Currently, there are many models of automatic analyzers that differ in the method used to detect the desired substance. The main analysis methods used are: – radioimmunological (RIA); – enzyme-linked immunosorbent assay (ELISA); – Immunofluorescence; – immunochemiluminescent; – immunochromatographic; – isoserological. Let us consider in more detail immunochemiluminescent analysis. Immunochemiluminescent analysis is based on the enzyme immunoassay. The principle of

According to the Government of the Russian Federation decree dated 27 December 2012 No. 1416 “On the approval of the rules state registration of medical devices” the term “technical testing” is defined as the testing to determine whether the characteristics (properties) of the medical device meet the requirements of the regulatory, technical and operational documentation of the producer (manufacturer) and

  Order of Russian Government 430 from 03th of April 2020 was published yesterday (06th of April 2020), what is inside: list of products intended to be used in special conditions (emergency, martial law and so on). In this list – IVD test for COVID-19, thermometers, artificial ventilator apparatus; registration certificate is issued on the base on series/LOTs of medical

The reliability and accuracy of the sample results in clinical laboratory tests are influenced by many factors, such as the preanalytical factor, sampling, transportation, storage of samples, as well as the presence of interfering substances in the biomaterial samples. Interfering substances are one of the most common errors in clinical laboratory measurements. The presence of these substances in the samples