[Recommendations for aminoacids chromatography analysis]

Area of Science:

• Biochemistry
• Medical Diagnostics
• Analytical Chemistry

Background:

• Hereditary metabolic diseases require detecting numerous compounds for biochemical diagnosis.
• Metabolic profiling and amino acid chromatography are key diagnostic tools.
• Accreditation ensures the reliability of medical laboratory examinations.

Purpose of the Study:

• To recommend an approach for accrediting amino acid chromatography.
• To discuss validation parameters within the NF EN ISO 15189 framework.
• To ensure accurate identification and quantification of amino acids.

Main Methods:

• Amino acid chromatography for identifying and quantifying over forty compounds.
• Validation parameter assessment according to NF EN ISO 15189 standards.
• Methodological recommendations for accreditation.

Main Results:

• A framework for accrediting amino acid chromatography has been proposed.
• Key validation parameters and recommendations are detailed.
• The study supports the reliable use of amino acid chromatography in diagnostics.

Conclusions:

• Accreditation of amino acid chromatography is essential for accurate hereditary metabolic disease diagnosis.
• The proposed approach ensures the quality and reliability of the method.
• This work aids medical laboratories in meeting accreditation requirements.