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Diagnostic performance of the Qiaprep amp Viral RNA UM kit for the detection of COVID-19 compared to RT-PCR.
Becerril Vargas, Eduardo; Cojuc-Konigsberg, Gabriel; Braverman-Poyastro, Alan; Armendáriz Mendoza, Erick; Mujica Sánchez, Mario Alberto; García Colín, María Del Carmen; Chávez Morales, Hansel Hugo; Aguirre Pineda, José Nicolás; Ibarra Cobas, Luis Carlos.
Afiliação
  • Becerril Vargas E; Clinical Microbiology Laboratory, National Institute of Respiratory Diseases, Mexico City, Mexico.
  • Cojuc-Konigsberg G; Clinical Microbiology Laboratory, National Institute of Respiratory Diseases, Mexico City, Mexico.
  • Braverman-Poyastro A; Clinical Microbiology Laboratory, National Institute of Respiratory Diseases, Mexico City, Mexico.
  • Armendáriz Mendoza E; Clinical Microbiology Laboratory, National Institute of Respiratory Diseases, Mexico City, Mexico.
  • Mujica Sánchez MA; Clinical Microbiology Laboratory, National Institute of Respiratory Diseases, Mexico City, Mexico.
  • García Colín MDC; Clinical Microbiology Laboratory, National Institute of Respiratory Diseases, Mexico City, Mexico.
  • Chávez Morales HH; Clinical Microbiology Laboratory, National Institute of Respiratory Diseases, Mexico City, Mexico.
  • Aguirre Pineda JN; Clinical Microbiology Laboratory, National Institute of Respiratory Diseases, Mexico City, Mexico.
  • Ibarra Cobas LC; Clinical Microbiology Laboratory, National Institute of Respiratory Diseases, Mexico City, Mexico.
Front Med (Lausanne) ; 9: 976090, 2022.
Article em En | MEDLINE | ID: mdl-36275813
Background: RT-PCR is the currently recommended laboratory method for diagnosing acute SARS-CoV-2 infection. Nevertheless, to carry out this assay, numerous manual steps are necessary, but they are long lasting and error-prone. A new sample preparation solution was launched, the Qiaprep & amp Viral RNA UM kit, that combines a short, liquid-based sample preparation with one-step RT-PCR amplification and detection of SARS-CoV-2. Such alternative allows reducing the handling of samples and obtaining a result in a shorter period of time. The objective of the study was to compare the performance of the kit with RT-PCR. Methods: A prospective trial was carried out in the clinical microbiology laboratory of a tertiary care hospital. The pharyngeal and nasopharyngeal swabs included in the study were taken from patients who underwent medical consultation because compatible COVID-19 symptoms. Samples were processed simultaneously for the reference RT-PCR and by the QIA P&A kit. Results: 190 samples were included in the clinical trial. The reference RT-PCR method indicated that 125 (66%) samples, out of the 190, were positive. The QIA P&A kit showed 112 positive samples for SARS-CoV-2. The QIA P&A kit has a sensitivity of 86% to detect SARS-CoV-2 and a 100% specificity, the positive predictive value was of 96%, the negative predictive value 78%, and the obtained Kappa value was 0,76. QIA P&A kit showed a lower mean cycle threshold compared with the diagnostic standard, with a statistically significant difference (p < 0.05). Conclusion: The QIA P&A kit has an acceptable, yet not optimal performance for sample preparation and amplification of SARS-CoV-2 and further studying is required for it to be validated as a cost-effective, rapid diagnostic method for detecting infections.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Diagnostic_studies / Guideline Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Diagnostic_studies / Guideline Idioma: En Ano de publicação: 2022 Tipo de documento: Article