Ongoing surveillance of analytical platforms in preimplantation genetic testing: phase 4

Abstract

The advancement of reproductive genetics testing, particularly preimplantation genetic testing, has revolutionized the field of assisted reproductive technologies. However, once a testing protocol is established, analytical and clinical validation, rigorous monitoring and evaluation become imperative to ensure the reliability of results and patient safety. This article explores the necessity to continually monitor the clinical outcomes and assay stability within reproductive genetics testing centers and collaborating in vitro fertilization clinics and laboratories, emphasizing the need for extensive data accumulation, robust quality control and quality assurance measures, follow-up monitoring and careful follow-up management of abnormal pregnancy results. Furthermore, it briefly discusses the legal and ethical obligations of genetics and in vitro fertilization laboratory directors as well as clinicians to ensure the accuracy and effectiveness of reproductive genetics testing protocols. In essence, proper and continuous quality control/quality assurance/surveillance of analytical platforms and clinical results is fundamental to guarantee that clinical performance is consistent with that observed in technical and clinical validations of assays, ensuring that promised benefits to patients are delivered.