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

Abstract

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.

Rapid inactivation and sample preparation for SARS-CoV-2 PCR-based diagnostics using TNA-Cifer Reagent E

“…Newer systems, such as GeneXpert, have been developed, requiring less extensive training, infrastructure, and equipment, making them well-suited for resource-limited settings (Oladimeji et al, 2020 ; Rakotosamimanana et al, 2020 ). There has been a surge in innovative sample preparation methods, such as, strip- or cartridge-based systems for the aforementioned PCR machines and new kits such as the QIAprep&amp Viral RNA UM kit (Becerril Vargas et al, 2022 ). Increasing safety has been a key objective, with various developments aimed at virus inactivation before testing, thereby mitigating the risk for laboratory staff and reducing the need for equipment, infrastructure, and practices (e.g., containment level 2 requirements) that maintain infection control for a virus whose predominant transmission mode is via aerosol (Geng and Wang, 2023 ).…”