Comparative in silico design and validation of GPS™ CoVID-19 dtec-RT-qPCR test
| Autor: | Gema Bru, Patricia Ros-Tárraga, Adrián García-Sirera, Aaron Navarro, Antonio J. Martínez-Murcia, Laura Perez |
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| Rok vydání: | 2021 |
| Předmět: |
2019-20 coronavirus outbreak
Coronavirus disease 2019 (COVID-19) diagnosis Computer science polymerase chain reaction Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Real-Time Polymerase Chain Reaction computer.software_genre Sensitivity and Specificity Applied Microbiology and Biotechnology SARS‐CoV‐2 03 medical and health sciences False positive paradox Humans Computer Simulation quality control Pandemics 030304 developmental biology 0303 health sciences SARS-CoV-2 030306 microbiology business.industry COVID-19 Reproducibility of Results Original Articles General Medicine CoVID‐19 Test (assessment) COVID-19 Nucleic Acid Testing Global Positioning System Original Article Data mining business Sequence Alignment computer Biotechnology |
| Zdroj: | Journal of Applied Microbiology |
| ISSN: | 1365-2672 1364-5072 |
| Popis: | Aims Providing a ready-to-use reverse transcriptase qPCR (RT-qPCR) method fully validated to detect the SARS-CoV-2 with a higher exclusivity than this shown by early published RT-qPCR designs. Methods and Results The specificity of the GPS™ CoVID-19 dtec-RT-qPCR test by analysis of sequence alignments was approached and compared with other RT-qPCR designs. The GPS™ CoVID-19 dtec-RT-qPCR test was validated following criteria of UNE/EN ISO 17025:2005 and ISO/IEC 15189:2012. Diagnostic validation was achieved by two independent reference laboratories, the Instituto de Salud Carlos III, (Madrid, Spain), the Public Health England (Colindale, London, UK), and received the label CE-IVD. The GPS design showed the highest exclusivity and passed all parameters of validation with strict acceptance criteria. Results from reference laboratories 100% correlated with these obtained by using reference methods and showed 100% of diagnostic sensitivity and specificity. Conclusions The CE-IVD GPS™ CoVID-19 dtec-RT-qPCR test, available worldwide with full analytical and diagnostic validation, is the more exclusive for SARS-CoV-2 by far. Significance and Impact of the Study Considering the CoVID-19 pandemic status, the exclusivity of RT-qPCR tests is crucial to avoid false positives due to related coronaviruses. This work provides of a highly specific and validated RT-qPCR method for detection of SARS-CoV-2, which represents a case of efficient transfer of technology successfully used since the pandemic was declared. |
| Databáze: | OpenAIRE |
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