التفاصيل البيبلوغرافية
| العنوان: |
Clinical Evaluation of a Fully-Automated High-Throughput Multiplex Screening-Assay to Detect and Differentiate the SARS-CoV-2 B.1.1.529 (Omicron) and B.1.617.2 (Delta) Lineage Variants. |
| المؤلفون: |
Nörz, Dominik, Grunwald, Moritz, Tang, Hui Ting, Weinschenk, Celine, Günther, Thomas, Robitaille, Alexis, Giersch, Katja, Fischer, Nicole, Grundhoff, Adam, Aepfelbacher, Martin, Pfefferle, Susanne, Lütgehetmann, Marc |
| المصدر: |
Viruses (1999-4915); Mar2022, Vol. 14 Issue 3, p608-608, 10p |
| مصطلحات موضوعية: |
SARS-CoV-2 Omicron variant, SARS-CoV-2 Delta variant, SARS-CoV-2, MONOCLONAL antibodies, EXOMES, WHOLE genome sequencing, HUMAN DNA |
| مستخلص: |
Background: The recently emerged SARS-CoV-2 B.1.1.529 lineage and its sublineages (Omicron variant) pose a new challenge to healthcare systems worldwide due to its ability to efficiently spread in immunized populations and its resistance to currently available monoclonal antibody therapies. RT-PCR-based variant tests can be used to screen large sample-sets rapidly and accurately for relevant variants of concern (VOC). The aim of this study was to establish and validate a multiplex assay on the cobas 6800/8800 systems to allow discrimination between the two currently circulating VOCs, Omicron and Delta, in clinical samples. Methods: Primers and probes were evaluated for multiplex compatibility. Analytic performance was assessed using cell culture supernatant of an Omicron variant isolate and a clinical Delta variant sample, normalized to WHO-Standard. Clinical performance of the multiplex assay was benchmarked against NGS results. Results: In silico testing of all oligos showed no interactions with a high risk of primer-dimer formation or amplification of human DNA/RNA. Over 99.9% of all currently available Omicron variant sequences are a perfect match for at least one of the three Omicron targets included in the multiplex. Analytic sensitivity was determined as 19.0 IU/mL (CI95%: 12.9–132.2 IU/mL) for the A67V + del-HV69-70 target, 193.9 IU/mL (CI95%: 144.7–334.7 IU/mL) for the E484A target, 35.5 IU/mL (CI95%: 23.3–158.0 IU/mL) for the N679K + P681H target and 105.0 IU/mL (CI95%: 80.7–129.3 IU/mL) for the P681R target. All sequence variances were correctly detected in the clinical sample set (225/225 Targets). Conclusion: RT-PCR-based variant screening compared to whole genome sequencing is both rapid and reliable in detecting relevant sequence variations in SARS-CoV-2 positive samples to exclude or verify relevant VOCs. This allows short-term decision-making, e.g., for patient treatment or public health measures. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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