Publications by authors named "H Scheiblauer"
The main stakeholders in external quality assessment (EQA) programs are the participants, in whose interests these challenges are ultimately organised. EQA schemes in the medical field contribute to improving the quality of patient care by evaluating the analytical and diagnostic quality of laboratory and point-of-care tests (POCT) by independent third parties and, if necessary, pointing out erroneous measurement results and analytical or diagnostic improvement potential. Other benefits include the option of using EQA samples for other important laboratory procedures, such as the verification or validation of diagnostic medical devices (IVD-MDs), a contribution to the estimation of measurement uncertainty, a means of training and educating laboratory staff through educational EQA programmes or samples, or even for independent and documented monitoring of staff competence, such as on samples with unusual or even exceptional characteristics.
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- The European Union is implementing regulations for diagnostics and public health that will establish European Reference Laboratories (EURLs) to work alongside National Reference Laboratories (NRLs) by 2024 and 2025, respectively.
- NRLs, which have functioned under national laws, are encouraged to collaborate as part of a network to improve the authorization and monitoring of in vitro diagnostics (IVDs) and manage communicable disease threats.
- A study highlighted the misuse of the term "reference laboratory" in scientific literature, leading to confusion about the roles of EURLs and NRLs, but the new EU regulations aim to clarify these roles and enhance the safety and quality of IVDs and public health surveillance.
Monitoring the SARS-CoV-2 Pandemic: Prevalence of Antibodies in a Large, Repetitive Cross-Sectional Study of Blood Donors in Germany-Results from the SeBluCo Study 2020-2022.
Pathogens
April 2023
SARS-CoV-2 serosurveillance is important to adapt infection control measures and estimate the degree of underreporting. Blood donor samples can be used as a proxy for the healthy adult population. In a repeated cross-sectional study from April 2020 to April 2021, September 2021, and April/May 2022, 13 blood establishments collected 134,510 anonymised specimens from blood donors in 28 study regions across Germany.
View Article and Find Full Text PDFBackgroundThere are conflicting reports on the performance of rapid antigen detection tests (RDT) in the detection of the SARS-CoV-2 Omicron (B.1.1.
View Article and Find Full Text PDFBackground: Reliable data on the adult SARS-CoV-2 infection fatality rate in Germany are still scarce. We performed a federal state-wide cross-sectional seroprevalence study named SaarCoPS, that is representative for the adult population including elderly individuals and nursing home residents in the Saarland.
Methods: Serum was collected from 2940 adults via stationary or mobile teams during the 1 pandemic wave steady state period.