The D.I. Mendeleev All-Russian Institute for Metrology (VNIIM) news

Competence and measurement capabilities of Russian scientists in quantitative assessment of the causative agent of COVID-19 viral RNA have been confirmed at the highest presently possible level of accuracy. Four Russian scientific organizations participated in a number of comparison tests under the auspices of the International Bureau of Weights and Measures (BIPM). Twenty one National Metrology Institutes and expert medical laboratories from 16 countries participated in the tests, including three institutions from Russia:

• the Smorodintsev Research Institute of Influenza (Health Ministry),
• the Pirogov Russian National Research Medical University and VNIIMS (joint project),
• the D.I. Mendeleyev Institute for Metrology (Rosstandart).

The researches had a common task: using high-precision methods to measure content of viral genome fragments, which the bulk of SARS-CoV-2 tests were aimed to detect.

The Acting Director of the Smorodintsev Research Institute of Influenza, Dr. Dmitry Lioznov, notes that the pandemy of coronavirus SARS-CoV-2 identified a critical need to develop tests for its determination and diagnosis of COVID-19, and that the reliability of resting, taking into account its specificity and sensitivity, is a key for their practical clinical use. He states, that the joint study is an important step towards harmonization of methods for measuring SARS-CoV-2 RNA content and its results will undoubtedly be in demand to develop new PCR test systems or to improve the existing ones.

The presented results are not only consistent with each other, but also coincided with the results of alternative methods traceable to the International System of Units (SI). Such a large-scale demonstration of the equivalence of viral RNA quantitative assessment results will significantly improve testing reliability and will contribute to effective response to the pandemic.

The scientific vice-chancellor of the Pirogov Russian National Research Medical University, Dr. Denis Rebrikov, notes that the effectiveness of further medical care is directly related to modern laboratory technologies for studying the composition and properties of biological materials. Results of international pilot comparisons demonstrated once again that a good quality of measurements in the field of clinical laboratory diagnostics can be achieved through their traceability to measurement standards. Dr. Rebrikov also notes, that only three out of 21 participants used the necessary SARS-CoV-2 testing kits of their own design, Russia being among them.

There were no restrictions as to which research method should have been used – each participant was free to follow the BIPM recommendations or use their own unique developments. In most cases, participants used the method of digital PCR after reverse transcription (RT-dPCR).

The Acting Head of VNIIM, Dr. Anton Pronin, states that the laboratory infrastructure created at VNIIM allows high-precision measurements of quantitative indicators of nucleic acids - DNA and RNA content. Successful participation in the international comparisons of content measurements of genome fragments of RNA-containing SARS-CoV-2 and HIV-1 viruses confirmed the capabilities of Russian specialists to develop reference materials ensuring reliable results in laboratory medicine.

The Head of Bioinformatics Technology Laboratory of VNIIMS, Dr. Elena Kulyabina, notes that the use of reference materials as measurement standards will increase the accuracy of testing, thereby it will be possible to confirm the test sensitivity and specificity, i.e. the ability of a test to identify specifically SARS-CoV-2, distinguishing it from any other coronavirus.

Participants in the pilot comparison also note that the conducted study will contribute to form a scientific framework ensuring accuracy of similar molecular diagnostics methods, including those used to determine antiviral and antibacterial drug resistance or used for cancer diagnostics.

Reference: full information on the study conducted by the International Bureau of Weights and Measures (BIPM) can be found at https://www.bipm.org/en/news/full-stories/2020-12-nmi-covid.html