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[Considerations on delocalized HbA1c assays]
M Bordas-Fonfrède1, J Sélam, J Goudable
1Laboratoire Central de Biochimie, Groupe Hospitalier Pitié-Salpêtrière, Paris.
Insights
Delocalized hemoglobin A1c (HbA1c) testing improves diabetes management by informing therapy adjustments and patient motivation. These point-of-care assays require standardization and collaboration between clinicians and biologists for effective implementation.
Area of Science:
- Clinical Chemistry
- Point-of-Care Testing
- Diabetes Management
Background:
- Hemoglobin A1c (HbA1c) knowledge is crucial for diabetologists to optimize therapy and enhance patient motivation.
- Delocalized HbA1c assays are requested to provide immediate results during consultations, similar to other point-of-care testing applications.
- While not directly impacting life prognosis, delocalized testing offers significant clinical benefits.
Purpose of the Study:
- To review the rationale behind implementing delocalized HbA1c assays.
- To outline the steps involved in the practical implementation of these assays.
- To emphasize the essential collaboration between clinicians and biologists for successful integration.
Main Methods:
- Review of existing literature and guidelines on delocalized HbA1c testing.
- Discussion of technical requirements for immunological delocalized assays, including standardization and quality control.
- Consideration of practical aspects such as clinician expertise, biologist roles, and cost-effectiveness.
Main Results:
- Immunological methods are a common solution for delocalized HbA1c testing.
- These assays must adhere to laboratory standards and "Guide de Bonne Exécution des Analyses de Biologie Médicale" (GBEA) rules.
- Successful implementation necessitates a balance between technical requirements, clinical utility, and economic viability.
Conclusions:
- Delocalized HbA1c assays offer valuable support for diabetes care by enabling timely therapeutic decisions and improving patient engagement.
- The effective use of these point-of-care tests relies on rigorous standardization, quality control, and a strong collaborative framework between clinical and biological professionals.
- Addressing practical constraints, including cost and specific expertise, is vital for widespread adoption and optimal patient outcomes.
Abstract:
Availability and knowledge of HbA(1c) value during consultation is an important feature for diabetologists, that permits a better adaptation of therapy and a better motivation of patients. This expectation explains the request for delocalized assays of HbA(1c), even though life prognosis is not affected, like in the other cases of point of care testing. One of the most frequent solutions is the use of immunological delocalized HbA(1c) assays. Technically, these methods have to meet the same criteria as those used in laboratories. They have to be standardized, and controlled according to the "Guide de Bonne Exécution des Analyses de Biologie Médicale" (GBEA) rules. Solutions chosen for delocalization must respect specific skills of clinicians and biologists and cope with cost limitations. This paper reviews rationales for delocalized HbA(1c) assays, steps of their implementation, and their use in practical routine, with a special emphasis given on the necessary complementarity between clinicians and biologists.