Diagnostic performance of the Qiaprep amp Viral RNA UM kit for the detection of COVID-19 compared to RT-PCR

• Published in: Frontiers in medicine 2022-10, Vol.9, p.976090-976090
• Main Authors: 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
• Format: Article
• Language: English
• Subjects: amplification; cycle threshold (Ct) value; Medicine; PCR real time (qPCR); Qiaprep; SARS–CoV−2
• ISSN: 2296-858X; 2296-858X
• DOI: 10.3389/fmed.2022.976090

BackgroundRT-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. MethodsA 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. Results190 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). ConclusionThe 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.