"Validation and verification of techniques - ensuring assurance of the correctness of the results"

At the very beginning of the year, on the 30th of January, 2018, some changes were made to health legislation, the essence of which was the introduction of a voluntary accreditation procedure for health facilities. Of course, laboratories are an integral part of any health care institution.

By examining in detail the requirements for the laboratory that is getting ready for accreditation, we encounter the notion of validation and verification of the methods by which diagnostics are carried out.

When faced with such new concepts, and accordingly - new tasks, we are involuntarily asking ourselves the question: What did we get with changes in the legislation: new trends or new problems? After all, according to the results of international assessments over the past three years, it has been found that the system of national laboratories meets the requirements of international standards by no more than 60%.

One of the first companies "DIAMEB Trade" has started to solve the key issues of accreditation. Together with a foreign partner, CORMAY PZ S.A., we have studied in detailі the principles of validation, which include the key points:

• truthfulness (reliability), which is an approximation to the average value obtained from a series of test results and a control value;
• accuracy, which is the density of matching between independent multiple test/measurement results (concentrations/activity) in one sample;
• the possibility of determining, including the limit of the blank, the limit of detection and the limit of quantitative determination;
• linearity - the ability (within a given range) to provide reliable results that are directly proportional to the concentration (amount)/activity of the analyte in the sample;
• interference - the ability to work with a certain level of interfering substances in the sample.

As for the verification of any analytical technique, a correlation (comparison of methods) is always carried out to assess the degree of conformity.

At present, our specialists are working on the practical implementation of the validation and verification processes of standard methods in laboratories.

We are ready to cooperate, and are always happy to help our clients keep up with the innovations in laboratory diagnostics.