EXTERNAL QUALITY ASSESSMENT OF GLYCATED HEMOGLOBIN IN IRAN: COMPARISON OF FIVE DIFFERENT COMMERCIAL METHODS WITH TWO DIFFERENT TOTAL ALLOWABLE ERRORS.

Background: Glycated hemoglobin (HbA1c) measuring has a critical role in the monitoring and diagnosis of diabetes. So, the analytical performance of its measuring method must be acceptable. Clinical laboratories should continuously monitor the performance of their commercial methods, both by using proper internal quality control (IQC) and by participating in external quality assessment schemes (EQAS). Methods: In January and August 2016, two different freshly prepared commutable patient QC samples were sent to over 1000 laboratories, but 682 and 925 different laboratories which were used five common commercial methods for measuring HbA1c, included in this study during 23th and 24th runs of the external quality assessment program (EQAP), respectively. Target values for total group and also for peer groups were calculated. The performance of each method and laboratory were determined according to two different allowable total errors (TEa), including ±6% and ±20%, which are suggested by the National Glycohemoglobin Standardization Program (NGSP) and Reference Health Laboratory of Iran, respectively. Results: Considering TEa of ±20% in evaluating HbA1c commercial methods and laboratory performances, pass rates ranged from 97% to 98% during EQAP-23 and EQAP-24, respectively. But when this evaluation was performed according to TEa of ±6%, pass rates decreased significantly to 60% and 62%, respectively. Conclusions: Using improper analytical goals has led to misinterpretation of EQA results. In order to maintain the clinical usefulness of HbA1c results, we need to reduce TEa of ±20% to ±6% and improve HbA1c measuring method performance. Although, with TEa of ±6% our pass rates are not so bad. [ABSTRACT FROM AUTHOR]

Uvod: Merenje glikoliziranog hemoglobina (HbA1c) ima presudnu ulogu u praćenju i dijagnostikovanju dijabetesa. Zbog toga, metode za njegovo merenje moraju imati prihvatljive analitičke performanse. Kliničke laboratorije moraju stalno da prate performanse svojih komercijalnih metoda, kako korišćenjem odgovarajuće interne kontrole kvaliteta (IQC) tako i kroz učešće u šemama spoljne procene kvaliteta (EQAS). Metode: Tokom 23. i 24. kruga programa spoljne procene kvaliteta (EQAP), u januaru i avgustu 2016, dva različita sveže pripremljena komutabilna QC uzorka pacijenata poslata su u 682 i 925 različitih laboratorija koje koriste pet uobičajenih komercijalnih metoda za merenje HbA1c. Izračunate su ciljne vrednosti za ukupnu grupu i srodne grupe (peer groups). Rezultati: Performanse svake metode i laboratorije određene su u odnosu na dve različite dozvoljene ukupne greške (TEa), naime ±6% i ±20%, predložene od strane Nacionalnog programa za standardizaciju glikohemoglobina (NGSP) i Referentne zdravstvene laboratorije Irana. Kad se radi od TEa od ±20% u evaluaciji komercijalnih metoda za HbA1c i laboratorijskih performansi, stope prolaznosti (pass rates) bile su od 97% do 98% tokom EQAP-23 i EQAP-24. Međutim, kada je evaluacija izvršena prema TEa od ±6%, ove stope su se značajno smanjile na 60%, odnosno 62%. Zaključak: Korišćenje neodgovarajućih analitičkih ciljeva dovelo je do pogrešne interpretacije rezultata EQA. Kako bi se održala klinička korisnost rezultata HbA1c, potrebno je da snizimo TEa sa ±20% na ±6% i popravimo performanse metoda za merenje HbA1c. Mada, uz TEa od ±6%, naše stope prolaznosti i nisu bile tako loše. [ABSTRACT FROM AUTHOR]