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A step-wise, 'test-all-positive-gluten' analytical methodology has been developed and verified to assess kernel-based gluten contamination (i.e., wheat, barley and rye kernels) during gluten-free (GF) oat production. It targets GF claim compliance at the serving-size level (of a pouch or approximately 40-50g). Oat groats are collected from GF oat production following a robust attribute-based sampling plan then split into 75-g subsamples, and ground. R-Biopharm R5 sandwich ELISA R7001 is used for analysis of all the first15-g portions of the ground sample. A >20-ppm result disqualifies the production lot, while a >5 to <20-ppm result triggers complete analysis of the remaining 60-g of ground sample, analyzed in 15-g portions. If all five 15-g test results are <20ppm, and their average is <10.67ppm (since a 20-ppm contaminant in 40g of oats would dilute to 10.67ppm in 75-g), the lot is passed.

Oats are often contaminated with rogue kernels of gluten-containing grains like wheat, barley and rye. When producing gluten free oatmeal, possessing an understanding of the consequences of this possibility is prudent, as labeling requirements specify a maximum amount of gluten in terms of 'parts per million' (ppm) gluten. Variation in contaminant kernels, along with variation due to measurement itself though, can result in a wide range of possible ppm gluten outcomes in contaminated servings. This research pursues characterization of this variability, highlighting contributors to it, doing so by quantifying distributional outcomes of ppm gluten in wheat kernel contaminated servings. This is done via statistical simulation of wheat kernel contaminated servings, done for a collection of wheat types and incorporating various measurement influences. Results indicate substantial variability in ppm gluten per serving for a given wheat type, as well as between them, with this being compounded by the measurement task itself.

SummaryGluten-free (GF) foods, whose claim compliance is controlled at the 'serving level', hold better chances of protecting gluten-intolerant consumers. This is particularly true for GF oatmeal, as oats are easily contaminated with gluten-rich kernels of wheat, rye and barley, which remain intact to the spoon as pill-like flakes. A single contaminant kernel in otherwise pure oats results in GF labelling noncompliance, thereby posing a risk to patients with coeliac disease. Our in-market survey of 965 GF oatmeal servings uncovered that one in fifty-seven servings exceeded the GF labelling maximum of 20 mg kg À1 (i.e. 20 ppm). The noncompliance pattern was 'binary-like', with kernel-based contamination the suspected pass/fail driver.We have highlighted probabilities of misassessment for various sample sizes in light of oat's natural propensity for kernel-based contamination and proposed use of attribute-based sampling for compliance assessment, thereby providing a way to assess/manage/control 'rates of servings containing a contaminant kernel' within acceptable limits with high confidence.Keywords Acceptance sampling, binomial, coeliac disease, ELISA, gluten, gluten-free, inference, in-market survey, oat. IntroductionCoeliac disease (CD) is a lifelong, genetic, autoimmune intestinal disorder that affects approximately 0.2-1.0% of the world population (Sanders et al., 2003;Catassi & Fasano, 2008;Mustalahti et al., 2010;Ludvigsson et al., 2013;Mooney et al., 2016). Patients with CD have to abstain from dietary intake of gluten proteins found in wheat, barley and rye, as these proteins trigger autoimmune destruction of the mucosa of the small intestine (Janatuinen et al., 1995). Members of a household that includes a patient with CD often choose to follow a GF diet as well, to avoid accidental consumption of gluten-containing food by the patient with CD. Increased numbers of consumers are also choosing to follow a GF diet (Sharma et al., 2015). As a consequence, GF food products are getting more popular in the marketplace (Sapone et al., 2012). To protect this growing number of consumers, food regulatory agencies have started to regulate gluten content in products with GF claims. For example, the US Food and Drug Administration (FDA) has decided that foods with GF claims should contain less than 20 ppm (i.e. mg kg À1 ) of gluten (Sharma et al., 2015). This has elevated the need for improved methodologies to determine whether grain-based product meets this standard. Oats are recognised as one of the most important whole grain foods, being rich in dietary fibre, B-complex vitamins (thiamin, niacin and riboflavin), iron and proteins (Comino et al., 2015;Rebello et al., 2016). To expand the dietary options of patients with CD, as well as those following a GF diet, many researchers have investigated the suitability of dietary inclusion of oats (Lundin et al., 2003;Thompson, 2003;Comino et al., 2011Comino et al., , 2015Londono et al., 2013;Tapsas et al., 2014). Although there has been debate whether oats present risks to...

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Oats are naturally gluten-free, but are commonly contaminated with gluten-containing kernels of wheat, barley, and rye. Gluten compliance (FDA, gluten <20 ppm) when managed at the serving level (40-50 g) is believed to provide the best protection to consumers. In this recent in-market survey, a third-party laboratory tested 166 servings of oatmeal manufactured with oats produced under a "Purity Protocol." Results indicated gluten at noncompliant levels in five servings (spanning 20.4-229 ppm). This equates to a noncompliance rate of 1 in 33 servings. This new finding is comparable to a noncompliant rate of 1 in 57 servings uncovered by our previous in-market survey, where the gluten-free (GF) oatmeal was manufactured with oats produced by mechanical/optical cleaning. These new findings, substantiated by the previous ones, show that GF oats not managed for gluten compliance at the serving level may introduce an intermittent bolus of gluten to consumers with celiac disease.

Vitamin D deficiency is widespread globally, however available data for the Russian adult population is fragmented. This cross-sectional study used secondary data for individuals undergoing testing for vitamin D concentrations from 2013 to 2018 by InVitro laboratory. 25(OH)D serum concentration was determined using chemiluminescent microparticle immunoassay. The mean, median, and proportion with severe, deficient, insufficient and sufficient 25-hydroxyvitamin D (25(OH)D) concentrations were estimated. Splines examined the effect of latitude on 25(OH)D concentrations. Data were available for 30,040 subjects age ≥ 18 years. 24.2% of the sampled population had sufficient (30–< 150 25(OH)D ng/mL), 34% deficient (10–19.9 ng/mL) and 5.6% severely deficient (< 10 ng/mL) status. Average 25(OH)D concentrations were highest among 30–44 years and lowest amongst older adults; females had modestly higher values. Concentrations were 15% higher in fall/summer vs. winter/spring. A non-linear relationship was observed by latitude; the highest 25(OH)D concentrations were observed near 54°N, decreasing at more southern latitudes for women and more northern latitudes for both sexes. These results are comparable to other Northern European publications and limited Russian samples demonstrating low concentrations. Acknowledging that nationally-representative and randomly sampled data are needed, the present data suggest the burden may be high and identifies some population sub-groups and geographic areas with a higher potential deficiency of vitamin D.