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Quality assurance in molecular biochemical medical testing

As more advanced techniques are applied in the early diagnosis of cancer diseases, strict evaluation, approval and quality assurance are not only mandatory requirements, but also the foundation for test results to truly become effective tools to support diagnosis, treatment and patient care.

Báo Nhân dânBáo Nhân dân10/10/2025

Professor, Dr. Nguyen Huu Tu, President of Hanoi Medical University spoke.
Professor, Dr. Nguyen Huu Tu, President of Hanoi Medical University spoke.

On October 10, Hanoi Medical University in collaboration with Phacogen Institute of Technology organized a workshop on “Quality Assurance in Medical Testing”. The event attracted the participation of more than 100 experts, managers and representatives of hospitals and laboratories across the country. This is considered an important professional meeting place where the parties come together to update the standards, circulars, decrees of the Ministry of Health as well as the Law on Medical Examination and Treatment and share practical experiences in ensuring the quality of testing.

At the same time, the event is also a forum to propose solutions to comply with regulations, improve the quality and reliability of medical testing results in the context of international integration.

The value of molecular medicine testing

Medical testing is not only a diagnostic tool, but has become one of the important pillars in prognosis, treatment decision-making, monitoring and individualization of treatment. When the accuracy and reliability of the results are guaranteed, patients will have a more appropriate treatment regimen, minimizing risks and treatment costs.

Many places now do medical tests, but quality assurance is important. If the test is not done properly, it will have to be done multiple times, not only causing waste and damage but also affecting the patient's health.

Professor, Dr. Nguyen Huu Tu, Rector of Hanoi Medical University, said that to ensure each test result has accurate clinical value, medical facilities must not only strictly comply with professional procedures, but also regularly update and fully apply legal regulations, management standards as well as regulations on bidding and purchasing medical equipment such as machinery, supplies and biological products.

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Delegates attending the workshop.

In case the facility is not qualified to conduct on-site testing, it is necessary to cooperate with a reputable testing service provider. In that case, important criteria need to be set to evaluate the provider including: Capacity profile, laboratory facilities, machinery and reagents used, implementation process and staff, because this is what determines the accuracy of the results and the reputation of the medical facility.

In addition, Professor Nguyen Huu Tu emphasized that in the context of continuous technological innovation and many advanced techniques being applied in diagnosis, strict assessment, approval and quality assurance are not only mandatory requirements, but also the foundation for test results to truly become effective support tools for diagnosis, treatment and patient care.

“We appreciate Phacogen Technology Institute for pioneering advanced and specialized testing techniques, especially in ensuring testing quality standards. We hope that at the workshop, experts will share experiences, standardize more and more testing processes, techniques and in training, and invest in machinery to have standard and specific tests in the future,” Professor Tu shared.

The workshop recorded many in-depth reports revolving around key topics, from improving reliability in clinical biochemistry testing, standardizing molecular biology procedures in oncology to setting standards for genetic testing.

Experts emphasize that ensuring test quality is not only about the final results, but must be controlled throughout the entire process. That starts from collecting, preserving and transporting specimens, to the stages of testing, analysis and returning results.

In particular, during the testing process, the machinery, equipment and chemicals used must all be IVD standard medical equipment. In parallel, the laboratory must continuously conduct internal audits and participate in periodic external audits to ensure accuracy and reliability.

Orientation for sustainable development of medical testing industry

In the context that many medical facilities are not qualified to fully deploy specialized testing techniques and use advanced technology, cooperation with testing service providers has become popular. This raises an urgent requirement: How to choose a reliable testing service provider, ensuring professional quality and clinical value of the results.

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Associate Professor, Doctor, Specialist II, Resident Doctor Le Trung Tho - Director of the Center for Pathology and Molecular Biology, Central Lung Hospital spoke.

Sharing about this issue, Associate Professor, Doctor, Specialist II, Resident Doctor Le Trung Tho - Director of the Center for Pathology - Molecular Biology, Central Lung Hospital said that a few years ago, the whole country had only one pathology unit that achieved ISO quality certification, now it has increased to nearly 10 facilities. Vietnam has about 700 pathologists.

Many units have to expand molecular biological testing, especially in cancer diagnosis and treatment, but not all test results are trusted by patients and clinicians.

"In order for a testing unit to provide reliable results, it must meet the criteria of having equipment and facilities that ensure quality requirements; having a team of professional technicians; using modern equipment, provided by reputable sources such as central and provincial hospitals. Testing machines and equipment must be calibrated according to the correct process; chemicals and testing equipment as well as analysis software must meet IVD standards, have a clear origin, ensuring accurate and reliable test results," said Associate Professor Le Trung Tho.

This expert also emphasized the issue of quality control and legality: The entire process from receiving samples, processing, analyzing to returning results must be transparent, with full tracking records; strictly comply with professional standards and current legal regulations, ensuring that test results are both accurate and have legal value when used in diagnosis, treatment or research.

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A lot of scientific information about molecular biology testing was shared at the workshop.

Faced with the reality that many units providing molecular biology testing services are not licensed or certified for quality, and are only for research or advertising purposes, Dr. Tho recommends that people who want to perform genetic cancer screening tests themselves should choose medical facilities that have been licensed and recognized for quality by the state.

However, Dr. Tho also hopes that health insurance will soon cover molecular biological tests in cancer diagnosis and treatment so that people can access effective testing methods and early screening for diseases.

Source: https://nhandan.vn/bao-dam-chat-luong-trong-xet-nghiem-y-hoc-sinh-hoa-phan-tu-post914273.html


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