Point-of-Care Blood Glucose Testing: Post-Market Performance Assessment of the Accu-Chek Inform II Hospital-Use Glucose Meter

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Abstract

Background. A point-of-care glucose testing (POCT) is an essential component of care in patients with hyperglycemia and hypoglycemia in inpatient and outpatient settings. In Russian medical facilities (MFs), conventional glucose meters designed for self-monitoring by patients with diabetes are commonly used for POCT. These home-use meters have two serious disadvantages: the first is large measurement bias and the second – they can’t be integrated into laboratory information systems, so measurement data have to be recorded into patient charts manually. Both factors may lead to medical errors. It is reasonable to use in the MFs specialized POCT glucose meters, as they are superior to conventional ones in accuracy and may be easily connected to laboratory information systems. With this in mind, physicians at the Russian Children’s Clinical Hospital decided to substitute conventional meters with the Accu-Chek Inform II POCT meter, however, after preliminary performance assessment of the model.

Aim. To test the Accu-Chek Inform II performance characteristics: accuracy, linearity, repeatability, and mean absolute relative difference (MARD).

Materials and methods. Performance of the Accu-Chek Inform II was tested by comparing the results of parallel CGL measurements with the meter and reference laboratory analyzer in capillary blood samples. Overall, 99 parallel CGL measurements were made in 45 samples. Accuracy was evaluated according to the ISO 15197-2013 and POCT12-A3 criteria.

Results. The Accu-Chek Inform II meter met the requirements of ISO 15197-2013 and POCT12-A3 and demonstrated high linearity (correlation coefficient, r=1,0), good repeatability (mean coefficient of variation, CV=1,38%) and acceptable MARD (4,9%).

Conclusion. The Accu-Chek Inform II POCT glucose meter may be efficiently and safely used in inpatient and outpatient MFs and particularly in pediatric clinics.

About the authors

Elena E. Petryaykina

Russian Children’s Clinical Hospital – Branch of Pirogov Russian National Research Medical University

Email: alvaltim@gmail.com
ORCID iD: 0000-0002-8520-2378

дир.

Russian Federation, Moscow

Nikolay A. Mayanskiy

Russian Children’s Clinical Hospital – Branch of Pirogov Russian National Research Medical University

Email: alvaltim@gmail.com
ORCID iD: 0000-0001-8077-5313

рук. Центра лабораторной диагностики

Russian Federation, Moscow

Elena S. Demina

Russian Children’s Clinical Hospital – Branch of Pirogov Russian National Research Medical University

Email: alvaltim@gmail.com
ORCID iD: 0000-0002-4396-1245

зав. эндокринологическим отд-нием

Russian Federation, Moscow

Irina V. Karamysheva

Russian Children’s Clinical Hospital – Branch of Pirogov Russian National Research Medical University

Email: alvaltim@gmail.com

врач клинической лабораторной диагностики Центра лабораторной диагностики

Russian Federation, Moscow

Kseniya A. Gorst

Russian Children’s Clinical Hospital – Branch of Pirogov Russian National Research Medical University

Email: alvaltim@gmail.com
ORCID iD: 0000-0002-5986-4976

врач клинической лабораторной диагностики Центра лабораторной диагностики

Russian Federation, Moscow

Alexei V. Timofeev

Russian Children’s Clinical Hospital – Branch of Pirogov Russian National Research Medical University

Author for correspondence.
Email: alvaltim@gmail.com
ORCID iD: 0000-0002-6861-9630

врач клинической лабораторной диагностики Центра лабораторной диагностики

Russian Federation, Moscow

References

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Supplementary files

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2. Fig. 1. Bland–Altman plot for blood glucose meter X. In 440 blood samples, CGL was measured simultaneously using a blood glucose meter and a reference analyzer. For each pair of measurements, the deviation of the glucose meter result from the analyzer result (triangles) was calculated. Solid lines are the limits of permissible deviations according to GOST 15197. The dotted line is a hypothetical line of zero deviations (a perfect match of all glucose meter results with all corresponding analyzer results).

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3. Fig. 2. CEG plot for blood glucose meter X. The results of 400 measurements of CGL using a glucose meter are plotted on the CEG plot. Each glucose meter result is compared with the result of the reference analyzer. The plot shows 5 zones with different risk degrees.

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4. Fig. 3. Demonstration of SEG plot on the SEG Software website [10]. The results of 600 measurements of CGL using a glucose meter are plotted on the SEG plot. Each glucose meter result is compared with the analyzer result. The plot shows 5 zones with different risk degrees. Green = zero risk, yellow = negligible risk, orange = moderate risk, red = high risk, brown = very high risk.

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5. Fig. 4. Assessment of the Accu-Chek Inform II glucose meter analytical accuracy compliance with the ISO 15197. The dotted line is a line of the perfect match between the results of the Accu-Chek Inform II glucose meter and the analyzer. Thin solid lines are the limits of the range of permissible deviations according to ISO 15197. The arrow indicates an out-of-range result. The X-axis is CGL measured by the analyzer, mmol/L. The Y-axis is a difference between CGL measured by the Inform glucose meter and analyzer, mmol/L.

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6. Fig. 5. Assessment of the Accu-Chek Inform II glucose meter clinical accuracy compliance with the ISO 15197. The dotted line is a line of the perfect match between the results of the Accu-Chek Inform II glucose meter and the analyzer. Solid lines are the boundaries of the risk zones. The X-axis is CGL measured by the analyzer, mmol/L. The Y-axis is CGL measured by the Accu-Chek Inform II glucose meter, mmol/L.

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7. Fig. 6. Assessment of the Accu-Chek Inform II glucose meter clinical accuracy according to the SEG plot.

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8. Fig 7. Assessment of the Accu-Chek Inform II analytical accuracy compliance with the POCT12-A3. The dotted line is a line of the perfect match between the results of the Accu-Chek Inform II glucose meter and the analyzer. Black lines are the limits of the range of permissible deviations according to the POCT12-A3 first requirement. Grey lines are the limits of the range of permissible deviations according to the POCT12-A3 second requirement. The arrows indicate out-of-range results. The X-axis is CGL measured by the analyzer, mmol/L; the Y-axis is the difference between CGL measured by the Accu-Chek Inform II glucose meter and the analyzer, mmol/L.

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9. Fig. 8. Assessment of the linearity of the Accu-Chek Inform II glucose meter. The solid line is a regression curve. The dotted line is a line of the perfect match between the results of the Accu-Chek Inform II and the analyzer. In the top of the figure, the regression equation is written, where r – correlation coefficient; КС – shift factor; КН – slope coefficient. The X-axis is CGL measured by the analyzer, mmol/L; the Y-axis is CGL measured by the Accu-Chek Inform II, mmol/L.

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10. Appendix_A

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11. Appendix_2

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12. Appendix_3

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13. Appendix_4

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14. Appendix_5

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