Effectiveness of hepatitis B rapid tests toward linkage-to-care: results of a randomized, multicenter study.

OBJECTIVES: Worldwide, many infected individuals are unaware of their hepatitis B virus (HBV) status. We evaluated the effectiveness of HBV rapid testing in promoting linkage-to-care. METHODS: In 2012, volunteers were recruited from five Parisian centers. Participants were randomized 1 : 1 to receive standard serology (S) or rapid testing (VIKIA-HBsAg/Quick Profile anti-HBsAb) with confirmatory serology (R+S). The primary endpoint was percentage of individuals with appropriate linkage-to-care (nonimmunized individuals starting vaccination or HBsAg-positive individuals receiving medical evaluation). The secondary outcomes were percentage receiving HBV-test results and performance of HBV rapid tests. RESULTS: In total, 995 individuals were screened. Among the HBV-infection groups included in the primary endpoint (n=409), 20 (4.9%) received appropriate linkage-to-care, with no difference between S and R+S groups (5.7 vs. 4.1%, P=0.5). Two of eight HBsAg-positive participants had a medical visit (1/6 and 1/2 in the S and R+S groups, respectively) and 18/401 (4.5%) nonimmunized participants initiated HBV-vaccination (11/205 and 7/196). Factors that tended to be associated with linkage-to-care were female sex, birth country of high HBV prevalence, and extended medical stay. Test results were not obtained in 4.7% of participants, which was significantly higher in the S arm (P=0.02). Both sensitivity and specificity were 100% for the VIKIA-HBsAg rapid test and 94.4 and 80.8%, respectively, for the anti-HBsAb Quick Profile rapid test. CONCLUSION: Despite a higher proportion of participants obtaining their results in the R+S arm and better performance of anti-HBsAb rapid tests than described previously, we found no evidence that HBV screening based initially on rapid tests leads to increased HBV-vaccination rates or medical evaluation. This strategy should be evaluated in more hard-to-reach populations.

Current state of and needs for hepatitis B screening: results of a large screening study in a low-prevalent, metropolitan region.

BACKGROUND: In low hepatitis B virus (HBV)-prevalent countries, most HBV-infected persons are unaware of their status. We aimed to evaluate whether (i) previous HBV-testing, (ii) physicians decision to screen, and (iii) CDC's recommendations identified infected individuals and which risk-factor groups needing testing. METHODS: During a mass, multi-center HBV-screening study from September 2010-August 2011, 3929 participants were screened for hepatitis B surface antigen (HBsAg), anti-HBs and anti-Hepatitis B core antibodies (anti-HBcAb). Questions on HBV risk-factors and testing practices were asked to participants, while participants' eligibility for HBV-testing was asked to study medical professionals. RESULTS: 85 (2.2%) participants were HBsAg-positive, while 659 (16.8%) had either resolved HBV infection or isolated anti-HBcAb. When comparing practices, HBV-testing was more likely to occur in HBV-infected participants if Centers for Disease Control and Prevention (CDC) recommendations were used (Sensitivity = 100%, 95%CI: 95.8-100) than physicians' discretion (Sensitivity = 87.1%, 95%CI: 78.0-93.4) or previous HBV-test (Sensitivity = 36.5%, 95%CI: 26.3-47.6) (p<0.0001). Nevertheless, many non-infected individuals would still have been screened using CDC-recommendations (Specificity = 31.1%, 95%CI: 29.6-32.6). Using multivariable logistic regression, HBsAg-positive status was significantly associated with the following: males, originating from high HBV-endemic region, contact with HBV-infected individual, without national healthcare, and intravenous-drug user (IDU). Of these risk-factors, physician's discretion for testing HBV was not significantly associated with participants' geographical origin or IDU. CONCLUSIONS: Missed opportunities of HBV-screening are largely due to underestimating country of origin as a risk-factor. Applying CDC-recommendations could improve HBV-screening, but with the disadvantage of many tests. Further development of HBV-testing strategies is necessary, especially before severe disease occurs.

Performance of rapid tests for detection of HBsAg and anti-HBsAb in a large cohort, France.

BACKGROUND & AIMS: The systematic use of rapid tests performed at points-of-care may facilitate hepatitis B virus (HBV) screening and substantially increase HBV infection awareness. The aim of this study was to evaluate the effectiveness of such tests for HBsAg and anti-HBsAb detection among individuals visiting a variety of healthcare centers located in a low HBV-prevalent area. METHODS: Three rapid tests for hepatitis B surface antigen (HBsAg) detection (VIKIA, Determine and Quick Profile) and one test for anti-hepatitis B surface antibody (anti-HBsAb) detection (Quick Profile) were evaluated in comparison to ELISA serology. Sensitivity (Se), specificity (Sp), positive and negative predictive values (PPV and NPV, respectively) and area under the ROC curve were used to estimate test performance. Non-inferiority criteria of the joint Se, Sp were set at 0.80, 0.95. RESULTS: Among the 3956 subjects screened, 85 (2.1%) were HBsAg-positive and 2225 (56.5%) had a protective anti-HBsAb titer. Test Se and Sp (lower bound of 97.5% CI) were as follows: 96.5% (89.0%), 99.9% (99.8%) for Vikia; 93.6% (80.7%), 100.0% (99.8%) for Determine; and 90.5% (80.8%), 99.7% (99.5%) for Quick Profile; with all three tests achieving minimal non-inferiority criteria. False negatives were typically observed in inactive HBsAg carriers. The anti-HBsAb Quick Profile test had excellent specificity (97.8%) and PPV (97.8%) albeit low sensitivity (58.3%), thus failing to establish non-inferiority. CONCLUSIONS: All three HBsAg rapid tests could be considered ideal for HBV screening in low HBV-prevalent countries, given the ease of use, rapidity, and high classification probabilities. The anti-HBsAb Quick Profile could be considered reliable only for positive tests.

Short sleep duration and increased risk of hypertension: a primary care medicine investigation.

OBJECTIVES: Compelling evidence from laboratory-based and population-based studies link sleep loss to negative cardiovascular health outcomes. However, little is known about the association between sleep duration and hypertension in primary care health settings, independently of other well controlled clinical and biochemical characteristics. We investigated the association between sleep duration and the prevalence of hypertension adjusting for 21 potential confounding factors in a noncontrolled primary care sample. METHODS: The sample included 1046 French adults older than 40 years (mean age, 55.5 years), who visited any of the general practitioners of primary care centers in the Paris area. Blood pressure (BP) readings, blood samples and standardized health and sleep questionnaires were performed on each participant. Hypertension inclusion criteria were either high BP measurements (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg) or the use of antihypertensive medications. Sleep duration was recorded as the self-reported average number of hours of sleep per night during the week. Logistic regressions were performed to test the association between hypertension and sleep duration adjusted for sociodemographic, clinical, biochemical, lifestyle, psychological and sleep disorder covariates. RESULTS: Compared to the group sleeping 7 h, individuals sleeping 5 h or less had an increased odds ratio (OR) for the prevalence of hypertension [OR = 1.80, 95% confidence interval (1.06-3.05)], after adjusting for 21 potential confounders which did not markedly attenuate this association. CONCLUSION: Our data provide further epidemiologic evidence that with no specific selection in primary care medicine, usual short-sleep duration increases the risk of hypertension prevalence in adults over 40 years.

Post-retirement surveillance of workers exposed to asbestos or wood dust: first results of the French national SPIRALE Program.

OBJECTIVES: In France, 15 000-20 000 cancers attributable to occupational exposure occur each year. These cancers appear most often after the worker has retired. Since 1995, a system of post-retirement medical surveillance (PRMS) has been set up for former workers, but it remains largely underused. DESIGN: The SPIRALE program is a public health intervention aimed at identifying the former workers having been exposed to asbestos or wood dust during their working life and to propose them a PRMS. Additionally, it is also an epidemiologic research on the longterm effects of occupational exposure.We report the results of first years of the program conducted in 2006-2008, in 13 districts. SETTING AND PARTICIPANTS: a self-administered questionnaire was sent to 50 000 newly retired men, to identify potential past occupational carcinogen exposure. For respondents detected as possibly exposed, exposure was assessed in Health Screening Centres and a PRMS was recommended if necessary. MAIN OUTCOME MEASURES: Participation rate, rate of confirmed exposure, increased rate of PRMS, satisfaction about the program. RESULTS: The participation rate was 24%. From 12 002 questionnaires analysed, 72% of respondents were identified as possibly exposed: 3%to wood dust, 50%to asbestos and 19%to both exposures. Exposure to asbestos was confirmed for 73.4%, and according to the level of exposure, PRMS was recommended for 47.1%. Wood dust exposure was confirmed for 56.7%. In these districts, PRMS for asbestos increased by 45% and for wood dust by 600%. Additional surveys showed that participants showed a high degree of satisfaction about the program. CONCLUSIONS: The results are positive in terms of detection, information and medical surveillance of exposed workers.

Prevalence of liver fibrosis and risk factors in a general population using non-invasive biomarkers (FibroTest).

BACKGROUND: FibroTest and elastography have been validated as biomarkers of liver fibrosis in the most frequent chronic liver diseases and in the fibrosis screening of patients with diabetes. One challenge was to use them for estimating the prevalence of fibrosis, identifying independent risk factors and to propose screening strategies in the general population. METHODS: We prospectively studied 7,463 consecutive subjects aged 40 years or older. Subjects with presumed advanced fibrosis (FibroTest greater than 0.48) were re-investigated in a tertiary center. RESULTS: The sample characteristics were similar to those of the French population. FibroTest was interpretable in 99.6%. The prevalence of presumed fibrosis was 2.8%, (209/7,463), including cirrhosis in 0.3% (25/7,463); 105/209 (50%) subjects with presumed fibrosis accepted re-investigation. Fibrosis was confirmed in 50, still suspected in 27, indeterminate in 25 and not confirmed with false positive FibroTest or false negative elastography in 3 subjects. False negative rate of FibroTest estimated using elastography was 0.4% (3/766). The attributable causes for confirmed fibrosis were both alcoholic and nonalcoholic fatty liver disease (NAFLD) in 66%, NAFLD in 13%, alcohol in 9%, HCV in 6%, and other in 6%. Factors independently associated (all P < 0.003) with confirmed fibrosis were age, male gender, waist circumference, HCV antibody and alcohol consumption estimated using carbohydrate-deficient transferrin, enabling efficient screening-oriented strategies to be compared and proposed. CONCLUSIONS: Biomarkers have permitted to estimate prevalence of advanced fibrosis around 2.8% in a general population aged 40 years or older, and several risk factors which may be used for the validation of selective or non-selective screening strategies.