAg and/or HepCAb screening results between 1 January 2021 and 1 January 2022 were reviewed. Only at-risk groups are offered HBV/HCV testing, with risks captured via an online triage/consultation. Roche Cobas e801 HBV/HCV screening assay uses a cut-off index of reactivity (COI) to categorise results: low reactive (COI >1-9) and reactive (COI ≥10). SHL refers individuals with any reactive result for confirmatory testing (CT) at a sexual health clinic that provides hepatitis outpatient management. Clinic staff performing the CT access the shared SHL e-record and electronically take over the patient's care., Results: 67, 718 HBV and 61 064 HCV tests were performed, representing 16% of all kit returns. HBV reactivity was 1.4% (922/67 718): 474 low-reactive, 302 reactive and 146 unconfirmed-reactive. HCV reactivity was 0.3% (163/61 064): 53 low-reactive, 99 reactive and 11 unconfirmed-reactive.Among individuals with reactive (COI ≥10) screening HBV results, 85% results confirmed, 12% negative and 3% unknown. For HCV, 79% results confirmed, 13% negative and 8% unknown. 57 out of 57 new HBV/HCV infections were electronically transferred. HBV prevalence was 299/67 718 (0.4%). The rate of previously undiagnosed cases detected was 40 out of 67 338 (0.06%) for HBV and 17 out of 61 016 (0.03%) for HCV., Conclusions: 16% of SHL service users received targeted testing for hepatitis in 2021. Testing volumes significantly exceeded and new HBV/HCV diagnosis rates were similar to those reported by sentinel laboratory surveillance. 100% new infections transitioned to care, demonstrating effective integration between online and local sexual health services., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Hepatitis B virus (HBV) reactivation (HBVr) induced by chemotherapy in patients with resolved or chronic infection can lead to severe consequences. Despite recommendations, rates of HBV screening before chemotherapy are low due to poor recognition of risk factors by clinicians. The aim of the study is to assess whether routine HBV screening using universal HBV screening on chemotherapy orders (CO) could reduce HBVr incidence., Methods: This is a 1-year retrospective single-center observational study of patients who received intravenous chemotherapy post implementation of CO. We compared the incidence of HBVr in three groups of patients: those screened through CO (group 1), those screened by the medical team (group 2), and those not screened (group 3)., Results: On a total of 1374 patients, 179 of 206 patients were screened as requested on CO (group 1) and 421 by the medical team (group 2), whereas 747 patients were not screened (group 3). Only one HBVr occurred, and no difference was seen on the incidence of HBVr between group 1 and group 3 (0% vs 0.1%; p = 1.00), probably because of a lack of follow-up after chemotherapy. Follow-up for HBVr was imperfect in group 1 and group 2 (16.7% vs 5.6%; p = 0.32). Screening was done for 92% of patients on anti-CD20 therapy. In group 3, 89 patients had ALT elevation during chemotherapy but only 17 (19%) were tested for HBVr., Conclusion: Systematic HBV detection requested on CO is an effective way to obtain a high percentage of patients with adequate screening, particularly when chemotherapy is at high risk of HBVr. Nevertheless, this screening method do not guarantee optimal follow-up and requires improvements., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

The detection of hepatitis B surface antigen (HBsAg) is critical in diagnosing hepatitis B virus (HBV) infection. However, existing clinical detection technologies inevitably cause certain inaccuracies, leading to delayed or unwarranted treatment. Here, we introduce a label-free plasmonic biosensing method based on the thickness-sensitive plasmonic coupling, combined with supervised deep learning (DL) using neural networks. The strategy of utilizing neural networks to process output data can reduce the limit of detection (LOD) of the sensor and significantly improve the accuracy (from 93.1%-97.4% to 99%-99.6%). Compared with widely used emerging clinical technologies, our platform achieves accurate decisions with higher sensitivity in a short assay time (∼30 min). The integration of DL models considerably simplifies the readout procedure, resulting in a substantial decrease in processing time. Our findings offer a promising avenue for developing high-precision molecular detection tools for point-of-care (POC) applications.

Hepatitis B virus (HBV) acts as a severe public health threat, causing chronic liver diseases. Although the quantified evaluation of HBV infection can be obtained by estimating the capacity of the HBV DNA genome, it still lacks an effective and robust detection method without using enzymes or chemical labeling. Herein, we have designed a binary split fluorescent DNA aptasensor (bsFDA) by rationally splitting the lettuce aptamer into two functional DNA short chains and utilizing the HBV DNA segment complementary sequences (HDs). In this strategy, the bsFDA has been investigated to specifically recognize the HDs, forming a triplex DNA with the lettuce aptamer structure. Meanwhile, the turn-on fluorescence of bsFDA is obtained upon formation of a fluorescent complex between DFHO and the triplex DNA structure, allowing the enzyme-free, label-free, fast-responsive, and reliable fluorescence readout for detecting HDs and the potential HDs mutants. Moreover, bsFDA has been applied for spiked HDs analysis in different real matrixes, including human serum and cell lysate. The satisfactory recovery rates and reproducibility of the bsFDA reveal its potential detection efficacy for HDs analysis in biological samples. Overall, bsFDA holds great potential in developing functionalized aptasensors and realizing viral genome analysis in biological research.