Comparison of POCT glucose meters and analysis of the interference factor

Author:

Wang Qian1,Du Jin2,Chen Lin3,Du Yu-di4,Luo Wei1ORCID

Affiliation:

1. Department of Clinical Laboratory , Tianjin Medical University General Hospital , Tianjin , P.R. China

2. Department of Anesthesia , Tianjin Medical University General Hospital , Tianjin , P.R. China

3. Department of Medical Laboratory , Tianjin Medical University , Tianjin , P.R. China

4. Department of Traditional Chinese Medicine , Chengde Medical College , Chengde , P.R. China

Abstract

Abstract Objectives Not many reports have covered large-scale point of care testing (POCT) blood glucose comparisons, and many interfering factors affect detection. This study aims to verify the performance of POCT blood glucose meters and discusses the factors that interfere with detection. Methods Accuracy and precision verification in five glucose concentration groups-high 1 (H1), High 2 (H2), medium 1 (M1), medium 2 (M2), and low (L); comparison of different test methods and specimens; and also the influence of iodophor was investigated in a dilution experiment. Results A total of 58 out of 64 Accu-Chek Inform II POCT blood glucose meters (ACI II) qualified for testing. A proportional significant difference in the relative bias was observed with the POCT instruments in the intermediate and high glucose concentration groups (H=15.364, p=0.02). There were significant differences among the five groups with compliance rates (χ 2=21.03, p=0.00); Group L showed higher values than groups H1 and H2. The precision verification met the requirements issued by the Consensus. Significant differences were found between the three detection methods. The measurement of the Glucose Oxidase Method (Cobas B 123) was lower than that of the HITACHI Plasma Hexokinase Method and the Glucose Dehydrogenase Method on the ACI II (p=0.005 and 0.003) in the preliminary study. No differences were seen among the three types of specimens (p>0.05). The glucose results were incorrect in the presence of iodophor interference. Conclusions The ACI II and Cobas B123 (with a slightly negative bias) provide sufficiently accurate measurements, and all types of blood specimens can be applied. Iodophor, a disinfectant, interferes with glucose measurement.

Publisher

Walter de Gruyter GmbH

Subject

Biochemistry (medical),Clinical Biochemistry,Discrete Mathematics and Combinatorics

Reference18 articles.

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2. Zhou, R, Wang, Q. Opportunities and challenges of point-of-care testing in clinical application. Chin J Lab Med 2019;42:323–7. (Chinese).

3. ISO. In vitro diagnostic test systems-requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus [S/OL]. 2013-05-14, 2015-08-20.

4. International Organization for Standardization (ISO). ISO2287:2016(en) Point-of-care testing (POCT)-requirements for quality and competence [DB/OL]. 2021-04-01.

5. Nichols, JH, Alter, D, Chen, Y, Isbell, TS, Jacobs, E, Moore, N. AACC Guidance document on management of point-of-care testing. J Appl Lab Med 2020;5:762–87. https://doi.org/10.1093/jalm/jfaa059.

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