Author Archives: beawire

THE IMPACT OF POTENTIALLY INTERFERING SUBSTANCES ON THE RESULTS OF CLINICAL LABORATORY TESTS

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

Read more

About trials on the spot

Note: This article does not apply to in vitro testing of medical devices for diagnostics, as in this case field trials (trials on the spot or so called factory audit for testing) are not applicable. Introduction Tests conducted for the purposes of the state registration of medical devices are regulated by Order No. 2n dated 09 January 2014 “On Approval

Read more

Lasers used in cosmetology

The invention of the laser became one of the most important and significant achievements of the twentieth century. Currently laser technologies are used in almost all spheres of life: science, armaments, industry, etc. Lasers are also widely used in medicine, one of the areas of which is cosmetology. A laser is a device that converts pumping energy (light, electrical, thermal,

Read more

Omics technologies

According to the Deputy Head of the Research Institute of Clinical and Experimental Lymphology for scientific work, Doctor of Medical Sciences Vadim Klimontov: “Omixes” are technologies which are based on the achievements of genomics, transcriptomics, proteomics, metabolomics, that means, sciences that study how the genome is arranged and how the information, which is encoded in it, implemented. How it is

Read more

Lost of accreditation.Who is next?

Technical testing and toxicological testing of medical devices should be carried out in a testing laboratory with the appropriate scope of accreditation. Information on the accreditation of the laboratory can be found in the general access on the website of the Federal Service for Accreditation (RusAccreditation). How to check the scope of laboratory accreditation: Visit the RusAccreditation website in the

Read more

 Testing of a medical device for the purposes of marketing authorisation, particularly on-site visits as one of the testing methods

 Testing of a medical device for the purposes of marketing authorisation, particularly on-site visits as one of the testing methods. Marketing authorisation of medical devices consists of several steps, one of which is testing. Testing could be of three types, namely: Toxicology testing, Technical testing, and Clinical testing (trials) The procedure for the testing mentioned above is set forth in

Read more

Skin aging and UV radiation

For many people, it sounds strange, but the skin is the biggest organ of our body, which is exposed to the strongest environmental impact every day. During life, the skin accumulates various lesions and therefore is a visual “aid” for aging of the human body. Skin aging at this stage of evolutionary development is an inevitable process, but someone manages

Read more

In vitro diagnosis of autoimmune diseases

Autoimmune diseases (AID) develop in cases where antibodies (AT) or T cell clones are present in the body, directed against the body’s own antigens (AG). Autoimmune mechanisms are at the heart of many organo-specific and systemic diseases.  These diseases include rheumatoid arthritis, insulin-dependent diabetes mellitus, ulcerative colitis and other less known diseases. The resulting autoimmune process is usually chronic and

Read more

Orphan diseases

According to the All-Russian Society of Orphan Diseases, about 30 million patients with rare diseases were registered in the European Union. This means that every 15th European suffers from one or another orphan disease. The figures are impressive, given that the synonym for orphan diseases is “rare diseases”. Federal Law 323 states that orphan disease is a disease the prevalence

Read more
« Older Entries