Diagnosing Diabetes Mellitus: Performance of Hemoglobin A^sub 1c^ Point-of-Care Instruments in General Practice Offices

Hemoglobin A^sub lc^ (Hb A^sub lc^) measurement by hospital laboratory instruments, but not by point-of-care (POC) instruments, has been recommended for use to diagnose diabetes mellitus. We evaluated results from 13 Hb A^sub lc^ external quality assurance (EQA) surveys over a 6-year period in Norwa...

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Bibliographic Details
Published inClinical chemistry (Baltimore, Md.) Vol. 59; no. 12; p. 1790
Main Authors Sølvik, Una Ørvim, Røraas, Thomas, Christensen, Nina Gade, Sandberg, Sverre
Format Journal Article
LanguageEnglish
Published Washington Oxford University Press 01.12.2013
Subjects
Advantages
Diabetes
Hemoglobin
Laboratories
Polls & surveys
Quality assurance
Specifications
Studies
Norway
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Summary:Hemoglobin A^sub lc^ (Hb A^sub lc^) measurement by hospital laboratory instruments, but not by point-of-care (POC) instruments, has been recommended for use to diagnose diabetes mellitus. We evaluated results from 13 Hb A^sub lc^ external quality assurance (EQA) surveys over a 6-year period in Norway, from both POC instruments used in general practice (GP) offices and instruments in hospital laboratories, against the analytical quality specifications recommended for use of Hb A^sub lc^ to diagnose diabetes mellitus. All GP offices (n = 1288) and hospital laboratories (n = 52) measuring Hb Alc in Norway participated in the EQA survey. The percentage of participants that performed measurements within the quality specifications was calculated. Pooled within-laboratory CVs were estimated for the Afinion, DCA 2000, DCA 2000+, DCA Vantage(TM), and Nycocard Hb A^sub lc^ Reader instruments and for hospital laboratory instruments. Between 60% to 90% of Afinion and DCA users and hospital laboratories performed Hb Alc measurements within the quality specifications for both trueness (6.0%) and imprecision (CV <2.0%) at 2 levels in each EQA survey. The pooled within-laboratory CVs for the Afinion and DCA instruments and hospital laboratories were below the recommended limit of 2.0% for most of the surveys. A large proportion of GP offices using Afinion and DCA POC instruments to measure Hb Alc fulfill the analytical quality specifications for diagnosing diabetes mellitus, and these instruments demonstrate analytical quality comparable to that of hospital laboratory instruments. When GP offices participate in a stringent quality assurance program and generate Hb Alc measurements that meet analytical quality specifications, these measurements can be recommended for use to diagnose diabetes mellitus. [PUBLICATION ABSTRACT]
ISSN:0009-9147
1530-8561