FLUXERGY Test Kit COVID-19
Using state-of-the-art sample-to-response RT-PCR and microfluidic technology, the Fluxergy COVID-19 Test Kit has been shown to identify the SARS-CoV-2 virus within one hour. This device is intended for healthcare professionals only. The results were obtained from an internal performance evaluation using clinical samples compared with a method approved by the FDA-USA.
- Simple workflow designed for quick tests
- Minimum handling time per sample
- Real-time RT-PCR, NO RNA extraction is required.
- Test objective: SARS-CoV-2 N gene and orf1 ab gene
- Limit of Detection (LOD): 0.89 TCID50 / mL sample
- Sample: NP swab in VTM.
Fluxergy has obtained the CE mark for its one-hour COVID-19RT-PCR test for use by healthcare professionals as an in vitro diagnostic (IVD) for the detection of SARS-CoV-2. The CE mark will allow Fluxergy’s innovative test platform to enter the European Union market and any other market that accepts the CE mark as valid regulatory approval.
In December 2020, Fluxergy received dual ISO-1 3485: 201 6 and MDSAP certifications. ISO 1 3485: 201 6 is the most widely used international standard in the medical device industry for quality management systems to design, develop, produce and deliver products. The MDSAP certification satisfies the quality system requirements of the regulatory authorities participating in the program, including the United States Food and Drug Administration (FDA), Health Canada, the Agência Nacional de Vigilância Sanitária of Brazil and the Administration of Therapeutic Products of Australia.
In addition to exploring the types of saliva/throat / nasal swabs for our existing COVID-19 test, we are also developing tests that can use Fluxergy’s first multimodal technology. We are designing the following tests for the existing Fluxergy analyzer model. Our product development line includes:
- COVID-1 IgG antibody test 9
- Combined test for SARS-CoV-2 + COVID-19IgG RNA (the first in multimodal tests)
- PCR COVID-19 / Influenza / RSV respiratory panel