Abstract
BackgroundGlobally, all medical laboratories seeking accreditation should meet international quality standards to perform certain specific tests. Quality management program provides disciplines targeted to ensure that quality standards have been implemented by a laboratory in order to generate correct results. The hallmark of the accreditation process is method verification and quality assurance. Before introducing a new method in your laboratory, it is important to assess certain performance characteristics that reflect the concept of method verification.MethodsIn this review, we illustrated how to verify the performance characteristics of a new method according to the recent guidelines. It includes an assessment of precision, trueness, analytical sensitivity, detection limits, analytical specificity, interference, measuring range, linearity, and measurement uncertainty.ConclusionsAlthough the presence of several updated guidelines used to determine the performance characteristics of new methods in clinical chemistry laboratories, the real practice raised several concerns with the application of these guidelines which in need for further consideration in the upcoming updates of these guidelines.
Highlights
The hallmark of the health care process in a country is the correct diagnosis, risk factor assessment, effective prophylactic and curative handling of the diseases
Quality control can be assigned as an internal control that is performed by laboratories offering the day to day basis working quality assurance or external control performed by many laboratories, and their results are statistically compared and evaluated for proficiency testing [4]
There have been several publications discussing the guidelines of method validation and verification adopted by national and international organizations, regulated and used by ISO 17025, ISO 15189 or by the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) [7] either generally [7,8,9,10,11,12,13,14,15] or in the analytical chemistry [16, 17], toxicology [18], chemical pathology [19], food and drugs industry [20, 21]
Summary
All medical laboratories seeking accreditation should meet international quality standards to perform certain specific tests. Before introducing a new method in your laboratory, it is important to assess certain performance characteristics that reflect the concept of method verification. Methods: In this review, we illustrated how to verify the performance characteristics of a new method according to the recent guidelines. It includes an assessment of precision, trueness, analytical sensitivity, detection limits, analytical specificity, interference, measuring range, linearity, and measurement uncertainty. Uvod: Sve medicinske laboratorije koje trae akreditaciju treba da ispunjavaju me|unarodne standarde kvaliteta kako bi mogle da sprovode odre|ene specifi~ne testove. Vano je da pre uvo|enja nove metode u va{u laboratoriju procenite odre|ene karakteristike performansi koje odraavaju koncept metode verifikacije. List of abbreviations: ILAC, International Laboratory Accreditation Cooperation; VIM3, International Vocabulary of Metrology 3; CLIA 88, Clinical Laboratory Improvement Amendments of 1988; SD, Standard deviation; CV, Coefficient of variation; TEa, Total error allowable; BNP, B-natriuretic peptide; PSA, Prostate-specific antigen; LD, Lactate dehydrogenase; TV, Target value; TSH, Thyroid-stimulating hormone; HIL, haemolysis/icterus/lipaemia; AMR, Analytical measurement range; CRR, Clinical reportable range; LOB, Limit of blank; LOD, Limit of detection; LOQ, Limit of quantification
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