NEW YORK — Rendu Biotechnology said on Monday that it has received emergency approval from China's National Medical Products Administration for a SARS-Cov-2 nucleic acid detection kit.
According to Shanghai-based Rendu, the kit uses RNA-specific target capture and real-time transcription-mediated, constant-temperature amplification detection technology. Nucleic acid extraction and amplification steps are performed in a single reaction tube, with results available within 90 minutes. The sensitivity and specificity of detection results can reach the level of traditional PCR methods, the company added.
Rendu said that it has also launched AutoSAT — an automated high-throughput platform that performs nucleic acid extraction, amplification reactions, and results reporting — for use with the SARS-CoV-2 kit. The instrument can complete 200 tests in 8 hours and 700 tests in 24 hours, the firm said.