PMID- 30584398
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231005
IS  - 1452-8258 (Print)
IS  - 1452-8266 (Electronic)
IS  - 1452-8266 (Linking)
VI  - 37
IP  - 4
DP  - 2018 Dec
TI  - External Quality Assessment of Glycated Hemoglobin in Iran: Comparison of Five 
      Different Commercial Methods with Two Different Total Allowable Errors.
PG  - 397-405
LID - 10.1515/jomb-2017-0057 [doi]
AB  - BACKGROUND: Glycated hemoglobin (HbA(1c)) 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 HbA(1c), included in this study during 23(th) 
      and 24(th) 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 HbA(1c) 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 HbA(1c) results, we need to reduce TEa of 
      +/-20% to +/-6% and improve HbA(1c) measuring method performance. Although, with TEa 
      of +/-6% our pass rates are not so bad.
FAU - Atabi, Fereshteh
AU  - Atabi F
AD  - Department of Biochemistry and Pharmacology, Islamic Azad University, Tehran 
      Medical Sciences Branch, Tehran, Iran.
FAU - Mohammadi, Reza
AU  - Mohammadi R
AD  - Department of Biochemistry and Pharmacology, Islamic Azad University, Tehran 
      Medical Sciences Branch, Tehran, Iran.
AD  - Department of Biochemistry of External Quality Assessment Program, Iranian 
      Association of Clinical Laboratory Doctors, Tehran, Iran.
LA  - eng
PT  - Journal Article
DEP - 20181201
PL  - Serbia
TA  - J Med Biochem
JT  - Journal of medical biochemistry
JID - 101315490
PMC - PMC6298484
OTO - NOTNLM
OT  - EQA
OT  - HbA1c
OT  - analytical goals
OT  - glycated hemoglobin
COIS- Conflict of interest statement: The authors stated that they have no conflicts of 
      interest regarding the publication of this article.
EDAT- 2018/12/26 06:00
MHDA- 2018/12/26 06:01
PMCR- 2018/12/01
CRDT- 2018/12/26 06:00
PHST- 2017/09/24 00:00 [received]
PHST- 2017/12/25 00:00 [accepted]
PHST- 2018/12/26 06:00 [entrez]
PHST- 2018/12/26 06:00 [pubmed]
PHST- 2018/12/26 06:01 [medline]
PHST- 2018/12/01 00:00 [pmc-release]
AID - jomb-2017-0057 [pii]
AID - 10.1515/jomb-2017-0057 [doi]
PST - epublish
SO  - J Med Biochem. 2018 Dec 1;37(4):397-405. doi: 10.1515/jomb-2017-0057. eCollection 
      2018 Dec.