Ann Lab Med.  2014 Sep;34(5):367-371. 10.3343/alm.2014.34.5.367.

Working Towards Accreditation by the International Standards Organization 15189 Standard: How to Validate an In-house Developed Method an Example of Lead Determination in Whole Blood by Electrothermal Atomic Absorption Spectrometry

• Garcia Hejl C
• Ramirez JM
• Vest P
• Chianea D
• Renard C

• KMID: 1791951
• DOI: http://doi.org/10.3343/alm.2014.34.5.367

Abstract

Laboratories working towards accreditation by the International Standards Organization (ISO) 15189 standard are required to demonstrate the validity of their analytical methods. The different guidelines set by various accreditation organizations make it difficult to provide objective evidence that an in-house method is fit for the intended purpose. Besides, the required performance characteristics tests and acceptance criteria are not always detailed. The laboratory must choose the most suitable validation protocol and set the acceptance criteria. Therefore, we propose a validation protocol to evaluate the performance of an in-house method. As an example, we validated the process for the detection and quantification of lead in whole blood by electrothermal absorption spectrometry. The fundamental parameters tested were, selectivity, calibration model, precision, accuracy (and uncertainty of measurement), contamination, stability of the sample, reference interval, and analytical interference. We have developed a protocol that has been applied successfully to quantify lead in whole blood by electrothermal atomic absorption spectrometry (ETAAS). In particular, our method is selective, linear, accurate, and precise, making it suitable for use in routine diagnostics.

Keyword

Validation; Lead; Atomic absorption spectrophotometry

MeSH Terms

Accreditation
Humans
Laboratories/standards
Lead/*blood/standards
Reference Standards
*Spectrophotometry, Atomic/standards
*Validation Studies as Topic
Lead