Description
Using state-of-the-art sample-to-response RT-PCR and microfluidic technology, the Fluxergy Test Kit COVID-19 has been shown to identify the SARS-CoV-2 virus within one hour. This device is exclusively intended for use by healthcare professionals. Results were obtained from internal performance evaluation using clinical samples compared to a US-FDA approved method.
• Simple workflow designed for quick tests
• Minimum handling time per sample
• Real-time RT-PCR, NO RNA extraction is required.
• Assay target: SARS-CoV-2 N gene and orf1 ab gene
• Limit of Detection (LOD): 0.89 TCID50 / mL sample
• Sample: NP swab in VTM.
Fluency has obtained the CE marking 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 meets 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 Therapeutic Goods Agency 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 RNA + COVID-19IgG (a first in multimodal testing)
- COVID-1 9 / Influenza / RSV respiratory PCR panel