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Comparison and Harmonization of Different Semi-Automated and Automated qRT-PCR Assays in the Assessment of SARS-CoV-2.
Dierks, Sascha; Thiele, Karin; Bohne, Wolfgang; Lugert, Raimond; Weig, Michael; Groß, Uwe; von Ahsen, Nicolas; Schanz, Julie; Fischer, Andreas; Schnelle, Moritz.
  • Dierks S; Department of Clinical Chemistry, University Medical Center Göttingen, 37075 Göttingen, Germany.
  • Thiele K; Interdisciplinary UMG Laboratory, University Medical Center Göttingen, 37075 Göttingen, Germany.
  • Bohne W; Department of Clinical Chemistry, University Medical Center Göttingen, 37075 Göttingen, Germany.
  • Lugert R; Interdisciplinary UMG Laboratory, University Medical Center Göttingen, 37075 Göttingen, Germany.
  • Weig M; Interdisciplinary UMG Laboratory, University Medical Center Göttingen, 37075 Göttingen, Germany.
  • Groß U; Medical Microbiology and Virology, University Medical Center Göttingen, 37075 Göttingen, Germany.
  • von Ahsen N; Interdisciplinary UMG Laboratory, University Medical Center Göttingen, 37075 Göttingen, Germany.
  • Schanz J; Medical Microbiology and Virology, University Medical Center Göttingen, 37075 Göttingen, Germany.
  • Fischer A; Interdisciplinary UMG Laboratory, University Medical Center Göttingen, 37075 Göttingen, Germany.
  • Schnelle M; Medical Microbiology and Virology, University Medical Center Göttingen, 37075 Göttingen, Germany.
Viruses ; 14(10)2022 10 12.
Article in English | MEDLINE | ID: covidwho-2071834
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Scrapie / COVID-19 Type of study: Diagnostic study / Qualitative research Topics: Long Covid Limits: Animals / Humans Language: English Year: 2022 Document Type: Article Affiliation country: V14102239

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Scrapie / COVID-19 Type of study: Diagnostic study / Qualitative research Topics: Long Covid Limits: Animals / Humans Language: English Year: 2022 Document Type: Article Affiliation country: V14102239