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The great advantage of the test developed by Białystok scientists is both its simplicity of execution with very high sensitivity (95-100%) and specificity (93-100%) as well as the possibility of using it not only in laboratory, but also in portable points, including places of patient diagnosis, places of increased epidemic control (airports, border crossings, exhibition centres, conference centres, etc.).

It is developed by a team of scientists and experts from the Academic Centre for Pathomorphological and Genetic-Molecular Diagnostics (AODPGM) and the Medical University of Bialystok (MUB).

New hybrid molecular test, codenamed (SARS-HYB-45), could revolutionise the medical diagnostics market due to its lower cost, greater accuracy, shorter time and simpler execution procedure than the currently used genetic PCR tests (it takes 45 minutes between the collection of material and the test result). The test will be offered as a ready-to-use product - made from ready reaction vessels loaded with reaction mixtures, which only require biological material to be provided and the reaction will be inserted into much cheaper and more accessible equipment. The test should be widely available by mid 2022.

For this purpose, scientists from MUB have just received over 3.3 million PLN funding from the National Centre for Research and Development (NCBiR). AODOGM/MUB submitted a grant application entitled: "Development and clinical validation of a new hybrid molecular test (SARS-HYB45) for direct and fast diagnosis of SARS-CoV-2: laboratory application and "point-of-care", under the NCBR program – "Competition Fast Track – Coronaviruses". Academic Centre in cooperation with MUB received a very high score and took the second place in the list of projects recommended for funding in the category "Projects located in a region other than Mazovia".

Diagnostic test SARS-Hyb-45 is developed in two versions: Laboratory version for high-throughput application in a stationary laboratory, allowing the analysis of hundreds of samples in less than 45 minutes. and "Point of Care" for application in the form of a fast, personalised and easy to perform test ("bedside analysis" at the point-of-care, POC) – analysis of single or dozens of samples in a time not exceeding 45 min.

Both applications will be developed in the "+MOBILITY" variant for use as a quick and easy test in a mini-mobile laboratory (laboratory in a bus) or a mini-portable laboratory in a dedicated location. This will create the possibility of testing for SARS-CoV-2 in places of increased epidemic control (airports, border crossings, exhibition centres, etc.)

The action of the molecular diagnostic test SARS-Hyb-45 is based on the platform of two integrated technologies of isothermal amplification of genetic material, interacting in the RIDA system, developed by MUB scientists and covered by intellectual property protection.

The uniqueness, flexibility and innovation of the original RIDA (Rapid Isothermal Dual Amplification) technology, which is the core of the SARS-Hyb-45 test, makes it possible to adapt the platform very quickly for new genetic tests, including emerging human pathogens.

The commercialisation Plan assumes gaining a significant position in the market due to the combination of the following features of the test:

• high speed of execution
• high sensitivity and specificity
• low cost
• versatility of the solution

Scientists from the Academic Centre for Pathomorphological and Genetic-Molecular Diagnostics and the Medical University of Bialystok began conceptual work on a quick test shortly after the onset of the pandemic in Poland in March 2020, and thanks to the vast experience gained during the diagnostic tests in the Podlaskie region during the pandemic (up to now, about 100 000 tests have been performed).