Background: We present a study aimed to define the analytical goals for the determination of hemoglobin A2 , a minor hemoglobin present in human blood normally accounting from 2.5 % to 3.3 % of total hemoglobin, and typically increased up to 6 % - 7 % in subjects carriers of β -thalassemia. Methods: The analytical goals have been derived using two approaches, the first one based on biologic variation, and the second one based on the opinion of experts. Results: The data obtained by studying 17 adult non-carrier healthy subjects, from whom we took blood samples every 2 weeks for 2.0 months, indicated a small intraindividual biologic variation (CVI of 0.7 % ), with respect to a larger between-subject variation (CVG of 7.7 % ). The minimum levels for imprecision, bias and total error derived from the analysis of these data were: 0.5 % , 2.9 % and 4.5 % , respectively. The limits derived from the opinion of experts were based on a questionnaire with three clinical cases, which was circulated among two teams of international experts, and on a discussion about the clinical needs. The average total error derived from such surveys ranged between 7.0 % and 9.5 % . Conclusions: The various methods to derive analytical performance goals gave different limits, thus indicating the need for an increased communication between clinicians and laboratory professionals on this matter.

Analytical goals for the determination of HbA₂ / A. Mosca, R. Paleari, B. Wild. - In: CLINICAL CHEMISTRY AND LABORATORY MEDICINE. - ISSN 1434-6621. - 51:5(2013 May), pp. 937-941.

Analytical goals for the determination of HbA₂

A. Mosca;R. Paleari;
2013-05

Abstract

Background: We present a study aimed to define the analytical goals for the determination of hemoglobin A2 , a minor hemoglobin present in human blood normally accounting from 2.5 % to 3.3 % of total hemoglobin, and typically increased up to 6 % - 7 % in subjects carriers of β -thalassemia. Methods: The analytical goals have been derived using two approaches, the first one based on biologic variation, and the second one based on the opinion of experts. Results: The data obtained by studying 17 adult non-carrier healthy subjects, from whom we took blood samples every 2 weeks for 2.0 months, indicated a small intraindividual biologic variation (CVI of 0.7 % ), with respect to a larger between-subject variation (CVG of 7.7 % ). The minimum levels for imprecision, bias and total error derived from the analysis of these data were: 0.5 % , 2.9 % and 4.5 % , respectively. The limits derived from the opinion of experts were based on a questionnaire with three clinical cases, which was circulated among two teams of international experts, and on a discussion about the clinical needs. The average total error derived from such surveys ranged between 7.0 % and 9.5 % . Conclusions: The various methods to derive analytical performance goals gave different limits, thus indicating the need for an increased communication between clinicians and laboratory professionals on this matter.
Analytical goals; Biologic variation; Hemoglobin A2; Reference systems
Settore BIO/12 - Biochimica Clinica e Biologia Molecolare Clinica
Article (author)
File in questo prodotto:
File Dimensione Formato  
2013_Analytical goals A2.pdf

accesso riservato

Tipologia: Publisher's version/PDF
Dimensione 375.38 kB
Formato Adobe PDF
375.38 kB Adobe PDF   Visualizza/Apri   Richiedi una copia
Pubblicazioni consigliate

Caricamento pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/226469
Citazioni
  • ???jsp.display-item.citation.pmc??? 0
  • Scopus 9
  • ???jsp.display-item.citation.isi??? 7
social impact