Investigation of the Effect of 70 Potential Interferents on Measurement Results of Two Blood Glucose Monitoring Systems
Authors' conclusion
The BGMS investigated in this study were found to be robust with respect to the 70 evaluated potential interferents. Interference effects were observed only for N-Acetyl-L-cysteine. Extensive evaluations of potential interfering factors can make an important contribution to ensure reliability of BGMS.
Study context
- Population
- Venous whole blood samples; 70 potential interferents expected to be common in people with diabetes70 potential interferents
- Comparison
- Test samples with potential interferents vs control samples, for two blood glucose (BG) monitoring systems
- Outcome
- Interference effects as normalized biases between test and control samples; acceptance within ±10 mg/dL (glucose ≤100 mg/dL) or ±10% (>100 mg/dL)
Methodological detailspaired-difference approach based on ISO 15197:2013 and CLSI guideline EP07, three reagent system lots per system, venous whole blood samples at two glucose concentrations
- Paired-difference approach based on ISO 15197:2013 and CLSI guideline EP07
- Three reagent system lots per system
- Venous whole blood samples at two glucose concentrations
Recommendations
As reported in the abstract
Normalized bias within predefined acceptance criteria
Potential interferents for which both systems met acceptance criteria, for each of the three reagent system lots
69 of 70
Original publication
Investigation of the Effect of 70 Potential Interferents on Measurement Results of Two Blood Glucose Monitoring Systems. J Diabetes Sci Technol. Published 15 February 2024. doi:10.
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