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External quality assessments for SARS-CoV-2 genome detection in Austria : A comparison of the first postpandemic round with results from the pandemic era.
Buchta, Christoph; Aberle, Stephan W; Görzer, Irene; Griesmacher, Andrea; Müller, Mathias M; Neuwirth, Erich; Puchhammer-Stöckl, Elisabeth; Weseslindtner, Lukas; Camp, Jeremy V.
Afiliación
  • Buchta C; Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests (ÖQUASTA), Hörlgasse 18/5, 1090, Vienna, Austria.
  • Aberle SW; Center for Virology, Medical University of Vienna, Kinderspitalgasse 15, 1090, Vienna, Austria.
  • Görzer I; Center for Virology, Medical University of Vienna, Kinderspitalgasse 15, 1090, Vienna, Austria.
  • Griesmacher A; Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests (ÖQUASTA), Hörlgasse 18/5, 1090, Vienna, Austria.
  • Müller MM; Central Institute for Medical and Chemical Laboratory Diagnosis, Innsbruck University Hospital, Innsbruck, Austria.
  • Neuwirth E; Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests (ÖQUASTA), Hörlgasse 18/5, 1090, Vienna, Austria.
  • Puchhammer-Stöckl E; Faculty of Computer Science, University of Vienna, Vienna, Austria.
  • Weseslindtner L; Center for Virology, Medical University of Vienna, Kinderspitalgasse 15, 1090, Vienna, Austria.
  • Camp JV; Center for Virology, Medical University of Vienna, Kinderspitalgasse 15, 1090, Vienna, Austria.
Wien Klin Wochenschr ; 136(15-16): 429-438, 2024 Aug.
Article en En | MEDLINE | ID: mdl-38653873
ABSTRACT

BACKGROUND:

External quality assessment (EQA) schemes provide objective feedback to participating laboratories about the performance of their analytical systems and information about overall regional analytical performance. The EQAs are particularly important during pandemics as they also assess the reliability of individual test results and show opportunities to improve test strategies. With the end of the COVID-19 pandemic, the testing frequency significantly decreased in Austria. Here, we analyzed whether this decrease had an effect on participation and/or performance in SARS-CoV­2 virus detection EQAs, as compared to the pandemic era. MATERIAL AND

METHODS:

Identical samples were sent to all participating laboratories, and the EQA provider evaluated the agreement of the reported results with defined targets. The EQA was operated under two schemes with identical samples and therefore we analyzed it as a single EQA round. The performance of testing was reported as true positive ratios, comparing the post-pandemic data to previous rounds. Furthermore, subgroups of participants were analyzed stratified by laboratory type (medical or nonmedical) and the test system format (fully automated or requiring manual steps).

RESULTS:

While the frequency of false negative results per sample did not change during the 3 years of the pandemic (5.7%, 95% confidence interval [CI] 3.1-8.4%), an average per sample false negative ratio of 4.3% was observed in the first post-pandemic EQA (0%, 1.8%, and 11% for the 3 positive samples included in the test panel, n = 109 test results per sample). In this first post-pandemic EQA medical laboratories (average 0.4% false negative across 3 samples, n = 90) and automated test systems (average 1.2% false negative, n = 261) had lower false negative ratios than nonmedical laboratories (22.8%, n = 19) and manual test systems (16.7%, n = 22). These lower average ratios were due to a low concentration sample, where nonmedical laboratories reported 36.8% and manual test systems 54.5% true positive results.

CONCLUSION:

Overall ratios of true positive results were below the mean of all results during the pandemic but were similar to the first round of the pandemic. A lower post-pandemic true positive ratio was associated with specific laboratory types and assay formats, particularly for samples with low concentration. The EQAs will continue to monitor the laboratory performance to ensure the same quality of epidemiological data after the pandemic, even if vigilance has decreased.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Garantía de la Calidad de Atención de Salud / Pandemias / SARS-CoV-2 / COVID-19 Límite: Humans País/Región como asunto: Europa Idioma: En Revista: Wien Klin Wochenschr Año: 2024 Tipo del documento: Article País de afiliación: Austria Pais de publicación: Austria

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Garantía de la Calidad de Atención de Salud / Pandemias / SARS-CoV-2 / COVID-19 Límite: Humans País/Región como asunto: Europa Idioma: En Revista: Wien Klin Wochenschr Año: 2024 Tipo del documento: Article País de afiliación: Austria Pais de publicación: Austria