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In reality, no single factor can guarantee accurate test results without being part of a comprehensive quality management system. Every stage — from sample collection and processing to analysis and reporting — must operate in a synchronized, controlled, and traceable manner. This system is the true foundation that ensures test results are accurate, consistent, and reliable. This is especially crucial in the field of genetic testing, where even the smallest error can lead to serious consequences for the patient, making a tightly managed system an absolute necessity.

True Quality Comes from a Structured and Unified Operational System

Dr. Nguyen Quang Vinh – Director, GENTIS Laboratory Center

Test results are not simply the output of machines or test kits; they are the outcome of a complex, interconnected process — from input sample evaluation and standardized analysis protocols (PCR, sequencing, NGS), to internationally-aligned data interpretation and practical clinical reporting. Every step serves as a quality control checkpoint, and a single mistake can have serious implications for diagnosis and treatment.

Furthermore, laboratory quality is enhanced through the diversity of equipment and the application of advanced technologies that effectively handle the wide range of complexities in modern medicine. Relying on a single technology, test kit, or device is an outdated approach and no longer suitable for building a high-quality testing system.

Establishing a comprehensive quality management system not only minimizes risks but also fosters strong trust among laboratories, physicians, and patients. When processes are tightly controlled, results are accurate, consistent, and traceable — key criteria that physicians rely on for treatment decisions and that give patients confidence in their test outcomes.

CAP – The Gold Standard in Laboratory Quality Management

Dr. Pham Dinh Minh – Director of R&D, GENTIS (Left) with CAP Representative at GENTIS Laboratory

The CAP (College of American Pathologists) certification is recognized globally as the gold standard in clinical laboratory quality. To earn this certification, laboratories must meet stringent requirements and establish a comprehensive quality management system aligned with international standards. This includes participation in regular external quality assessments, expert evaluations, complete data traceability, and continuous quality improvement.

The CAP standard does not assess equipment or personnel in isolation, but evaluates the entire laboratory operation. Everything from standard operating procedures, sample control, technical performance validation, result analysis, to traceability and incident handling — all must meet the highest benchmarks. As a result, a CAP-certified quality system ensures high accuracy, complete transparency, and maximum patient safety.

Another advantage of CAP certification is its support in effectively applying ISO standards in Vietnam by supplementing them with specialized technical requirements. The integration of CAP with ISO 15189 creates a comprehensive framework that enhances both operational efficiency and technical quality. Vietnamese laboratories achieving CAP certification not only meet global standards but also improve practical operations and result accuracy.

“CAP standards bring tangible value to many stakeholders. For doctors, CAP certification is a key factor that ensures confidence in test accuracy, helping them personalize treatment plans, shorten diagnosis time, and reduce retesting — saving time and cost for patients. For customers, testing at a CAP-certified lab means access to a modern, reliable, internationally compatible system — especially beneficial for patients seeking treatment abroad, as results are widely recognized without the need for retesting. High-quality results also reduce errors and enhance peace of mind in healthcare. In addition, partners working with CAP-certified labs like Gentis gain opportunities for sample exchange, data sharing, clinical research, and providing international-standard services, expanding collaboration and development in the medical field,” shared Dr. Pham Dinh Minh (Director of CAP Laboratory, Gentis - Eurofins).

Gentis – Differentiated by CAP-Standard Quality System

Dr. Tar-Choon Aw – Laboratory Director, Changi General Hospital, CAP Expert (Far Right) working with GENTIS experts

In Vietnam, Gentis is one of the pioneers in building a high-quality genetic testing system that meets international standards. Achieving CAP certification is not just a testament to the continuous commitment to quality improvement, but also affirms Gentis’s unique position in applying a globally standardized quality management system for genetic testing in Vietnam.

While many facilities focus their messaging on technology, equipment, test kits, or technician expertise, Gentis understands that true quality comes from a complete quality management system. A systematic and consistent framework is the key to ensuring trustworthy results. Gentis not only invests in modern equipment but also establishes a tightly controlled quality chain — from sample collection and processing to result reporting. All testing data at Gentis is stored, traceable, and controlled according to ISO standards, and strictly complies with CAP certification requirements.

“When doctors receive test results from Gentis, they’re not just getting a number — they’re receiving an internationally certified result backed by a rigorous quality system. This is what fundamentally sets Gentis apart from units that only invest in technology or technician training. Test quality cannot stem from a single factor — it must be the outcome of a cohesive, tightly controlled system,” emphasized Dr. Pham Dinh Minh

With its CAP certification, Gentis affirms its commitment to quality — not merely in words but through concrete action — serving as clear evidence of its sustainable and truly differentiated path in the field of genetic testing in Vietnam.