Standard detection methods for viral RNA in patients include RNA purification, reverse transcription and quantitative PCR (RT-qPCR). These processes are time consuming, require multiple biochemical reagents, lab-grade instruments and trained professionals. Further, most qRT-PCR assays are inherently complex and require a time-consuming multi-step RNA extraction prior to nucleic acid amplification and achieve desired detection performance. Such assays also require real-time fluorescence detection equipment that is typically limited to 96 samples per instrument run.
The AirJump sample preparation will be used for extraction of SAR-Cov2-RNA. The AirJump performs efficiently, with high analyte yield, high purity, no cross contamination, rapid time-to-isolation, and excellent reproducibility.
This study aims to establish a proof of concept and carry out validation of RARA assay in the laboratory before the field evaluation in testing of SARS-CoV-2. The inherent characteristics of this assay will be evaluated with regard to accuracy (diagnostic sensitivity, diagnostic specificity), Precision (reproducibility), Limit of detection (LOD), Predictive value (negative and positive), and Assay Efficiency, if this validation is successful.
Expected impact: An fordable, accurate, highly sensitive point-of-care test for SARS-Cov2 virus.
