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Fischer, Andreas
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Fischer, Andreas
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Fischer, Andreas
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Fischer, A.
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2022Journal Article [["dc.bibliographiccitation.firstpage","2239"],["dc.bibliographiccitation.issue","10"],["dc.bibliographiccitation.journal","Viruses"],["dc.bibliographiccitation.volume","14"],["dc.contributor.affiliation","Dierks, Sascha; 1Department of Clinical Chemistry, University Medical Center Göttingen, 37075 Göttingen, Germany"],["dc.contributor.affiliation","Thiele, Karin; 1Department of Clinical Chemistry, University Medical Center Göttingen, 37075 Göttingen, Germany"],["dc.contributor.affiliation","Bohne, Wolfgang; 2Interdisciplinary UMG Laboratory, University Medical Center Göttingen, 37075 Göttingen, Germany"],["dc.contributor.affiliation","Lugert, Raimond; 2Interdisciplinary UMG Laboratory, University Medical Center Göttingen, 37075 Göttingen, Germany"],["dc.contributor.affiliation","Weig, Michael; 2Interdisciplinary UMG Laboratory, University Medical Center Göttingen, 37075 Göttingen, Germany"],["dc.contributor.affiliation","Groß, Uwe; 2Interdisciplinary UMG Laboratory, University Medical Center Göttingen, 37075 Göttingen, Germany"],["dc.contributor.affiliation","von Ahsen, Nicolas; 1Department of Clinical Chemistry, University Medical Center Göttingen, 37075 Göttingen, Germany"],["dc.contributor.affiliation","Schanz, Julie; 1Department of Clinical Chemistry, University Medical Center Göttingen, 37075 Göttingen, Germany"],["dc.contributor.affiliation","Fischer, Andreas; 1Department of Clinical Chemistry, University Medical Center Göttingen, 37075 Göttingen, Germany"],["dc.contributor.affiliation","Schnelle, Moritz; 1Department of Clinical Chemistry, University Medical Center Göttingen, 37075 Göttingen, Germany"],["dc.contributor.author","Dierks, Sascha"],["dc.contributor.author","Thiele, Karin"],["dc.contributor.author","Bohne, Wolfgang"],["dc.contributor.author","Lugert, Raimond"],["dc.contributor.author","Weig, Michael"],["dc.contributor.author","Groß, Uwe"],["dc.contributor.author","von Ahsen, Nicolas"],["dc.contributor.author","Schanz, Julie"],["dc.contributor.author","Fischer, Andreas"],["dc.contributor.author","Schnelle, Moritz"],["dc.date.accessioned","2022-12-01T08:31:48Z"],["dc.date.available","2022-12-01T08:31:48Z"],["dc.date.issued","2022"],["dc.date.updated","2022-11-11T13:11:59Z"],["dc.description.abstract","In SARS-CoV-2 diagnostics, cycle threshold (Ct) values from qRT-PCRs semi-quantitatively estimate a patient’s viral load. However, relevant analytical differences between qRT-PCR assays are often neglected. This study was designed (i) to identify such differences between five commonly used assays and (ii) to demonstrate a straightforward strategy to harmonize them. QRT-PCRs for SARS-CoV-2 were carried out in 85 oropharyngeal swab samples using three fully automated (Alinity m, cobas®6800 and GeneXpert) and two semi-automated (genesig® and RIDA®GENE) assays. Qualitative results (positive/negative) showed excellent comparability between the fully automated assays, but not between the Alinity m and semi-automated methods. Ct values significantly varied between all the methods, with the median values ranging from 22.76 (Alinity m) to 30.89 (RIDA®GENE) and 31.50 (genesig®), indicating the lowest sensitivity for semi-automated methods. Passing–Bablok analysis further revealed systemic biases. Assay-specific viral load concentration calculations—based on generated individual standard curves—resulted in much better comparability between the assays. Applying these calculations, significant differences were no longer detectable. This study highlights relevant analytical differences between SARS-CoV-2 qRT-PCR assays, leading to divergent decisions about the mandatory isolation of infected individuals. Secondly, we propose a strategy to harmonize qRT-PCR assays to achieve better comparability. Our findings are of particular interest for laboratories utilizing different assays."],["dc.description.sponsorship","VolkswagenStiftung"],["dc.description.sponsorship","Open-Access-Publikationsfonds 2022"],["dc.identifier.doi","10.3390/v14102239"],["dc.identifier.pii","v14102239"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/118269"],["dc.language.iso","en"],["dc.notes.intern","DOI-Import GROB-621"],["dc.relation.eissn","1999-4915"],["dc.rights","CC BY 4.0"],["dc.title","Comparison and Harmonization of Different Semi-Automated and Automated qRT-PCR Assays in the Assessment of SARS-CoV-2"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.version","unpublished"],["dspace.entity.type","Publication"]]Details DOI2022Journal Article [["dc.bibliographiccitation.issue","0"],["dc.bibliographiccitation.journal","Clinical Chemistry and Laboratory Medicine (CCLM)"],["dc.bibliographiccitation.volume","0"],["dc.contributor.author","Dierks, Sascha"],["dc.contributor.author","Andag, Reiner"],["dc.contributor.author","Gauss, Friederike"],["dc.contributor.author","Budde, Kathrin"],["dc.contributor.author","Francke, Paul"],["dc.contributor.author","Peschka, Manuela"],["dc.contributor.author","Fischer, Andreas"],["dc.contributor.author","Schanz, Julie"],["dc.contributor.author","Petersmann, Astrid"],["dc.date.accessioned","2022-05-02T08:09:29Z"],["dc.date.available","2022-05-02T08:09:29Z"],["dc.date.issued","2022"],["dc.description.abstract","Abstract Objectives Thyroid-stimulating hormone (TSH) is the routine primary screening test to assess thyroid function and rapid measurement of TSH levels is highly desirable especially in emergency situations. In the present study, we compared the analytical performance of a commercially available point-of-care test (AFIAS-1) and five laboratory-based systems. Methods Left over material of 60 patient plasma samples was collected from patient care and used in the respective assay. For statistical analysis of the produced data Bland-Altman and Passing-Bablok regression analysis were applied. Results Good correlation (r=0.982 or higher) was found between all devices. Slopes from regression analysis ranged from 0.972 (95% CI: 0.927–1.013) to 1.276 (95% CI: 1.210–1.315). Among the compared devices, imprecision was high in terms of coefficient of variation (CV=10.3%) for low TSH concentrations and lower (CV=7.3%) for high TSH concentrations. Independent of the method used, we demonstrated a poor standardization of TSH assays, which might impact clinical diagnosis e.g. of hyperthyreosis. Conclusions This study shows that the point-of-care (POC) test AFIAS-1 can serve as an alternative to laboratory-based assays. In addition the data imply that better standardization of TSH measurements is needed."],["dc.description.abstract","Abstract Objectives Thyroid-stimulating hormone (TSH) is the routine primary screening test to assess thyroid function and rapid measurement of TSH levels is highly desirable especially in emergency situations. In the present study, we compared the analytical performance of a commercially available point-of-care test (AFIAS-1) and five laboratory-based systems. Methods Left over material of 60 patient plasma samples was collected from patient care and used in the respective assay. For statistical analysis of the produced data Bland-Altman and Passing-Bablok regression analysis were applied. Results Good correlation (r=0.982 or higher) was found between all devices. Slopes from regression analysis ranged from 0.972 (95% CI: 0.927–1.013) to 1.276 (95% CI: 1.210–1.315). Among the compared devices, imprecision was high in terms of coefficient of variation (CV=10.3%) for low TSH concentrations and lower (CV=7.3%) for high TSH concentrations. Independent of the method used, we demonstrated a poor standardization of TSH assays, which might impact clinical diagnosis e.g. of hyperthyreosis. Conclusions This study shows that the point-of-care (POC) test AFIAS-1 can serve as an alternative to laboratory-based assays. In addition the data imply that better standardization of TSH measurements is needed."],["dc.identifier.doi","10.1515/cclm-2022-0054"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/107390"],["dc.language.iso","en"],["dc.notes.intern","DOI Import GROB-561"],["dc.relation.eissn","1437-4331"],["dc.relation.issn","1434-6621"],["dc.title","Evaluation of the AFIAS-1 thyroid-stimulating hormone point of care test and comparison with laboratory-based devices"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dspace.entity.type","Publication"]]Details DOI