A lack of quality control tools limits the enforcement of fortification policies. In alignment with the World Health Organization’s ASSURED criteria (affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free, and deliverable), a paper-based assay that interfaces with a smartphone application for the quantification of iron fortificants is presented. The assay is based on the Ferrozine colorimetric method. The reaction started after deposition of the 5 µL aqueous sample and drying. After developing color, pixel intensity values were obtained using a smartphone camera and image processing software or a mobile application, Nu3px. From these values, the actual iron concentration from ferrous sulfate and ferrous fumarate was calculated. The limits of detection, quantification, linearity, range, and errors (systematic and random) were ascertained. The paper-based values from real samples (wheat flour, nixtamalized corn flour, and infant formula) were compared against atomic emission spectroscopy. The comparison of several concentrations of atomic iron between the spectrophotometric and paper-based assays showed a strong positive linear correlation (y = 47.01x + 126.18; R2 = 0.9932). The dynamic range (5.0–100 µg/mL) and limit of detection (3.691 µg/mL) of the paper-based assay are relevant for fortified food matrices. Random and systematic errors were 15.9% and + 8.65 µg/g food, respectively. The concept can be applied to limited-resource settings to measure iron in fortified foods.

Iron fortification of staple foods is a common practice around the world to reduce the prevalence of iron-deficiency anemia. More recently, fortified condiments, including salts, sauces, and powders, have been tested in various efficacy trials. However, there is limited information on how nutritional, environmental, and experimental factors affect their efficacy and effectiveness. The purpose of the present work was to systematically review performance factors affecting the efficacy of condiment fortification trials. Three databases were searched using a standardized keyword search and included based on four-point inclusion criteria. Studies were evaluated against a quality assessment tool and effect sizes were calculated. Studies were ranked as low or high performing, based on whether or not they significantly improved iron-deficiency outcomes (hemoglobin, anemia prevalence, and ferritin levels). Of the 955 retrieved studies, 23 were included—of which, nine performed poorly, eight performed highly, and six were classified as neither because they did not meet the criteria of assessing the three iron outcomes. Results showed that unsuccessful trials did not consider environmental factors such as parasitic infections, nutritional factors such as micronutrient deficiencies other than iron, consumer acceptability of the product or experimental factors such as monitoring and adherence to the trials. Two common performing factors identified among those studies performing highly vs. those that did not were the control of sensory changes and monitoring of consumption compliance (i.e., dose delivery). The present work can be used as decision-making support for nutrition policy makers when determining the appropriate implementation of condiment fortification programs.

In resource-limited settings, mass food fortification is a common strategy to ensure the population consumes appropriate quantities of essential micronutrients. Food and government organizations in these settings, however, lack tools to monitor the quality and compliance of fortified products and their efficacy to enhance nutrient status. The World Health Organization has developed general guidelines known as ASSURED (Affordable, Sensitive, Specific, User-friendly, Rapid and Robust, Equipment-free, and Deliverable to end-users) to aid the development of useful diagnostic tools for these settings. These guidelines assume performance aspects such as sufficient accuracy, reliability, and validity. The purpose of this systematic narrative review is to examine the micronutrient sensor literature on its adherence towards the ASSURED criteria along with accuracy, reliability, and validation when developing micronutrient sensors for resource-limited settings. Keyword searches were conducted in three databases: Web of Science, PubMed, and Scopus and were based on 6-point inclusion criteria. A 16-question quality assessment tool was developed to determine the adherence towards quality and performance criteria. Of the 2,365 retrieved studies, 42 sensors were included based on inclusion/exclusion criteria. Results showed that improvements to the current sensor design are necessary, especially their affordability, user-friendliness, robustness, equipment-free, and deliverability within the ASSURED criteria, and accuracy and validity of the additional criteria to be useful in resource-limited settings. Although it requires further validation, the 16-question quality assessment tool can be used as a guide in the development of sensors for resource-limited settings.

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 μg Fe/g flour; reject < 40 μg 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 μg 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.

Background: In Mexico, the fortification of corn and wheat flours with iron, zinc, and folic acid and the restoration of B-vitamins is a mandatory program. However, the monitoring and evaluation (M&E) of this fortification process is not well understood. Thus, the purpose of the study was to understand the M&E of the food fortification program in Mexico, with an emphasis on technology research and development. Methods: Open-ended exploratory interviews were conducted with food technology representatives (n = 9), food science academic faculty (n = 1), president of a private tortilla-making federation (n = 1), and representatives of the federal monitoring agency (n = 2). Interviews were transcribed and themes were identified using the content analysis methodology. Inter-rater reliability was assessed by calculating an intraclass correlation coefficient (ICC) between the raters (n = 3). Results: A total of 49 codes were identified that resulted in three overarching themes, manufacturing/processing, monitoring logistics, and nutrition. Overall, there is a need for more robust internal and external M&E with Mexico’s fortification program to improve the manufacturing/processing of fortifying the tortillas, the monitoring of this fortification program, and the impact the fortified tortillas have on the nutritional status of the Mexican population. The overall ICC was 0.87. Conclusions: The present study can be used to gain insight into Mexico’s fortification program and to inform food fortification policymakers of best practices.