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

Antonio Capalbo; Amy E T Sparks; Dhruti Babariya; G David Ball; Elvezia M Paraboschi; Christian S Ottolini

doi:10.1016/j.fertnstert.2025.05.158

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

Journal article

Peer reviewed

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

Antonio Capalbo, Amy E T Sparks, Dhruti Babariya, G David Ball, Elvezia M Paraboschi and Christian S Ottolini

Fertility and sterility, Vol.124(5 Pt 1), pp.860-869

11/01/2025

DOI: 10.1016/j.fertnstert.2025.05.158

PMID: 41106954

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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.

Pregnancy

Female

Fertilization in Vitro - standards

Genetic Testing - ethics

Genetic Testing - methods

Genetic Testing - standards

Humans

Predictive Value of Tests

Preimplantation Diagnosis - ethics

Preimplantation Diagnosis - methods

Preimplantation Diagnosis - standards

Quality Assurance, Health Care

Quality Control

Reproducibility of Results

Details

Title: Subtitle: Ongoing surveillance of analytical platforms in preimplantation genetic testing: phase 4
Creators: Antonio Capalbo - University of Chieti-Pescara
Amy E T Sparks - University of Iowa
Dhruti Babariya - Juno Genetics UK, Reproductive Genetics, Oxford, United Kingdom
G David Ball - Henry Ford Health System
Elvezia M Paraboschi - Juno Genetics Italy, Reproductive Genetics, Rome, Italy
Christian S Ottolini - University College London
Resource Type: Journal article
Publication Details: Fertility and sterility, Vol.124(5 Pt 1), pp.860-869
DOI: 10.1016/j.fertnstert.2025.05.158
PMID: 41106954
NLM abbreviation: Fertil Steril
ISSN: 0015-0282
eISSN: 1556-5653
Publisher: Elsevier
Language: English
Date published: 11/01/2025
Academic Unit: Obstetrics and Gynecology
Record Identifier: 9985016011902771

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