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10.1111/jam.14781

http://scihub22266oqcxt.onion/10.1111/jam.14781
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32652813!7405274!32652813
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suck abstract from ncbi


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pmid32652813      J+Appl+Microbiol 2021 ; 130 (1): 2-13
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  • Comparative in silico design and validation of GPS CoVID-19 dtec-RT-qPCR test #MMPMID32652813
  • Martinez-Murcia A; Bru G; Navarro A; Ros-Tarraga P; Garcia-Sirera A; Perez L
  • J Appl Microbiol 2021[Jan]; 130 (1): 2-13 PMID32652813show ga
  • 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.
  • |COVID-19 Nucleic Acid Testing/*methods/standards[MESH]
  • |COVID-19/*diagnosis[MESH]
  • |Computer Simulation[MESH]
  • |Humans[MESH]
  • |Pandemics[MESH]
  • |Real-Time Polymerase Chain Reaction[MESH]
  • |Reproducibility of Results[MESH]
  • |SARS-CoV-2/classification/genetics/*isolation & purification[MESH]
  • |Sensitivity and Specificity[MESH]


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