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Background and Aims: Screening strategies for undiagnosed infections are fundamental for hepatitis C virus (HCV) elimination. We previously investigated HCV prevalence and screening strategies in an urban primary care setting. IV drug abuse, blood transfusion before 1992, immigration, or elevated ALT were identified as risk factors in a post hoc analysis and diagnosed 83% of unknown HCV‐RNA‐positive cases by screening only 26% of the population. We aimed to validate prospectively the proposed screening algorithm in two independent urban and rural cohorts and to analyse for potential differences. Methods: Anti‐HCV and ALT were included in a routine check‐up together with a questionnaire covering risk factors. HCV‐RNA was analysed in anti‐HCV‐positive individuals. Results: In urban and rural areas, 4323 and 9321 individuals were recruited. The anti‐HCV prevalence was 0.56% and 0.49%, and 0.1% of patients were HCV‐RNA‐positive in both regions. Fifty‐two anti‐HCV positive patients including eight HCV‐RNA‐positive cases were unaware of the infection (number needed to screen to detect one unknown anti‐HCV‐positive individual: 262). At least one of the three aforementioned risk factors or elevated serum ALT was present in 3000 patients (22%). Restricting HCV screening to only those with risk factors, 52% and 75% of all anti‐HCV and HCV‐RNA‐positive undiagnosed patients were identified (number needed to screen: 111). Conclusions: We confirm prospectively the efficiency of a risk‐based HCV screening. The risk‐based algorithm should be evaluated in other countries with similarly low HCV prevalence as in Germany to achieve WHO HCV elimination goals. [ABSTRACT FROM AUTHOR]

The World Health Organization and the German government have announced an initiative to eliminate chronic hepatitis C until the year 2030. To reach this goal, one important step is adequate screening and detection of so far undiagnosed infections. The most common initial test is anti‐HCV. This parameter was extra‐budgetary reimbursed by statuary healthcare insurances in the past. However, this policy has changed after a nationwide laboratory reform which should reduce the laboratory costs of patients insured in the statuary healthcare insurances. We therefore analysed the impact of the laboratory reform on the order of anti‐HCV tests in 510 656 anonymized patient data sets before and after the initiation of the reform. The number of anti‐HCV tests declined by 9.4% in quarters I‐III 2018 in comparison with the same time period of the year 2017. The number of HBsAg tests declined by 7.4%, indicating that the reduced anti‐HCV laboratory orders are not parameter‐specific, but most likely a surrogate of the intention of the laboratory reform to generally lower the demands of blood samples and laboratory costs. Thus, the scenario is an important example, how political decisions of the medical self‐government influence the screening setting for viral hepatitis: if the current policy is not changed, the laboratory reform directly counteracts the WHO hepatitis C elimination strategy in Germany. [ABSTRACT FROM AUTHOR]