FDA Emergency Use Authorization
A real-time reverse transcription polymerase chain reaction (rRT-PCR)
test designed to detect RNA from SARS-CoV-2 in respiratory specimens from
patients who are suspected of COVID-19.
COVID-19 Nucleic Acid RT-PCR Detection Kit
A reagent that combines three genetic loci of the COVID-19 with fluorescent PCR and multiplex PCR.
- Rapid screening and fast reporting: 10 minutes preparation, 15 minutes to analyze in fast mode or 30 minutes in regular mode with:
- High sensitivity: 200 copies/ml
- Early detection during latent period
- Easy Setup and Specially Designed for:
- Port Health Authority,International Points of Entry, High Speed Rail Stations, Land Border Crossings, Cruise Terminals, etc.
- Provisional Quarantine Zone
- Transportable & Mobile Environments
- Communities without Full Diagnostic Laboratory access
iPonatic portable molecular workstation
- Cost effective for on-site, limited quantity diagnostic need, specially designed for locations where laboratory technician may not be available
- Applicable specimen type:
- Pharyngeal swab
- Bronchoalveolar Wash
- Approved by National Medical Products Administration (NMPA/CFDA), TFDA&US FDA (EUA)
- Easy operation & streamline workflow: No heating, tube replacement, nucleic acid extraction, and amplification detection can be achieved in a simple step.
- The pathogen is inactivated after sampling and reach a high level of biological safety.
- The housekeeping gene and internal standard are monitored throughout to ensure the accuracy of the test results.
Components Included with the Kit
- RNA one-step nucleic acid extraction free technology: A unique nucleic acid release agent, which can rapidly analyze pathogens at room temperature and inactivate pathogens to reduce bio-safety hazards. Without boiling and changing of tube, rapid extraction of sample nucleic acid can be achieved through a simple operation. It is the only product among all manufacturers of PCR Analyzers that does not require heating or cracked by boiling.
- Higher sensitivity: 200 copies/ml. while other certified products were 1000 copies/ml.
- Internal calibration and standardized whole-process monitoring: Endogenous housekeeper gene monitoring is adopted for the entire process, (including sampling, testing, and other processes), to better avoid false-negative results. There is no internal calibration in any other licensed products on the market.
- Fast reporting time: Pre-processing of 96 samples of nucleic acid was completed by the one-step method of RNA in 30 minutes, and the results were reported within 2 hours. The shortest extraction time among similar products on the global market.
- Diversified extraction and matching methods: The reagent is well-suited to match a one-step method, a magnetic bead method, or other manufacturers’ extraction methods. The instruments are designed to match withboth iPonatic molecular workstation and Natch CS systems.