Test type: T-PCR, direct

Time to result: ~ 60 minutes

Sample preparation: ~ 3 min from reagent thaw, no extraction required

Sample Type: NPS in 3 mL VTM, see accepted VTM *

Sample volume required: 14 µL

Storage Condition: Fluxergy COVID-19 Card: 10 ° to 30 ° C Fluxergy COVID-19 Reaction Mix: -10 ° to -30 ° C

Genes targets: Orf1ab polyprotein and N gene; Detects B.1.351 and B.1.1.7. variants (no difference)

LOD *: 0.89 TCID50 / ml

Platform Specifications:

Analyzer Size: 26.19 cm x 13.13 cm x 25.80 cm

Analyzer Weight: 6.8 kg

Power input: 12V DC, 7A

Operating temperature: 15 ° C – 30 ° C

Storage temperature: 15 ° C – 30 ° C

Operating humidity: 10% -85%

Recommended computer requirements: Operating system: Operating system must be 64-bit, Windows 10 v1151 or later

Processor: Intel Core i5 2.5GHz or equivalent Ram: 8GB DDR4 HDD: 250GB

Display: 1080p

USB: 2×2.0 port (for scanner and mouse)

Networks: Ethernet port

Data analysis tools: qualitative interpretation of results

Fluxergy has obtained the CE mark for its one-hour Fluxergy  COVID-19RT-PCR test Kit 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