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Comment
. 2012 Sep 1;6(5):1182-4.
doi: 10.1177/193229681200600523.

Interference testing: why following standards is not always the right thing to do

Jan S Krouwer  1
Affiliations
Comment

Interference testing: why following standards is not always the right thing to do

Jan S Krouwer. J Diabetes Sci Technol. .

Abstract

Lucarelli and colleagues in this issue of Journal of Diabetes Science and Technology describe the results of interference testing for a continuous glucose monitoring system. The authors follow the Clinical Laboratory Standards Institute guideline EP7-A2, including their conclusions, in which the concepts of a statistically significant interfering substance and a clinically important interference have been combined in a way whereby information from the experiment has been lost and could be misleading. A better way to treat the data is presented, including a simulation method to evaluate the effects of interferences.

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Figures

Figure 1
Figure 1
Average percentage difference (middle point) and 95% upper and lower confidence interval for test minus control for various hypothetical candidate interfering substances. The goal for clinical acceptability of this difference in this example is ±10%. Note, a similar figure appeared in the CLSI guideline EP7-P but is not in later versions of the guideline.
See this image and copyright information in PMC

Comment on

References

    1. Lucarelli F, Ricci F, Caprio F, Valgimigli F, Scuffi C, Moscone D, Palleschi G. GlucoMen Day continuous glucose monitoring system: a screening for enzymatic and electrochemical interferents. J Diabetes Sci Technol. 2012;6(5):1172–1181. - PMC - PubMed
    1. Clinical and Laboratory Standards Institute. Interference testing in clinical chemistry; approved guideline—second edition. CLSI document EP7-A2. Wayne: Clinical and Laboratory Standards Institute; 2005.

MeSH terms