qualyfast®SARS-CoV-2 Multiplex 2 products are rapid, sensitive, specific, reproducible and ready to use kits for detection of SARS-CoV-2 (COVID-19 virus) from biological fluids and swabs. They develop reliable and accurate diagnostic assays, essential for healthcare systems.
- Permits a simultaneous and specific detection of three targets: Gene S, gene E and gene RdRP of SARS-CoV-2
- Highlights a possible effect of inhibition in the RNA from the sample thanks to the included RNA Inhibition Amplification Control
RNA detection is done by One Step Real-Time PCR using dye labelled probes, where the reverse transcription and the subsequent amplification of specific target sequence occur in the same reaction well. The kits allow a sensitive and specific One-Step RT qPCR-based multiplex assay.
qualyfast®SARS-CoV-2 Multiplex 2 product is:
- Pre-dosed and lyophilised in the reaction tubes
- Individually packed in strips of eight
- Stable for shipment and storage at room temperature
- WHO guidelines complaint - compatible with leading open system Real-Time qPCR instruments
- Compatible with manual and automated RNA extraction systems
The kits are validated on CFX96 (Biorad) and Quant Studio (Thermo Fisher), they are also able to safely detect RNA using all common Real-Time PCR devices.
The clinical performance of qualyfast®SARS-CoV-2 Multiplex and Multiplex 2 products were tested using more than 100 respiratory specimens (nasopharyngeal swabs and biological fluids) from patients. These results were compared with those obtained with the molecular detection method of the protocol '2019-nCoV by real-time RT-PCR' suggested by Charité (Berlin), with modifications). Sensitivity, specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) for qualyfast®SARS-CoV-2 Multiplex detection kit compared with Charité protocol are >99,9%.
Results show high sensitivity and specificity to detect SARS-CoV-2. Detection limit IS ≥10 RNA copies per reaction. The specificity of the SARS-CoV-2 assay was confirmed by testing a panel consisting of different microorganisms representing the most common respiratory pathogens. No cross-reactivity was detected between any of the microorganisms tested.
Certifications: qualyfast®SARS-CoV-2 Multiplex 2 products are for In Vitro Diagnostic Use (CE IVD Mark).
Delivery information: Each kit is provided as 12 individually packed strips of 8 tubes; DNA free solution tube for rehydratation; one additional strip of 8 reaction tubes of positive controls ready to use.