Human Diagnostics

Virus Finder COVID-19 // bKTH-SCV2.02

The portable Hyris System™ can test human samples for Covid-19 quickly and easely, anywhere, at anytime.

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Environmental testing

SARS-CoV-2 Environmental // bKTE-SCV2.01

The portable Hyris System™ provides a safe and effective way to test environmental surfaces for coronavirus.

Read the PRESS RELEASE
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The SARS-CoV-2 emergency

The COVID-19 pandemic is causing a lot of problems to our lives, and improved testing is recognised as a key element to contain and mitigate adverse impacts. The nasopharyngeal swab has been the only recognized method - from both a diagnostic and a legal perspective – to offer a conclusive diagnosis. The samples collected with the swabs need to be assessed in a lab with a specific molecular analysis of the viral RNA performed on a real time-PCR instrument. Hyris products enable genetic testing of biological samples in any setting, at any time, with real time access to results. As transmission occurs either by exposure to micro droplets loaded with the virus or by contact with contaminated surfaces, Hyris has developed a diagnostic system that can test either individuals or surfaces, offering an innovative and comprehensive product range for COVID-19 test management.

HUMAN TEST

The Hyris System™ is the ideal portable platform for POINT-OF-CARE test to detect the virus presence in individuals. The Hyris System™ offers a unique combination of clinical-grade results and unparalleled speed and ease of use, having been shown in clinical trials to offer accurate, validated results even when used outside of hospitals and centralised laboratories. A great tool to monitor and contain the spread of the novel coronavirus. By using the “Virus Finder COVID-19 // bKTH-SCV2.02” HYRIS bKIT™, the specific test for the detection of COVID-19 in human specimen, the Hyris System™ provides an answer to the question “am I COVID-19 positive?” in less than two hours, with automatical interpreted results and amazing easiness of usage.

Testing scenarios

  • MAJOR REFERENCE CENTERS
    Hospitals and reference labs
  • SATELLITE TESTING LABORATORIES
    Smaller labs located around the country
  • STRATEGICAL PRODUCTIVE FIELD
    Industrial plants, buildings, products
  • ON SITE TESTING
    Doctors and medical professionals' offices, emergency room, military sites, ships and moving labs, cruise ships and many more

Approvals

The test has been recently approved as a point-of-care test in Canada for human diagnostics as an Interim Order and obtained the European CE-IVD mark. In the US, FDA EUA is under evaluation.

ENVIRONMENTAL TEST

COVID-19 disease transmission through contaminated surfaces is a serious health risk. We all heard instructions to wash our hands often, with soap or alcohol-based gels, and to not touch our own face. The point of these precautions is to prevent us from infecting ourselves with the virus, that might be present on the objects we come into contact with every day.

SARS-CoV-2 is in fact, according to a new study1, stable for several hours to days in aerosols and on surfaces. The availability of a rapid test method able to detect a dangerous virus on environmental surfaces is of extreme importance in order to undertake appropriate sanitation measures.

By using the SARS-CoV-2 Environmental // bKTE-SCV2.01 HYRIS bKIT™, The Hyris System™ can be used to monitor the presence of environmental coronavirus in offices, industries, food manufacturing operations, oil & gas plants, healthcare facilities, sport venues and many more. Environmental PCR testing is the most efficient method to make a risk assessment and implement an early warning system against viral loading in workplaces and areas open to the public.

1 N van Doremalen, et al. Aerosol and surface stability of HCoV-19 (SARS-CoV-2) compared to SARS-CoV-1. The New England Journal of Medicine. DOI: 10.1056/NEJMc2004973 (2020).

What you can do with the Hyris System™

1.

Virus presence test

Detection of the virus presence to assess the safety of environments and develop and implement safety protocols commensurate to the measured risk.

2.

Sanitation efficency test

Verification procedure to validate the sanitation strategies and protocols put in place for the removal of the virus from surfaces and environments.

3.

Monitoring

Allows to immediately identify the virus' presence in environments and to adopt safety measures to avoid the spread of the infection among individuals.

Testing scenarios

The test has been cleared for sale in Europe, USA and Canada and is already used by customers worldwide.

Available for

  • Offices

  • Manufacturing plants

  • Food preparation sites

  • Supermarkets

  • Public transportation

  • Military vehicles

  • Restaurants

  • Vending machines

  • Healthcare facilities

  • Retirement homes

  • Theaters

  • Cinemas

  • Shopping malls

  • Museums

  • Sport centers

  • Other

Testing Process

1. Sampling

Hyris provides materials and instructions for the safe collection, transport and preservation of the samples. The swabs are based on commercially available technologies developed specifically for human and environmental surfaces testing.

DIRECT AMPLIFICATION
WITHOUT
SAMPLE PREPARATION

2. Analysis

The next step is the genetic analysis of the virus, with RT-PCR methods, using:

  • HYRIS bKIT™ for the detection of SARS-CoV-2
  • RNase free cartridges
  • HYRIS bCUBE™
  • HYRIS bAPP™

Results

The Hyris System™ has an integrated automatic data elaboration AI module which allows an immediate and simple interpretation of results on the Hyris web app software, both for the human and the environmental versions of the test.
The data generated is available and remotely accessible anywhere, anytime on the cloud.

Video tutorial

Covid-19 Environmental Testing Process

The video describes the two-steps testing process for the identification of the presence/absence of SARS-CoV-2 RNA on environmental surfaces. Here you will get a general overview of the Sampling and Analysis steps with our Virus Finder System.

For more information contact us at This email address is being protected from spambots. You need JavaScript enabled to view it. or compile the form available in our Contacts section.

Discover more about
the Hyris System™
and its featured components

Hyris System™

Contact us

To discover more how Hyris can support you in the fight against Covid-19.
Use the provided form: one of Hyris representatives will contact you as soon as possible.

Contacts

DISCLAIMER

Important Use Information

The Sars-Cov-2 Environmental HYRIS bKIT™ (bKTE-SCV2.01), which is part of the Healthcare kit array, is intended to be used by professionals in commercial settings to detect the presence of SARS-CoV-2 on non-porous hard surfaces and fomites. The Environmental test is a great way to determine whether your company’s disinfection procedures are working as you and your company’s disinfection protocol intend. Follow the use and storage instructions very carefully to ensure that the results obtained are as accurate as possible. Contamination of surfaces can occur at any point after testing or surface disinfection, so it is critical to use the Hyris Virus Finder System after each disinfection procedure.

What Can Sars-Cov-2 Environmental HYRIS bKIT™ (bKTE-SCV2.01) NOT Do?

The Sars-Cov-2 Environmental HYRIS bKIT™ (bKTE-SCV2.01) is NOT intended for use as a human diagnostic. Results obtained from the Sars-Cov-2 Environmental HYRIS bKIT™ (bKTE-SCV2.01) cannot be extrapolated from one surface, substance, or location to another surface, substance, or location. The choice of specific surfaces, substances, or locations to be tested, as well as the frequency of testing, is to be determined by the user’s protocol. The Hyris System™ does not make any representations or recommendations concerning which surfaces, substances, or locations should be tested, or how often testing should be performed. The User must follow all applicable local, state/provincial, and/or national regulations regarding Covid-19 and wear appropriate protective equipment while performing the test. If a surface is found to be contaminated, you must follow your company’s disinfection protocol regarding additional disinfection.

Limitations

The HYRIS System can only detect the presence of the SARS-CoV-2 virus within its detection limit and pursuant to its specifications. As such, even if Hyris System™ does not detect the presence of SARS CoV- 2 virus, there is a chance that the virus may be present on surfaces. While the chance of COVID-19 transmission may be reduced in such instance, a negative result from the Hyris System™ does not guarantee whether a person in contact with a surface may or may not develop COVID-19, and the Hyris System™ should not be used to assess the likelihood of developing COVID-19 or for any medical or clinical decision. Please consult with a qualified medical professional if you have any questions regarding COVID-19 in humans or if a person is suspected of having or experiences any symptoms of COVID-19. The Hyris System™, including its component parts and reagents, is not intended for any medical or clinical purpose, and the results should not be used or relied upon for any medical or clinical decision and do not constitute medical advice. If user has any medical questions, please consult with a medical professional. All claims are based on current evidence on COVID-19 and its transmission through surfaces, which may change as scientists and researchers learn more about the virus. Please consult with the latest CDC and WHO guidelines and recommendations regarding the spread of COVID-19 from surface contamination as well as cleaning/disinfecting recommendations for surfaces. The Hyris System™ and its reagents are optimized for detection of the SARS-CoV-2 virus based on current sequences published by the CDC and WHO. To the extent the virus mutates or evolves, we cannot guarantee the results will remain accurate or that the Hyris System™ will continue to be effective in detecting the virus.

FAQ

In this section we list frequently asked questions that provide relevant information regarding the test. If you’d like to receive additional details do not hesitate to contact us.

Contact us
Can I use it to test people?

Yes, HYRIS bCUBE™ now is available also for human diagnostics and not only for environmental surfaces samples.

How can I order the HYRIS bKIT™?

Contact us via email or compile the form available in the contact section of our website.

Who can use the environmental test?

Everyone, the test does not require specialized personnel. Clients will receive comprehensive training to get started!

Who can use the human diagnostic test?

The test can be performed only by healthcare professionals.

Do I need additional material?

Hyris can provide all the material required to perform the test. Request a quote for more details.

Which environment can be tested?
The test is aimed to be performed in many different scenarios:
  • Industries: plants, buildings and vehicles
  • Offices and other working areas
  • Food preparation areas
  • Transportation: cruise ships, ferrys, trains, airplanes, trains, metro, military vehicles
  • Restaurants, Bars, Cafes, night clubs
  • Vending machines, gas stations
  • Supermarkets
  • Healthcare facilities
  • Retirement homes
  • Theatre and cinemas
  • Shopping malls
  • Museums
  • Sports center
How much time do I need to get the results?

Positive samples can give results in less than an hour, negative ones up to about 1.5 Hours.

How many tests can I perform simultaneously?

Each test run can process utp to 6 samples, soon to be upgraded to 16 with no hardware change.

How should we execute a sampling plan with the environmental test?

Each environment has unique features that need to be taken into consideration. Hyris can provide options and guidelines on how to plan a sampling regimen.

Which protection dispositives should I use while sampling?

Avoid direct contact with the surfaces you are sampling. Follow all applicable local, state/provincial and/or national regulations. Wear appropriate protective equipment which incudes but is not limited to protective eyewear, face shield, clothing/lab coat (and a disposable lab coat) and gloves.

What should I do with the waste material?

The System is designed to minimise accidental contamination. Ensure that the instrument waste is stored, transferred, transported and disposed of according to all local/state/provincial and/or national regulations.

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