Medical device quality in molecular biology testing

Monday, 22/05/2023 | 16:56

Molecular biology testing is a breakthrough in the field of diagnostics, widely applied in various domains.

With its rapid and accurate results, molecular biology testing aids in early diagnosis for the prevention and timely treatment of many infectious, cancer-related, and reproductive disorders.

Molecular biology testing enables quick and accurate identification of disease-causing viruses, facilitating prompt diagnosis and treatment. Through gene sequencing methods, molecular biology testing also yields positive outcomes in screening, diagnosing, and treating common cancers such as breast and cervical cancer, as well as detecting genetic abnormalities in reproductive support.

The effectiveness and quality of molecular biology testing depend on several factors, including the testing method, testing equipment, sample quality, and the proficiency of the technician.

Molecular biology testing is widely applied in various fields.

Molecular biology testing methods are widely used today

There are numerous molecular biology testing methods available, but the most commonly used ones nowadays are Real-time PCR and gene sequencing.

Real-time PCR (polymerase chain reaction) is an improvement of the PCR method, which amplifies DNA to create multiple copies from a single DNA molecule based on thermal cycling, allowing for the rapid identification of disease-causing microorganisms. Real-time PCR requires high-quality standards for comparison and provides accurate quantitative results. It offers the advantage of quick turnaround time and high accuracy.

Gene sequencing is a technique used to determine the specific sequence of DNA. Through various stages of development, gene sequencing technologies have undergone new advancements with several advantages, including simpler procedures, higher efficiency, and lower costs. The latest gene sequencing technology known as Next-Generation Sequencing (NGS) is capable of sequencing millions of DNA segments simultaneously and has been effectively applied in the diagnosis and treatment of various genetic disorders.

NGS (Next Generation Sequencing) genomic sequencing is a new breakthrough in molecular biology.

Technicians require a high level of proficiency

Starting with the detection and isolation of the first DNA molecules in the 1980s, the field of molecular biology has made remarkable advancements in research and applications. Unlike traditional testing methods, modern molecular biology testing methods are increasingly progressing with many processes automated using state-of-the-art technology. Therefore, technicians not only need to have a solid understanding of their field but also the ability to quickly grasp and adapt to new technologies.

Technicians have a high level of proficiency and skill.

Equipment plays a crucial role in molecular biology testing

Machinery and testing kits are indispensable equipment that directly influence the results of molecular biology testing in the laboratory. The equipment systems used for molecular biology testing can be classified into two types: fully automated and semi-automated. Depending on the scale, cost, and purpose, healthcare facilities choose the appropriate system.

Fully automated systems consist of interconnected modules where technicians have little or no involvement in the testing process. The advantage of fully automated systems is high accuracy. However, the drawback is the high cost due to the requirement of synchronized machinery systems and corresponding testing kits.

Semi-automated systems require technicians to perform certain manual steps before analyzing the samples. The advantage of this system is the ability to use and calibrate multiple types of commercially available kits, resulting in lower costs suitable for the majority of users in Vietnam. However, achieving the required accuracy with this system demands highly experienced technicians.

Phacogen Pharmaceutical Joint Stock Company is a leading corporation in providing the most advanced molecular biology testing and diagnostic solutions. They offer solutions that meet the requirements for both fully automated and semi-automated systems in healthcare facilities.

Lab technician is operating Illumina's sequencing instrument

Various types of molecular biology testing equipment are imported from well-known brands worldwide, such as the Opentron and Hamilton automated robot systems, Panagene extraction machines, Illumina gene sequencing machines, and IVD standard testing kits from companies like Ngenbio, Panagen, and GeneProof.

Additionally, Phacogen factory, which has been operational since 2021, has introduced its own line of IVD-standard molecular biology testing kits. These kits offer competitive pricing, high accuracy, and compatibility with various testing machines.

Phacogen kit tests at Medi-pharm 2023

Phacogen factory operates under a quality management system that meets the EN ISO 13485:2016 standard, certified by TUV Rheinland. The products manufactured at the factory have undergone a rigorous approval process for safety and effectiveness and are currently being widely distributed in healthcare facilities and testing laboratories nationwide.

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