Open AccessEvaluation of a new hemoglobin A1c analyzer for point‐of‐care testing
Author(s) -
Zhou Rui,
Wang Wei,
Song ZhiXin,
Tong Qing,
Wang QingTao
Publication year - 2018
Publication title -
journal of clinical laboratory analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.536
H-Index - 50
eISSN - 1098-2825
pISSN - 0887-8013
DOI - 10.1002/jcla.22172
Subject(s) - point of care testing , medicine , spectrum analyzer , concordance , reproducibility , receiver operating characteristic , point of care , concordance correlation coefficient , diabetes mellitus , accuracy and precision , diagnostic accuracy , correlation coefficient , coefficient of variation , nuclear medicine , pathology , statistics , mathematics , endocrinology , computer science , telecommunications
Background There has been an increasing desire for the use of point‐of‐care testing ( POCT ) by both primary care clinicians and patients. This study aimed to evaluate the performance of a new POCT analyzer for hemoglobin A1c (HbA1c) testing. Methods We assessed the accuracy, precision, and linearity of the POCT HbA1c analyzer (A1C EZ 2.0) with the Tosoh G8 Analyzer as comparative instrument, following the Clinical and Laboratory Standards Institute ( CLSI ) protocols. We evaluated sensitivity and specificity of the A1C EZ 2.0 in the clinical diagnosis of diabetes among 842 subjects from 79 communities in Beijing, China. Results Using regression analysis, the slope of the A1C EZ 2.0 vs the Tosoh G8 Analyzer was 0.9938, with an intercept of 0.0964 and a concordance correlation coefficient of 0.978. For precision, the reproducibility of CV ( CV T ) were 3.7% and 2.7% at a lower (36 mmol/mol (5.4%)) and higher (107 mmol/mol (11.9%)) level of HbA1c respectively. The area under the receiver operating characteristic ( ROC ) curve for clinical diagnosis of diabetes was 0.911 with the HbA1c cut‐off value of 44 mmol/mol (6.14%). At the HbA1c level of 48 mmol/mol (6.5%), the sensitivity and specificity were76.1% and 86.6%. Conclusion The A1C EZ 2.0 has a high accuracy and precision, with a wide range of linearity, compared to a comparative laboratory instrument. It met analytical quality specifications and could be suitable for the clinical management of diabetes mellitus.