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A WHOLE LABORATORY IN ONE DEVICE

These products are currently for exhibition and demonstration purposes only and cannot be made available until they have been made compliant with Regulation (EU) 2017/746 (IVDR)

ABSOLUTELY QUICKEST CERTAINTY 

The test delivers a rapid and definitive result in 30 minutes (LAMP test) and PCR test 90 minutes (gold standard) - from sample collection to the final result - all right at your door.


Like every real-time RT-qPCR test, BionLyx delivers results with an accuracy of over 99.8 per cent. The rapid test meets the quality standards of the World Health Organisation (WHO). 

 

The patented 
All-In-One
solution for molecular diagnostics

   

Simplest, fastest, cheapest and safest way for early detection of virus infections. 


Worldwide and for everyone.


 DETECT INFECTIONS EARLY


With the PCR rapid test, an virus infection can be detected in patients in less than 90 minutes - from taking the sample to the result. Another advantage of the PCR rapid test is that it can be carried out directly at home or on site. Transport routes, which cost valuable time, are eliminated. Patients quickly receive certainty about their state of health. Infected persons can be identified and isolated immediately. With the tests currently in use, patients usually have to expect waiting times of one to two days. 

"In the fight against coronavirus, time is one of the decisive factors. A reliable, fast diagnosis directly at home or on site without detours - that is the great advantage of our solution, which for us is also an example of technology for life."

In the case of newly emerging virus types, BionLyx can be used immediately after the first available test sample. Thus, a rapid further spread of a new or even mutated virus can be counteracted immediately. 

With one BionLyx device, two independent test samples can be prepared and analysed in parallel. Maximum approx. 24 tests per day. 

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Friendly support

Take the test smear

Step 1: The sample is taken from a patient's nose and throat using a swab. Both swabs can also be taken separately. More detailed instructions on how to collect the sample can be found here.

Please note: One test sample is required per test person.

Bend the test stick and seal it

Step 2: Insert the test sticks with the swab sample into the test cannulas (elongated tube). The test sticks are then bent at the predetermined breaking point.  

The test cannula should be closed with the help of the sealing cap.

Insert the sample into the test device

 Step 3: Insert the test sample into the test channel of the BionLyx test device. BionLyx now prepares this test sample for about 2 minutes.

 After this process, the test device automatically starts the analysis of the test sample of the person to be tested.

Reading the test result

Step 4: The test result can now be accessed via BionLyx  directly or via our app  BionLyx on your mobile phone. 

The result can now be called up with the mobile phone and the BionLyx software and sent to the family doctor or another institution.

5 tests at the same time

It is also possible to have several test samples from up to 5 people analysed together in BionLyx


In this case, up to a maximum of 5 test sticks are simply added to a test sample. If this test is positive, at least one person is infected with the virus. 


The presentation of the results is based on today's standards.


FAQs

Do you have a question? We will be happy to help you.

  • What types of viruses can be detected with the BionLyx PCR Tester?

    All types of viruses can be detected with the PCR tester from BionLyx. 


    Different test cartridges are available for the respective viruses to be tested. 


    These are e.g. influenza, Ebola, SARS, MERS, sexually transmitted infections/diseases (STI, STD), etc.

  • How does the virus test work with BionLyx?

    The virus rapid test by BionLyx is one of the world's first fully automated, private tests that detects infection for example with the Corona virus (SARS-CoV-2) as well as other nine respiratory viruses.


    Private individuals need the BionLyx evaluation device and the appropriate test sample. The test sample contains biological components that detect for example the SARS-CoV-2 pathogen and other pathogens. One test sample is required per test person. 


    After a test person's sample has been filled into the test sample, it is inserted into the evaluation device and the test then runs completely automatically. Bionlyx delivers reliable results for the detection of SARS-CoV-2 and other nine respiratory viruses in less than 30 minutes (LAMP test) and 90 minutes (PCR test gold standard).

  • What is the difference to other COVID-19 tests?

    A large number of different tests for coronavirus diagnostics are now on the market in various countries. A past infection with SARS-CoV-2 can be detected by detecting antibodies to the virus. Antibody tests can be done in the laboratory, but rapid tests are already available. In order to stop chains of infection, on the other hand, an acute infection must be indicated. 


    In addition to the genetic material, the proteins of the virus can also be detected. This is done by antigen tests, which are still rarer than genetic tests. One form of antigen tests are so-called diffusion tests, which function and look like a pregnancy test.

    These tests do not actually detect relevant pathogens (viruses). For this reason, the World Health Organisation (WHO) does not recommend this type of rapid test. 


    The majority of tests detect the genetic information of the virus, its RNA. The gold standard is PCR. In addition to PCR, however, the genetic material can also be detected using other methods. One of these is the rapid test procedure RT-LAMP.


    The sensitivity of PCR is 99 per cent, that of the worst antigen tests around 80 per cent.

  • Which detection method is used in BionLyx's PCR tester?

    A so-called PCR procedure is carried out with a polymerase chain reaction. At BionLyx, this is the quantitative real-time PCR (polymerase chain reaction), as well as the LAMP test.

  • What is the LAMP test?

    The LAMP test (loop-mediated isothermal amplification) is a method that directly detects the pathogen as in the PCR test. A viral genome detection is always more accurate and sensitive than a viral protein detection as in the antigen tests. The LAMP tests were originally developed for developing countries in order to be able to offer PCR procedures for certain pathogens there with simple methods. No complex laboratory equipment is needed, but little technical effort is required. These genome-based tests are faster and it only takes about 30 minutes to get the result. In the UK, the tests have been used in medical health care for some time.


    The LAMP test has a sensitivity of 97 to 99 per cent, much higher than antigen tests. The sensitivity is comparable to that of PCR tests. 

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