CAP – The Gold Standard of International Quality for Genetic Testing Laboratories
According to Dr. Nguyen Quang Vinh – Director of GENTIS Testing Center – the CAP accreditation is one of the most rigorous and comprehensive laboratory quality control standards in the world. Unlike ISO 15189, the Vietnamese standard – which can be granted for just one test in a lab – CAP requires all tests performed in the laboratory to be periodically validated and monitored by international experts. Every aspect, from software systems and equipment to each step performed by technicians, must comply with strict standards.
This ensures that test results from CAP-accredited laboratories like GENTIS are not only accurate, safe, and secure but also recognized globally – expanding the lab’s service capabilities beyond national borders to reach international markets.
In the field of assisted reproduction, Dr. Nguyen Minh Duc – Head of the Assisted Reproduction Laboratory at Hanoi Hospital of Andrology and Infertility – emphasizes the critical importance of accuracy in techniques such as PGT (Preimplantation Genetic Testing) and NIPT (Non-Invasive Prenatal Testing). For IVF cases requiring PGT, seamless coordination between the Embryology Lab and the Genetics Lab is essential. He noted: “Currently, the rate of inconclusive results in genetic testing is just 1–2%. This is extremely positive because even a 1% improvement can bring hope to thousands of families struggling with infertility.”
What makes the difference is GENTIS's fully integrated testing system, which strictly controls every step: from sample collection and transportation to testing and result reporting. All processes follow CAP-standard protocols, ensuring maximum reliability for clinicians when making treatment decisions.
In Vietnam, although testing technologies are approaching international standards, the human factor still plays a significant role in laboratory operations. Dr. Vinh shared that CAP enforces special monitoring protocols at critical control points where errors are most likely to occur, helping to minimize risks. Each sample is tracked throughout its entire journey using specialized software, while equipment and technicians must strictly adhere to protocols. Results are only released once all CAP criteria are met.
CAP – Enhancing Collaboration Between Genetic and IVF Laboratories
One of the standout advantages agreed upon by both experts is that CAP accreditation improves collaboration between labs, particularly between Embryology Labs and Genetic Labs. According to Dr. Đức, embryology labs operate according to the embryo’s developmental timeline, so the handover and processing of samples must follow a standardized and tightly coordinated workflow. Addressing the timing and personnel challenges faced by embryology labs, Dr. Vinh added: “The GENTIS lab operates 24/7, ready and flexible to handle any situation to ensure that samples are not delayed or disrupted – a crucial factor in IVF.”
