The SYSTAAQ Fast nCoV Direct RT-PCR kit, for in vitro diagnostic use, is intended for direct detection of N gene and RdRp gene in the ORF1ab region of the 2019-Noval Coronavirus in human respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) and Saliva without performing extraction.
• No Extraction required – direct detection from VTM or sliva.
• Multigene detection – N gene and ORF1ab detection in separate Channels. Single tube multiplex reaction – detecting N gene and ORF1ab and Internal Control in one tube.
• Highly Specific – primers and probe show 100% homology against over 57,000 COVID-19 sequences from world over currently available on NCBI and GISAID.
• No cross reaction with common human respiratory CoV or MERS.
• Liquid Ready to Use reagents, no reagent preparation (eliminating risks of contamination).
• Complete Kit: Including all components such as Master Mix, Primers, Probes, Positive control, Negative Control.
• Internal Control: Provided in separate vial with option to add during the extraction to check for possible PCR inhibition.
• Sample Volume – Requires only 7 μL of purified RNA sample.
• UDG Enzyme and dUTP in the Master Mix to prevent the reamplification of carryover PCR products between reactions.
• Sensitivity for N gene and ORF1ab – 100 Copies/ml.
• IVD, CE-Marked.