Hepatitis B Surface Antigen Screening Research Articles

Factors Related to Compliance with HBsAg Screening Among Pregnant Mothers in Bengkulu Province

Background:The low number of Hepatitis B surface antigen (HBsAg) screenings indicates that the people of Bengkulu Province have a limited understanding of the importance of such examinations. In Bengkulu, 1.61% of pregnant women, or approximately 47.550 individuals, are positive for hepatitis B infection. This is partly due to the low rate of HBsAg screening among pregnant women. Objective:To determine the prevalence of HBsAg screening compliance among pregnant women and the factors influencing it. Method:This research utilized a cross-sectional study design. A multistage random sampling method was used to select 488 pregnant women from nine districts and one city in Bengkulu Province. Data analysis was performed using multiple logistic regression. Results:The findings showed a non-compliance rate for the HBsAg test of 77.87% (95% CI: 73.95-81.34). Factors associated with non-compliance included maternal perception (adjusted OR: 7.01, 95% CI: 3.62–13.57), quality of life (adjusted OR: 6.19, 95% CI: 2.98–12.88), husband's support (adjusted OR: 2.16, 95% CI: 1.11–4.18), and health worker support (adjusted OR: 3.68, 95% CI: 1.91–7.08). Conclusion:It is crucial for pregnant women to increase their awareness of the importance of HBsAg screening, supported by their husbands, with additional counseling on the negative impacts of hepatitis B during pregnancy. Cultural perceptions should be addressed to foster more positive attitudes. Enhanced collaboration between health service providers, traditional or community leaders, and the public is necessary to improve overall public health outcomes. Keywords: HBsAg screening compliance; health literacy; quality of life; perception; husband support; health worker support

Investigating factors associated to HBV/HIV co-infected patients in antiretroviral treatment clinic, in Northeast Ethiopia.

Existing research in Ethiopia has primarily focused on the individual epidemiology of HIV and HBV, often overlooking the intricate dynamics of co-infection. This study aims to address this gap by comprehensively exploring the prevalence of HBV and HIV co-infection and the associated factors influencing co-infection rates within the specific context of ART clinics. The existing study provides limited insights into the unique challenges posed by this dual infection in the Ethiopian population receiving ART. An institutional-based cross-sectional study was conducted among people living with HIV aged 18 years and above attending ART clinics in northeast Ethiopia from April to May 2022. A sample size of 350(97% response rate) participants was selected by using a systematic random sampling method. Data were collected using a pre-tested interviewer-administered structured questionnaire. Data was entered into Epi Data version software and was exported to SPSS version 25 for further analysis. Descriptive statistics using Frequency, proportion, and summary measures were done. Binary logistic regressions were done to identify independent variables associated with HBV infection among HIV patients. A P-value less than 0.05 and adjusted odds ratio with a 95% confidence interval non-inclusive of one was considered statistically significant. The prevalence of Hepatitis B Surface Antigen (HBsAg) was identified constituting 7.14% of the study population. Females [AOR] 0.14; 95% Confidence Interval [CI] [0.041-0.478]). Participants with an educational status of only reading and writing (AOR 8.7; 95% CI [1.143-66.5]). Single individuals (AOR 2.04; 95% CI [1.346-28.6]) were associated factors. Moreover, participants with a viral load exceeding 1000 copies/ml were 6.5 times more likely to be infected with HBV compared to those with undetectable viral loads (AOR 6.53, 95% CI [1.87-22.72]). Additionally, individuals with a CD4 count ranging from 351 to 500 cells/ml were 1.2 times more likely to be infected with HBV compared to those with a CD4 count of 500 cells/ml or above (AOR 10.4, 95% CI [1.28-85]). The prevalence of HBV infection was found to be intermediate in HIV-infected patients in the study area. Being male, marital status of single and divorced, educational level was only read and written, current viral load of > 1000 copies/ml &<1000 copies/ml, and current CD4 < 250 cells/ml were found statistically associated factors for HBV infection. Thus, we recommend the provision of routine screening for HBsAg and appropriate treatment with accurate information on risk factors for HBV to improve quality of life and reduce morbidity.

Detekcija dobrovoljnog darivatelja krvi s preboljelom infekcijom hepatitisa Bprikaz bolesnice

Introduction: Hepatitis B is liver inflammation caused by the hepatitis B virus, with more than 250 million documented cases worldwide in the chronic form of infection. Markers of hepatitis B infection can be measured in the blood during or after infection and may be present in the form of specific hepatitis B surface antigen (HBsAg) or antibodies to hepatitis B surface (HBs), core (HBc), or envelope (HBe) antigens. Case report: A 42-year-old female, who successfully donated blood for the first time, underwent mandatory serological and molecular testing along with additional testing for other hepatitis B markers. Standard screening showed the absence of HBsAg in the blood, but additional serological testing confirmed the presence of total antibody to hepatitis B core antigen (anti-HBc). Upon repeated reactive results, the sample was sent for confirmatory testing to a reference center. After obtaining all the results, it was determined that the voluntary blood donor had the presence of anti-HB cand HBs antibodies, indicating a prior contact with the hepatitis B virus. While serological tests suggested a resolved hepatitis B infection, the possibility of a persistent liver infection could not be ruled out, despite the absence of detectable hepatitis B virus DNA in the blood. Therefore, the individual has been permanently excluded from the list of potential blood donors. Conclusion: Mandatory serological and molecular testing of blood donors for the hepatitis B virus successfully detects potentially infected individuals and carriers of hepatitis B markers. However, additional testing further enhances the safety of both recipients and blood donors. This case study highlights the importance of comprehensive screening for hepatitis B markers, as relying solely on HBsAg screening would not have identified the voluntary blood donor as a resolved hepatitis B case. Thus, comprehensive screening ensures a higher level of safety in blood transfusion and contributes to overall healthcare protection.

Implementation of Strategies to Prevent Mother-to-child Transmission of Hepatitis B Virus Infection, Thailand, 2016–2017

Mother-to-child transmission (MTCT) of hepatitis B virus can cause chronic liver disease. Thailand aimed to eliminate MTCT of hepatitis B virus by 2025. Strategies include hepatitis B surface antigen (HBsAg) screening for pregnant women, antiviral therapy for infected mother, hepatitis B birth dose vaccination (HepB-BD), HBV immunoglobulin (HBIG) administration and post-vaccination serologic testing (PVST) for infants born to HBsAg-positive mother. The objectives of this study were to assess the management of HBsAg-positive mothers and their infants. We reviewed medical records of HBsAg-positive pregnant women and their infants born during 1 Jan 2016–31 Dec 2017 at 14 hospitals in seven provinces to assess the percentage of women who were tested and treated for HBV and the percentage of infants born to them who received HepB-BD, HBIG and underwent PVST. All 69,303 pregnant women were screened for HBsAg and 1,179 (1.7%) were HBsAg positive. Of 1,179 HBsAg-positive women, 219 (18.6%) were tested for hepatitis B e-antigen (HBeAg) and 85 (38.8%) were HBeAg positive; 29 (2.5%) were tested for HBV DNA and 14 (48.3%) had viral load ≥200,000 IU/mL. Of 90 women eligible for antiviral therapy, 16 (17.8%) received treatment. Among 1,144 infants with available records, HepB-BD and HBIG coverage was 99.3% and 45.8%. Of 966 children with follow-up records, 12.2% underwent PVST and all were HBsAg negative. In conclusion, while the coverage of maternal HBsAg screening and infant HepB-BD was high, few women received follow-up testing and treatment. HBIG administration for infants was low and PVST rate still needed improvement.

Intrauterine Transmission of Hepatitis B Cannot Be Ruled Out by A Single Negative Hepatitis B e Antigen (HBeAg) Result among Hepatitis B Surface Antigen (HBsAg) - Positive Pregnant Women

BACKGROUND: The risk factors for intrauterine transmission of hepatitis B virus (HBV) in hepatitis B surface antigen (HBsAg)-positive pregnant women are poorly understood. Numerous factors are considered to be involved, including placental barrier, obstetric environment, high viral load, and positivity of hepatitis B e antigen (HBeAg). This study was conducted to investigate the role of placenta barrier, clinical, and viral factors in intrauterine transmission of HBV.METHODS: A cross-sectional study was conducted involving 1,353 pregnant women who underwent HBsAg screening. Eighty-four (6.2%) women were detected as HBsAg positive and were examined for HBsAg level, anti-HBs, anti-HBc, HBeAg/hepatitis B e antibody (anti-HBe) status, and HBV DNA presence in cord blood. Quantitative HBV DNA was analyzed using real-time polymerase chain reaction (PCR).RESULTS: Eighty-four of 1,353 subjects were HBsAg-positive. HBV DNA was positive in 28/84 (33.7%) maternal sera, 19/79 (24.05%) placental specimens, and 9/83 (10.84%) in cord blood. There were significant associations between HBV DNA in maternal serum (p=0.000) and placental tissue (p=0.000) with HBV DNA in the cord blood. No clinical factors were associated with HBV DNA transmission in cord blood. Sixty percent of viral load &gt;5.3 log10 copies/mL were found in the cord blood, of which 43.8% HBeAg positive and 3.1% HBeAg negative.CONCLUSION: Reduced transmission via compartments established the placenta’s barrier function in mother-to-child transmission. A high maternal viral load and positive HBeAg were risk factors for intrauterine transmission, while negative HBeAg still has the possibility of transmission.KEYWORDS: mother-to-child transmission, hepatitis B virus, intrauterine

Clinical trial and performance evaluation of the Wantai HBsAg (CMIA) diagnostic kit for screening blood donors in China

In China, according to the ‘Technical Operating Procedures for Blood Stations (2019 Edition),’ blood stations are authorized to utilize Chemiluminescence Immunoassay (CLIA) to detect pathogen markers linked with transfusion-transmissible infections. However, currently, there is no approved CLIA reagent for the screening of blood-borne diseases in China, specifically for the detection of Hepatitis B surface antigen. The objective of this research project is to conduct a comprehensive evaluation of the performance of the Wantai Chemiluminescent Microparticle Hepatitis B surface antigen reagent. This study evaluates the performance of the Wantai Chemiluminescent Microparticle Immunoassay (CMIA) on the Wan200 + analyzer in screening for Hepatitis B Surface Antigen (HBsAg) in blood samples. The clinical trial component of this evaluation is included as part of the documentation submitted to the National Medical Products Administration (NMPA) of China for the approval of blood screening reagents. The evaluation plan of this study encompasses two main components: clinical trials and performance assessment. We adopted a controlled trial design, utilizing the WanTai Chemiluminescent Microparticle Immunoassay (CMIA) on the Wan200 + analyzer and the Enzyme-Linked Immunosorbent Assay (ELISA) to screen for Hepatitis B Surface Antigen (HBsAg) in routine blood donor samples and reference serum panel samples. To ensure the accuracy of the screening, we additionally employed Abbott's ELISA reagents and HBV DNA for validation. The assessment primarily focused on key performance indicators such as sensitivity, specificity, and analytical sensitivity. Moreover, this clinical trial data has been included as part of the submission to China's National Medical Products Administration (NMPA). In the clinical trials of this study, a total of 10,470 blood donor samples underwent simultaneous testing using both CMIA and ELISA methods. Across two clinical trials, there was remarkable concordance between CMIA and the two ELISA reagents, with Kappa values exceeding 0.82. Among the 269 samples that were double-reactive in the enzyme immunoassay (ELISA) tests, CMIA exhibited a 100% reactivity detection rate. However, CMIA produced 14 and 6 false-positive results in the respective clinical trials, resulting in specificities of 99.73% and 99.89%. In contrast, the specificities for Wantai ELISA and Xin Chuang ELISA were both greater than 99.94%.When testing samples in the gray zone serum plates, CMIA's detection limit significantly exceeded that of the two ELISA assays. CMIA had a detection cutoff of 0.05 IU/mL, while the two ELISA reagents had cutoffs of 0.1 IU/mL and 0.09 IU/mL, respectively. CMIA's detection limits for the adr and adw subtypes were 0.05 IU/mL, and for the ay subtype, it was 0.1 U/mL. The detection limit for 10 HBV mutant samples was 0.5 U/mL. In 165 cases where ELISA tested negative but HBV DNA tested positive, CMIA detected 5 HBsAg-positive samples. This study evaluated the performance of the Wantai CMIA in screening for HBsAg among blood donors. The results demonstrate outstanding performance of CMIA in both clinical trials and performance assessments, detecting all true positive samples with a sensitivity of 100%. It exhibits excellent concordance with the two ELISA assays. Of particular note is its superiority in early detection of HBsAg in the screening of early-stage hepatitis B infections, reducing the window period compared to ELISA. CMIA achieves a specificity exceeding 99.73% for negative blood donors, aligning with the European Union's standards for blood screening assay specificity. In summary, Wantai's CMIA displays high sensitivity and specificity in blood donor screening, making it suitable for screening blood donors in China.

An interesting case of isolated false-negative hepatitis B surface antigen in a blood donor.

An important requirement for a hepatitis B surface antigen (HBsAg) screening assay is reliable detection of HBsAg mutant forms, especially in blood donation. Here we investigate and describe the case of an isolated false-negative result of commercial serology HBsAg screening assay of a blood donor. The current donation was routinely tested for HBsAg and hepatitis B virus (HBV) DNA in the mini-pool mode nucleic acid testing (MP-NAT of six samples), and further evaluated by individual donation ID-NAT. Finally, it was quantified and sequenced. All previous donations were found to have negative HBsAg and HBV DNA, as also the subsequent sample taken 3 months after the marked donation. The current donation of the 53-year-old unvaccinated female with 14 previous donations was initially HBsAg negative and HBV DNA (MP-NAT) positive. Further testing showed HBsAg positive using other HBV serological assays, antibodies to HBV core antigen immunoglobulin Mpositive and HBV DNA ID-NAT positive, and contained 200 IU/mL of HBV DNA. The implicated donation carried genotype D strains, subtype ayw2 (F83S, V96A, V190A, L193S, I195T, L213S, F220L). The mutations in three positions, namely amino acids T118A, P120T, and P127T, were proven subsequently. This unique mutation combination near the target epitope of one of the immunoassay monoclonals is a possible cause of the reduced analytical sensitivity of the serology assay.

Hepatitis B immunization status and risk factors of people aged 1 to 69 in Huangpu District, Shanghai, China.

China has long been with high Hepatitis B Virus(HBV) prevalence in the world. The HBV prevalence of people aged 1-59 decreased to less than 8% in 2006, and by 2020, HBsAg positive rate of children aged <5 decreased to less than <1% which was due to the free three-dose hepatitis B(HepB) immunization for newborns nationwide since 2002. Huangpu district was selected as one of the pilot areas for free Hep B vaccination in newborns since 1986, which formed an early protection in the population from mother-to-child transmission. However, the existed HBV infected people were still needed to be discovered, evaluated whether to receive antiviral therapies and intervened with health education in order to reduce the incidence of viral hepatitis related hepatocellular carcinoma (HCC) and also reach the goal to eliminate public health hazards of viral hepatitis by 2030. To know HepB immunization status among people aged 1 to 69 in Huangpu district of Shanghai, and find out risk factors changes of HBV infection. Cross-sectional study was applied to analyze the HepB immunization status and related risk factors by carrying out survey among 706 participants aged 1 to 69 years old. Blood samples were collected for detection of serological HBV markers including hepatitis B surface antigen(HBsAg), hepatitis B surface antibody(HBsAb) and hepatitis B core antibody(HBcAb). Participants with HBsAg positive were required to complete additional examinations such as alanine aminotransferase(ALT), aspartate aminotransferase(AST), total bilirubin, albumin, globulin, liver fibroscan and liver ultrasound. For participants aged 1 to 14, the positive rate of HBsAg, HBsAb and HBcAb was 0.00, 50.00 and 30.46%, respectively. The HBsAb positive rate reached a peak of 90.91% at 2 years old, and then showed a significant downward trend (χ2 = 55.612, p < 0.001). All the participants have completed three-dose Hep B vaccination, however for the second dose, those who vaccinated 30 days later than the appointed time(aged one month) got higher HBcAb prevalence than those who vaccinated on time(χ2 = 5.87, p = 0.015). Two mothers were found HBsAg positive, but there was no significant difference in children's HBcAb positive rates regardless of the mothers' HBsAg results. For participants aged 15 to 69, the positive rate of HBsAg, HBsAb and HBcAb was 4.21, 44.25 and 49.23%, respectively. Multivariate analysis for HBcAb positive among people aged 15 to 69 showed that age(50-69) and HBsAb positive were the risk factors for HBcAb positive(p < 0.05). Higher education was the protective factor for HBcAb positive(p < 0.05). After the screening for HBsAg, 22 participants were tested HBsAg positive and required additional examinations, and a total of 12 completed all the examinations. One participant was recognized as active HBV infection without antivirus treatment. Among the 12 participants, 2 have received antiviral treatment before and 4 had a history of HBV infection in family members. In this study, HBsAg positive rate of those who aged 1 to 14 was 0.00%, which indicated that the HepB immunization has achieved a lot in protecting children from being infected. However, failing to get timely Hep B vaccination could be an influencing factor for HBcAb positive in children. As a result, additional tests for HBV DNA could be done to specify an HBV infection and more attention should be paid to the timeliness of Hep B vaccination in the next step. The HBcAb positive rate of people aged 1 to 69 was relatively higher than that of other provinces. Despite of the limited participants with full examinations, we should still put emphasis on HBV treatment and the possibility of transmission within families.

Risk of early horizontal transmission of hepatitis B virus in children of uninfected mothers in sub-Saharan Africa: a systematic review and meta-analysis

Sub-Saharan Africa is highly endemic for hepatitis B virus (HBV); historically, most people were exposed during childhood through vertical or horizontal transmission. Although all African countries now provide a three-dose infant hepatitis B vaccination starting at age 6-8 weeks, only a third of African countries have introduced birth dose (HepB-BD) vaccine. Adding HepB-BD is fundamental to prevent vertical transmission, but its effectiveness in preventing horizontal transmission, compared with the three-dose infant vaccination alone, is unknown. We aimed to estimate the risk of early horizontal transmission in children of hepatitis B surface antigen (HBsAg)-negative mothers in sub-Saharan Africa stratified according to the vaccination schedule. In this systematic review and meta-analysis we searched MEDLINE, Global Health, Embase, African Index Medicus and African Journals Online from their inception to Oct 24, 2022, for studies reporting HBsAg or HBV DNA, or both, in children (aged 0-5 years) of HBsAg-negative mothers. We excluded studies if children were only tested at birth. Two reviewers independently screened the titles and abstracts of all articles and data were extracted using a standardised pre-piloted data extraction sheet, and authors were contacted if any important information was missing. The primary outcome was the risk of HBV infection in children of HBsAg-negative mothers, stratified by vaccination schedule (no vaccination, first dose at 6-8 weeks, or first dose at birth). We pooled the child risks of HBsAg or HBV DNA-positivity from the age of 0 years to 5 years via a random-effect meta-analysis using a generalised linear mixed model. The study was registered on PROSPERO, CRD42021236203. Of 8856 articles identified, 27 studies evaluating 10 003 children of HBsAg-negative mothers were included. The pooled risks of infection were 6·16% (95% CI 3·05-12·04; 155/1407) in the no vaccination group, 0·21% (0·04-1·15; 10/3425) in children who received their first dose at 6-8 weeks, and 0·05% (0·00-1·32; 3/2902) in children who received their first dose at birth. The difference was not statistically significant in children who received their first dose at 6-8 weeks and children who received their first dose at birth after adjusting for the study period, region, and maternal HIV status (test of moderators p=0·37). In children of HBsAg-negative mothers, the risk of infection might be minimal even with the vaccination starting at 6-8 weeks, without clear additional benefit from HepB-BD. When births take place at home and timely administration of HepB-BD is challenging, antenatal HBsAg screening and selective HepB-BD might allow efficient allocation of resources to mother and child pairs at high risk compared with universal HepB-BD. None. For the French translation of the abstract see Supplementary Materials section.

Strategies to Prevent Mother-to-child Transmission of Hepatitis B Virus.

Mother-to-child transmission (MTCT) of hepatitis B virus (HBV) is the primary cause of chronic HBV infection worldwide. MTCT prevention and antiviral treatment of infected individuals could eliminate this public health burden. Antiviral treatment of hepatitis B surface antigen (HBsAg)-positive pregnant women and immunoprophylaxis with HBV vaccine and hepatitis B immune globulin are the most effective strategies to interfere with MTCT of HBV. However, for worldwide application of those strategies, feasibility, availability, cost, safety, and effectiveness should be considered. Cesarean section and breastfeeding avoidance in hepatitis B e antigen-positive mothers with a high viral load and without antiviral therapy during pregnancy could be an option, but more supporting evidence is needed. HBsAg screening of all pregnant women is recommended when initiating antiviral therapy and immunoprophylaxis for MTCT prevention, except in areas with limited resources. Timely HBV vaccination series administered soon after birth might be the mainstay of prevention. This review aimed to provide a concise update on the effectiveness of available strategies to prevent MTCT of HBV.

Prevalence of Occult Hepatitis B Virus Infection in Blood Donors with Negative ID-NAT in Switzerland

Introduction: Screening of hepatitis B surface antigen (HBsAg) and individual-donation nucleic acid amplification testing (ID-NAT) of blood donors have become standard to detect hepatitis B virus (HBV) infection. However, there is still a residual risk of HBV transmission by blood components of donors suffering from occult HBV infection (OBI). Therefore, many countries implemented universal testing of anti-HBV core antigen (anti-HBc) antibodies in order to increase blood safety. In Switzerland, anti-HBc testing is not part of the routine blood donor-screening repertoire. Therefore, we sought to assess prevalence of donors with OBI in a Swiss blood donor collective. Methods: Blood donations were prospectively investigated for the presence of anti-HBc antibodies during two time periods (I: all donors, March 2017; II: first-time donors only, April 2017 until February 2018). Anti-HBc-positive findings were confirmed by an anti-HBc neutralization test. Discarded plasma samples of anti-HBc-confirmed positive donors were ultracentrifuged and subsequently retested by regular HBV-ID-NAT to search for traces of HBV. Results: During time period I, 78 (1.6%) individuals out of 4,923 donors were confirmed anti-HBc-positive. Sixty-nine (88%) anti-HBc-positive samples were available and processed by ultracentrifugation followed by repeat HBV-ID-NAT. Four samples (5.8%) were found positive for HBV DNA. Sixty-five (94.2%) samples remained HBV NAT-negative upon ultracentrifugation. During time period II, 56 (0.9%) donor samples out of 6,509 exhibited anti-HBc-confirmed positive. Fifty-five (98%) samples could be reassessed by HBV-ID-NAT upon ultracentrifugation. Three (5.5%) samples contained HBV DNA and 52 (94.5%) samples remained HBV NAT-negative. Conclusion: Overall, we detected 7 viremic OBI carriers among 11,432 blood donors, which tested negative for HBV by standard HBV-ID-NAT and HBsAg screening. In contrast, OBI carriers showed positive anti-HBc findings which could be confirmed in 83.8% of the cases. Thus, OBI might be missed by the current HBV screening process of Swiss blood donors. We suggest to review current HBV screening algorithm. Extended donor screening by anti-HBc testing may unmask OBI carriers and contribute to blood safety for the recipient of blood products.

Incidence and Influencing Factors of New Hepatitis B Infections and Spontaneous Clearance: A Large-Scale, Community-Based Study in China.

Background: Hepatitis B surface antigen (HBsAg) is widely used in hepatitis B screening, and HBsAg seroclearance indicates hepatitis B eradication. Few studies have explored the incidence of and determinants for spontaneous seroclearance using a long-term follow-up cohort study. Our research aimed to examine the incidence of and influencing factors for hepatitis B virus infection and spontaneous clearance of HBsAg from a large-scale cohort in China.Methods: A total of 151,926 resident individuals in Tongxiang underwent HBsAg screening at least thrice in a 7-year period. Serum samples collected at baseline and follow-up examinations were tested for HBsAg. Cox proportional hazard models were used to analyze determinants of HBsAg seroclearance and persistent HBsAg presence.Results: Among the 151,926 participants, new hepatitis B infections occurred in 4,497 participants, yielding an incidence rate of 571.38 per 100,000 person-years. The incidence rate for males was higher than that for females. In the multivariate Cox regression analysis, female gender, alcohol drinking history, hepatitis family history and middle-age group were predictors for persistent positive HBsAg status.Conclusions: The incidence rate of new hepatitis B infections was 571.38 per 100,000 person-years. Male and aged people in this community cohort have a higher infection rate. Alcohol drinking and hepatitis family history were risk factor leading to chronic infection. Female and middle-aged people were prone to persistent positive HBsAg status.

Prevalence of Hepatitis B and C Virus Infections: Influence of National Health Care Policies and Local Clinical Practices

Background: Because reliable epidemiological data are necessary to eliminate hepatitis B and C virus (HBV and HCV) infections, factors influencing their prevalence should be determined. This study aimed to disclose practical issues that affect the prevalence of these viral infections.Material/MethodsAll medical records with laboratory findings during 2016 to 2018 were reviewed, and all relevant data were extracted. All HBV and HCV infections were followed within these 3 years and investigated in detail.ResultsThe total number of records was 103 197, with a male to female ratio of 1: 1.4. Hepatitis B surface antigen (HBsAg) was tested in 12 934 cases, with a male to female ratio of 1: 2.6. Anti-HCV antibody (anti-HCV Ab) testing was done in 475 cases (53% male). The seroprevalence of HBV and HCV was 5.2% and 4.4%, respectively. Chronic HBV and HCV infections and their life-threatening complication, liver cancer, were highly detected in men aged 41–60 years.ConclusionsHBsAg was highly screened in women owing to the nationwide implementation of the universal HBsAg screening in pregnant women to prevent vertical transmission. Screening for anti-HCV Ab was neglected, probably due to lack of vaccine and high costs of anti-HCV drugs, which most people in low- to middle-income countries generally cannot afford. Local practices under national health care policies and limited budget and resources can cause underestimation of the prevalence of the HBV and HCV infections and persistent transmission of these viruses owing to unidentified cases.

Evaluation of a universal hepatitis B vaccination program and antenatal screening for hepatitis B surface antigen: Results from a real-world study 2015–2016

Background and AimsUniversal vaccination against hepatitis B virus (HBV) in infancy was implemented in Israel in 1992. This population-based study aimed to evaluate the coverage rate and cost-benefit of the HBV vaccination program among infants in Israel and the Hepatitis B surface antigen (HBsAg) status in their mothers. MethodsUsing the database of a health maintenance organization with 2 million members, we retrospectively identified, all the infants born in 2015–2016 and their mothers. Maternal data collected included age, ethnicity, country of birth and HBsAg status during pregnancy. HBV vaccination coverage among infants was calculated. A cost-benefit analysis of the HBV vaccination program was conducted based on the actual costs of HBV infection treatments in all HBsAg positive mothers. ResultsOur cohort included 72,792 mothers who gave birth to 77,572 live infants. A total of 71,107 (97.7%) mothers were screened for HBV during pregnancy, of them 124 (0.2%), who gave birth to 132 infants were HBsAg positive. HBV vaccination coverage rates were 94%, 93% and 89%, for the first, second and third dose, respectively. Birth dose coverage of 95% among infants born to HBsAg positive mothers was significantly higher compared to HBsAg negative or unscreened mothers (p < 0.001). The percentage of HBsAg positivity among mothers who were born in Israel, the Former Soviet Union or Ethiopia, were 0.1%, 0.8% and 5%, respectively (p < 0.001). Ethnic differences were not found between HBsAg positive and HBsAg negative mothers. Calculated benefit-to-cost ratios were 1.24:1 and 4.15:1, with and without antenatal HBsAg screening, respectively. ConclusionsThe Israeli vaccination program against HBV infection is epidemiologically and economically justified. High coverage rates among infants born to HBsAg positive mothers reflect very good adherence to the vaccination program and antenatal screening. Higher HBsAg positivity rates among immigrant mothers identify a high-risk population for HBV infection.

Assessment of hepatitis B surface antigen negative blood units for HBV DNA among replacement blood donors in a hospital based blood bank in Nigeria.

Hepatitis B virus infection is one of the greatest threats to blood safety all over the world. The laboratory algorithm based on only the detection of hepatitis B surface antigen (HBsAg) leaves a gap for infected HBsAg negative donors to donate blood during the "window period" (WP) and late stages of infection. To estimate the frequency of the presence of HBV deoxyribonucleic acid (DNA) in HBsAg negative blood units screened using two different assays for HBsAg in a high endemic region. Frozen serum aliquot of 100 replacement blood donors who donated blood units that were HBsAg negative were retrieved and tested for HBV DNA. Sample positive for HBV DNA was sequenced by Sanger's method, genotyped and the viral load was determined. One sample (1%) was positive for HBV DNA. The HBV viral load of the sample was 768,000 IU/ml. The partial S-gene of the Hepatitis B virus isolated was genotype E using the NCBI viral genotyping tool. There is still a risk of HBV infected blood unit escaping detection when donor testing is limited to HBsAg screening. The use of NAT which can substantially reduce HBV infected blood donors from the donor pool should be considered.

Cost-Effectiveness of 1-Time Universal Screening for Chronic Hepatitis B Infection in Adults in the United States.

An estimated 862 000 to 2.4 million people have chronic hepatitis B infection (CHB). Hepatitis B screening is recommended for pregnant women and populations with increased CHB risk. However, diagnosis rates remain low, with only 33% of people with CHB aware of their infection. This study aimed to assess the cost-effectiveness of universal adult screening for CHB. We used a Markov model to calculate the costs, population health impact, and cost-effectiveness of 1-time universal screening and CHB monitoring and treatment compared with current practice. Sensitivity analysis was performed on model parameters to identify thresholds for cost-saving or cost-effectiveness based on a willingness to pay of $50 000/quality-adjusted life-year. The analysis assumed testing would be performed during routine healthcare visits and that generic tenofovir or entecavir would be dispensed for treatment. Testing costs were based on Medicare reimbursement rates. At an estimated 0.24% prevalence of undiagnosed CHB, universal hepatitis B surface antigen (HBsAg) screening in adults aged 18-69 years is cost-saving compared with current practice if antiviral treatment drug costs remain below $894/year. Compared with current practice, universal screening would avert an additional 7.4 cases of compensated cirrhosis, 3.3 cases of decompensated cirrhosis, 5.5 cases of hepatocellular carcinoma, 1.9 liver transplants, and 10.3 hepatitis B virus-related deaths at a saving of $263 000/100 000 adults screened. Universal HBsAg screening of adults in the US general population for CHB is cost-effective and likely cost-saving compared with current CHB screening recommendations.

Acceptance of antiviral treatment and enhanced service model for pregnant patients carrying hepatitis B.

A service model was established for pregnant women with positive screening results for hepatitis B surface antigen (HBsAg) at Queen Mary Hospital in Hong Kong. All women were offered a blood test for hepatitis B virus (HBV) DNA level during the first antenatal visit. Women with HBV DNA levels of ≥200 000 IU/mL received counselling from hepatologists regarding treatment with antenatal tenofovir disoproxil fumarate (TDF) 300 mg daily. This retrospective review included women attending our antenatal clinic who exhibited positive HBsAg screening results from 15 May 2017 to 31 December 2019. The proportions of women with positive HBsAg, DNA test acceptance, hepatological review, and TDF acceptance during pregnancy were reviewed. In total, 375 (2.9%) of 13 082 pregnant women had positive HBsAg screening results. Blood tests for HBV DNA and hepatological reviews were offered to 273 women who had not undergone hepatological review prior to pregnancy; the acceptance rate was 97.8%. Sixty (22.6%) pregnant women were hepatitis B carriers with high viral loads of ≥200 000 IU/mL. Among 58 women with high viral loads, 57 received antenatal counselling regarding TDF and 56 (96.6%) agreed to take the drug; 92.9% of these 56 women had commenced TDF at or before 32 weeks of gestation. This study indicated broad acceptance of HBV DNA tests by pregnant women. Triage allowed early review and commencement of antiviral medication. This service model serves as a framework for enhanced antenatal service to prevent mother-to-child-transmission in public maternity units.

Prevalence of hepatitis B virus infection and its associated factors among 15,461 pregnant women in Yunnan province, China

PurposeChina has the world's largest burden of hepatitis B virus (HBV) infection. However, there are few studies reported on the latest prevalence of hepatitis B surface antigen (HBsAg) among pregnant women in China. We aimed to assess the prevalence of HBV infection and its associated risk factors among pregnant women in Yunnan, which is a province with relatively high prevalence of blood-borne viruses. MethodsWe conducted a cross-sectional study of 15,641 pregnant women who underwent routine antenatal screening for HBsAg in Yunnan between 2013 and 2016. Logistic regression analyses were used to examine the associations between HBV infection and risk factors. ResultsOverall, 7.89% (95% confidence interval (CI), 7.47%–8.31%) of the 15,641 pregnant women tested positive for HBsAg. Multivariable logistic regression analysis showed that advanced age (≥35 years old; adjusted odds ratio [aOR], 2.43–2.59), Hani ethnicity (aOR, 1.97; 95% CI, 1.22–3.17), unemployed women (aOR, 1.88; 95% CI, 1.30–2.72), multigravidas (aOR, 1.21; 95% CI, 1.05–1.40), and multiparas (aOR, 1.28; 95% CI, 1.10–1.49) were more likely to be infected with HBV. HBV infection was associated with cesarean section and preterm birth, with aORs of 1.31 (1.17–1.48) and 1.23 (1.00–1.51), respectively. In the subgroup analysis, the association between Hani ethnicity and HBV infection was significantly higher in women aged 35 years or older (aOR = 5.15; 95% CI, 1.51–17.55) than in women younger than 35 years of age (aOR = 1.69; 95% CI, 1.00–2.86). ConclusionsHBV infection among 15,641 pregnant women was of high-intermediate endemicity in Yunnan, China. Advanced age, Hani ethnicity, unemployment, and multigravid and multiparous statuses were associated with an increased prevalence of HBV infection. High-risk pregnant women should be paid more attention during routine antenatal examination.

The contribution of more sensitive hepatitis B surface antigen assays to detecting and monitoring hepatitis B infection.

Hepatitis B surface antigen (HBsAg) remains the main viral marker for screening and monitoring hepatitis B virus (HBV) infection. The quantification limit of most current HBsAg assays is around 0.05 IU/mL. The Lumipulse-G-HBsAg-Quant assay (Fujirebio) claims to obtain a tenfold improvement in sensitivity. This study aimed to assess the performance of this assay in detecting low HBsAg levels in clinical samples. Three panels of stored frozen samples were selected on the basis of HBV-DNA and HBsAg values obtained previously with routine techniques. Panels 1 (n=13) and 2 (n=52) consisted of DNA-positive/HBsAg-negative samples from individuals in the window period and with occult HBV infection respectively. Panel 3 comprised 23 samples with low or discrepant HBsAg screening results. All these samples were tested retrospectively with the DiaSorin and Fujirebio HBsAg assays. Sixteen out of 65 samples (25 %), initially screened HBsAg negative, were reactive only with the Fujirebio assay (median value= 0.015 IU/mL; IQR= 0.012): three (23 %) samples from panel 1 and 13 (25 %) from panel 2. Thirteen of these 16 (81 %) had HBsAg values below 0.03 IU/mL with the DiaSorin assay. In panel 3, 22 (96 %) samples were quantified successfully with the Fujirebio assay (median: 0.32 IU/mL; IQR: 1.20) and 19 (83 %) with the DiaSorin assay (median: 0.31 IU/mL; IQR: 0.65). Concentrations obtained with the two assays showed good correlations (r=0.893, Spearman). HBsAg assays with enhanced analytical sensitivity could improve HBV serological profile interpretation with possible consequences on clinical management of infected patients, and on blood transfusion safety.

Prevalence of Viremic hepatitis C, hepatitis B, and HIV infection, and vaccination status among prisoners in Stockholm County

BackgroundIdentification and knowledge of settings with high prevalence of hepatitis C virus (HCV) infection is important when aiming for elimination of HCV. The primary aim of this study was to estimate the prevalence of viremic HCV infection among Swedish prisoners. Secondary aims were to estimate the prevalence of hepatitis B surface antigen (HBsAg), human immunodeficiency virus (HIV), and the proportion who have received hepatitis B virus (HBV) vaccination.MethodsA cross-sectional study of all incarcerated persons (n = 667) at all prisons (n = 9) in Stockholm County was conducted. All prisoners are routinely offered opt-in screening for HCV antibodies (anti-HCV), HCV RNA, HBsAg, anti-HBs, anti-HBc and HIV Ag/Ab at prison in Sweden. Data on the results of these tests and the number of received HBV vaccine doses were collected from the prison medical records. The parameters of HCV RNA, anti-HCV, and occurrence of testing for HCV were analysed in multiple logistic regression models in relation to age, sex and prison security class.ResultsThe median age was 35 (IQR 26–44) years, and 93.4% were men. Seventy-one percent (n = 471) had been tested for anti-HCV, 70% (n = 465) for HBsAg and 71% (n = 471) for HIV. The prevalence of anti-HCV, HCV RNA, HBsAg and HIV Ag/Ab was 17.0, 11.5, 1.9, and 0.2%, respectively among tested persons. The proportion of prisoners who had received full HBV vaccination was 40.6% (n = 271) among all study subjects.ConclusionsThe prevalence of viremic HCV infection among Swedish prisoners in Stockholm County was 11.5%, which is high in comparison to the general population. Therefore, when aiming for the WHO goal of HCV elimination, prisons could suit as a platform for identification and treatment of HCV infection. There is a need to increase testing for blood-borne viruses and to improve vaccination coverage against HBV in Swedish prisons.