FLUXERGY Test Kit COVID-19
- RUO - CE IVD
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The Fluxergy Test Kit COVID-19, which utilizes state-of-the-art Sample-to-Answer-RT-PCR and microfluidics technology, has been shown to identify the SARS-CoV-2 virus in one hour. This device is solely intended to be used by healthcare professionals. Results were obtained from internal performance evaluation using clinical samples benchmarked against an FDA-EUA approved method.
• Simple Workflow designed for rapid testing
• Minimal hands-on time per sample
• Real-Time RT-PCR, RNA extraction NOT required.
• Assay Target: SARS-CoV-2 N-gene and orf1 ab gene
• Limit of Detection (LOD): 0.89 TCID50/mL of sample
• Sample: NP swab in VTM.
Fluxergy has obtained CE marking for its one-hour COVID-19RT-PCR test, to use by healthcare professionals as an in vitro diagnostics (IVD) for the detection of SARS-CoV-2. The CE-mark will allow Fluxergy’s innovative testing platform to enter the European Union market and any other markets that accept CE-marking 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 medical device industry’s most widely used international standard for quality management systems to design, develop, produce, and deliver products. MDSAP certification satisfies the quality system requirements of the regulatory authorities participating in the program, including the U.S. Food and Drug Administration (FDA), Health Canada, Brazil’s Agência Nacional de Vigilância Sanitária and Australia’s Therapeutic Goods Administration.
In addition to exploring saliva/throat/nasal swab sample types for our existing COVID-19 test, we are also developing tests that can utilize Fluxergy’s first-of-its-kind multimodal technology. We are designing the following tests for the existing Fluxergy Analyzer model. Our product development pipeline includes:
• COVID-1 9 IgG Antibody Test
• Combined Test for SARS-CoV-2 RNA + COVID-19IgG (a first in multimodal testing)
• Respiratory COVID-1 9/Influenza/RSV PCR panel