This new molecular kit has been developed for the clinical diagnosis of COVID-19. RNA extracted from patient samples can then be analysed using the genesig Coronavirus (COVID-19) CE IVD test. The detection profile of the kit displays zero cross reactivity with other related viruses and 100% homology with all published SARS-CoV-2 sequences.
- Validated against CFX (Bio-Rad), ABI 7500 (Applied Biosystems) and LC480 (Roche)
- Reaction size is 96
- Master mix included
- Kit targets the RdRp gene (RNA dependant RNA polymerase), and has 100% homology with all publicly available sequences
- Traceability of values assigned to calibrating of control materials. Assured through reference measurement procedures
- Comprehensive validation in concordance with ISO13485. Post-market maintenance of technical files, including strain information
- Total kit performance measurement and assurance provided
- Lyophilised kits with no dry ice shipping requirement
Rigorous validation performed; multiple studies include:
- Analytical sensitivity – Analysis of limit of detection.
- Analytical specificity – Detection profile is specific to COVID-19. Performed bioinformatically (in silico) and in the laboratory (in vitro) against other organisms to ensure no cross reactivity.
- Reproducibility – 95% confidence interval within results to ensure data is consistent.
- Repeatability – Intra and inter run variation confidence. Repeatability across different instrument manufacturers. Repeatability between users.
The kit includes an Internal Control to identify possible PCR inhibition, to measure extraction purity and to confirm the integrity of PCR run. The CE kits come combined with Oasig™ Lyophillised Master Mix providing a complete one kit diagnostic system.
Lieferumfang: Kit components: oasig® Lyophilized qPCR OneStep Master Mix, COVID-19 Primer & Probe Mix, Master Mix Resuspension buffer, Kit Resuspension buffer, Water RNase/DNase Free, COVID-19 Positive control template and RNA Internal extraction control.
