An integrated, automated system, The EasyNAT2.0 platform, consists of an instrument and a disposable cartridge.
Assay to result time is 80 minutes, including sample lysis, RNA extraction, target amplification and real time fluorescent detection.
All performed in a closed cartridge, automatically.
All reagents, including enzymes, are pre-loaded.
The user need only add samples.
After the addition of samples, the entire process will be performed automatically in a closed cartridge, therefore reduces the operator’s risk of infection, and the risk of false positive caused by aerosol cross-contamination. The reagents are glassified (dehydrated), and can be transported at ambient temperatures. The operation is very simple. The operator can use this system with 30 minutes of training. It is a low throughput machine: 2 samples at one time, can deal with around 10 patients a day per instrument.
Affordable: The consumable and the machine costs are just fractions of comparable products
Sensitive: Around 95% compared with clinical diagnosis
Specificity: Nearly 100% in the clinical studies and Lab analysis
User Friendly: Manual operation is very simple, requires about 30 minute training
Rapid: The entire process is approximately 80 minutes, including sample lysis, RNA extraction, amplification & Detection
Equipment-free: there are instruments to reduce manual operations. But they are small and low costs.
Deliverable: No cold train needed. The glassified reagents (including enzymes) can be transported at any ambient temperature.
In addition, the system is safe to use: all assay procedures occurs in a closed cartridge. No aerosol is generated or leaked during the operation, therefor greatly reduces the operator's risk of infection, and prevent false positive by cross contamination.
Our COVID-19 nucleic acid tests have obtained regulatory approvals from the Chinese FDA (registration number: 国械注准 20203400241) and Singapore government(Authorization number: MDPA2020-10).
The US FDA EUA application is accepted (EUA #: PEUA200021) and WHO EUL application is under review process (ref: a0B1r00001DfEDt).