In-Country Method Validation of a Paper-Based, Smartphone-Assisted Iron Sensor for Corn Flour Fortification Programs

Food fortification in low-income settings is limited due to the lack of simple quality control sensing tools. In this study, we field validated a paper-based, smartphone-assisted colorimetric assay (Nu3Px) for the determination of iron in fortified flours against the gold standard method, atomic emission spectrometry (AES). Samples from commercial brands (n = 6) were collected from supermarkets, convenience stores, and directly from companies in Mexico and characterized using both Nu3Px and AES. Nu3Px's final error parameters were quantified (n = 45) via method validation final experiments (replication and comparison of methods experiment). Qualitative pilot testing was conducted, assessing Nu3Px's accept/reject batch decision making (accept >= 40 mu g Fe/g flour; reject < 40 mu g Fe/g flour) against Mexico's fortification policy. A modified user-centered design process was followed to develop and evaluate an alternative sampling procedure using affordable tools. Variation of iron content in Mexican corn flours ranged from 23% to 39%. Nu3Px's random error was 12%, and its bias was 1.79 +/- 9.99 mu g Fe/g flour. Nu3Px had a true mean difference from AES equal to 0 and similar variances. AES and Nu3Px made similar classifications based on Mexico's policy. Using simple, affordable tools for sampling resulted in similar output to the traditional sampling preparation (r = 0.952, p = 0.01). The affordable sample preparation kit has similar precision to using analytical tools. The sample preparation kit coupled with the smartphone app and paper-based assay measure iron within the performance parameters required for the application to corn flour fortification programs, such as in the case of Mexico.

Automated summary

This study validated a paper-based, smartphone-assisted colorimetric assay (Nu3Px) for determining the iron content in fortified flours compared to the gold standard method, atomic emission spectrometry (AES). The results showed that Nu3Px had good error parameters and similar classifications to AES, and using affordable sampling tools also yielded accurate results.