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Food
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Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food. Appendices
Appendices
| Allergen | Manufacturera | Method | Validationb | Sensitivity (LODc) (ppm) | Quantitation (LOQc) (ppm) | Raw and Processed Foods? | Species Specificity | Protein(s) Detected | Practicality |
|---|---|---|---|---|---|---|---|---|---|
| Peanut | Abkem Iberia | Peanut DiagnoKit | No | Not reported | Not reported | Yes (for specified foods) | Not reported | Not reported | Yes |
| Elisa Systems | Peanut | JRC | 0.5 | 1 | Yes | Peanut | Ara h2 | Yes | |
| Elisa Systems | Total Peanut | No | 0.5 | 1 | Yes | Peanut | Total | ||
| Neogen | Alert for Peanut | No | 5 | No | Not reported | Not reported | Not reported | Yes | |
| Neogen | Reveal for Peanut | No | 5 | No | Not reported | Not reported | Not reported | Yes | |
| Neogen | Veratox for Peanut | AOAC MLPT | Not reported | 2.5 | Yes (for specified foods) | Peanut | Not reported | Yes | |
| R-BioPharm | RiDASCREEN Peanut | No | 2.5 | Not reported | Yes | Not reported | Total | Yes | |
| R-BioPharm | RIDASCREEN FAST Peanut | AOAC MLPT | 1.5 | 2.5 | Yes (for specified foods) | Peanut | Total | Yes | |
| Tecra | Peanut Visual Immunoassay | No | 0.5 | 2.5 | Yes | Not reported | Not reported | Yes | |
| Tepnel | BioKits Peanut | AOAC MLPT | 0.1 | 1 | Yes (for specified foods) | Peanut | Conarachin (Ara h 1) | Yes | |
| Tepnel | BioKits Rapid Peanut | No | Not reported | No | Not reported | Not reported | Not reported | Yes | |
| Milk |
Abkem Iberia | Casein DiagnoKit | No | Not reported | 0.16 | Yes (for specified foods) | Not reported | Casein | Yes |
| Elisa Systems | Beta-lactoglobulin | No | 0.5 | 1 | Yes | Not reported | Beta- Lactoglobulin | Yes | |
| Elisa System | Enhanced Beta-lactoglobulin | No | 1 | 1 | Yes | Not reported | Beta-Lactoglobulin | Yes | |
| Elisa Systems | Enhanced Casein | No | 1 | 1 | Yes | Not reported | Casein | Yes | |
| Neogen | Alert for Total Milk | No | 5 whole milk10 dry nonfat milk | No | Yes | Not reported | Not reported | Yes | |
| Neogen | Veratox for Total Milk | No | Not reported | 2.5 | Yes (for specified foods) | Not reported | Not reported | Yes | |
| R-BioPharm | RIDASCREEN Beta-Lactoglobulin | No | 0.2 | 5 | Not reported | Not reported | Beta- Lactoglobulin | Yes | |
| SafePath | Milk Residue | No | Not reported | Not reported | Not reported | Not reported | Beta- Lactoglobulin | Yes | |
| Tepnel | BioKits BLG | No | 7.5 | 25 | Yes | Not reported | Primarily Beta-Lactoglobulin | Yes | |
| Tepnel | BioKits BSA | No | 10 | 25 | Yes | Not reported | Bovine Serum Albumin | Yes | |
| Tepnel | BioKits Casein | No | 1 | 2 | Yes | Not reported | Primarily Alpha-Casein | Yes | |
| Tepnel | BioKits Casein Rapid | No | Not reported | Not reported | Yes (for specified foods) | Not reported | Casein | Yes | |
| Egg | Elisa Systems | Egg | No | 0.5 | 1 | Yes | Ovalbumin, Ovamucoid | Yes | Not reported |
| Neogen | Alert for Egg | No | 5 | N | Yes (for specified foods) | Not reported | Not reported | Yes | |
| Neogen | Veratox for Egg | No | Not reported | 2.5 | Yes (for specified foods) | Not reported | Not reported | Yes | |
| R-BioPharn | RIDASCREEN Egg Protein | No | 2 | Not reported | Yes (for specified foods) | Not reported | White | Yes | |
| SafePath | Egg Residue | No | Not reported | Not reported | Not reported | Not reported | Ovomucoid | Yes | |
| Tecra | Egg Visual Immunoassay | No | 0.5 | 0.6 | Yes | Total | Yes | ||
| Tepnel | BioKits Egg | No | 0.1 | 0.5 | Yes | Not reported | Ovomucoid | Yes | |
| Tree Nuts | Abkem Iberia | Almond DiagnoKit | No | Not reported | 0.06 | Not reported | Not reported | Not reported | Yes |
| Abkem Iberia | Hazelnut DiagnoKit | No | Not reported | 0.08 | Not reported | Not reported | Not reported | Yes | |
| Elisa System | Almond | No | 0.5 | 1 | Yes | Not reported | Not reported | Yes | |
| Elisa System | Hazelnut | No | 0.25 | 0.5 | Yes | Not reported | Not reported | Yes | |
| Neogen | Alert for Almond | No | 5 | No | Not reported | Not reported | Not reported | Yes | |
| Neogen | Veratox for Almond | No | Not reported | 2.5 | Not reported | Not reported | Not reported | Yes | |
| R-BioPharm | RIDASCREEN Hazelnut | No | 3.3 | Not reported | Not reported | Not reported | Total | Yes | |
| R-BioPharm | RIDASCREEN FAST Almond | No | 1.7 | 2.5 | Not reported | Not reported | Total | Yes | |
| Soy | Elisa System | Soy | No | 1 | 1 | Yes (for specified foods) | Not reported | Trypsin Inhibitor | Yes |
| Elisa Systems | Enhanced Soy | No | 1 | 2.5 | Yes (for specified foods) | Not reported | Soy flour proteins | Yes | |
| SafePath | Soy Residues | No | Not reported | Not reported | Not reported | Not reported | Trypsin Inhibitor | Not reported | |
| Neogen | Alert for Soy Flour | No | 5 | Not reported | Yes | Not reported | Not reported | Yes | |
| Neogen | Veratox for Soy Flour | No | 2.5 | 2.5 | Yes | Not reported | Not reported | Yes | |
| Tepnel | Soya Protein | No | 0.5% soy protein in food sample | 0.5% soy protein in food sample | Not reported | Not reported | Not reported | Yes | |
| Crustaceans | Abkem Iberia | Crustacean DiagnoKit | No | Not reported | 0.005 | Not reported | shrimp, crab, lobster and scampi. | Tropomyosin | Yes |
| Elisa Systems | Crustacean (18 species) | No | 0.05 | 0.05 | Yes (for specified foods) | Not reported | Tropomyosin | Yes | |
| Fish | No commercial methods are available. | ||||||||
| Wheat | See Appendix 4 for gluten methods. No other commercial methods are available. |
a Information from manufacturers web sites, except for information on the Elisa System Crustacean test kit from FDA Docket #2005N-0231, comment number EC1.
bMLPT - Multiple Laboratory Performance Tested; JRC- European Commission Joint Research Centre; AOAC = AOAC International.
cLOD = Limit of detection, LOQ = Limit of quantiation.
| Study | Published | Test Population | Food Allergen Tested | Test Material | Lowest Dose Tested (mg proteina) | Dose Progression | Responses at lowest dose tested? | LOAEL Observed (mg proteina, b) | Sign(s)s or symptom(s) used to determine LOAEL | Population Dose/Response Data |
|---|---|---|---|---|---|---|---|---|---|---|
| May, 1976 | Yes | 38 asthmatic children, 8 reacted to peanut, 1 to milk, 4 t o egg | Peanut, | Raw peanut | 25 | 2-10 fold increase | Yes | 25 | Objective | Not reported |
| Milk | Whole | Not reported | 2-10 fold increase | No | Not reported | Objective | Not reported | |||
| Egg | Whole | Not reported | 2-10 fold increase | No | Not reported | Objective | Not reported | |||
| Eggs | Dried | Not reported | 2-10 fold increase | No | 250 | Objective | Not reported | |||
| Bock et al., 1978 | Yes | 68 children with suspected allergy, 12 reacted to peanut, 10 to milk, 10 to egg, 5 to soy, 2 to cashew, 1 each to pecan, filbert, pistachio | Peanut | Unroasted | Not reported | Not reported | Not reported | 25 | Objective | No |
| Milk | Dried nonfat | Not reported | Not reported | Not reported | 280 | Objective | No | |||
| Egg | Dried whole | Not reported | Not reported | Not reported | 1 | Objective | No | |||
| Soy | Protein isolate | Not reported | Not reported | Not reported | Not reported | Objective | No | |||
| Cashew | Not reported | Not reported | Not reported | Not reported | Not reported | Objective | No | |||
| Pecan | Not reported | Not reported | Not reported | Not reported | Not reported | Objective | No | |||
| Filbert | Not reported | Not reported | Not reported | Not reported | Not reported | Objective | No | |||
| Cashew | Not reported | Not reported | Not reported | Not reported | Not reported | Objective | No | |||
| Pistaschio | Not reported | Not reported | Not reported | Not reported | Not reported | Objective | No | |||
| Pasterello et al., 1989 | Yes | 23 adults with suspected allergy, 4 reacted t milk, 2 to hazelnut, and 1 each to egg and wheat | Milk | Dried | Not clear - differed for different foods | Dose doubling | Not reported | 187 | Objective | No |
| Egg white | Dried | No | 1500 | Objective | No | |||||
| Hazelnut | Ground | No | 2775 | Objective | No | |||||
| Bernhisel-Broadbent et al., 1992b | Yes | 11 fish allergic children and adults | Fish | Raw and cooked extracts of 9 species | Not reported | Not reported | Not reported | Not reported | Not reported | No |
| Caffarelli et al., 1995 | Yes | 21 infants and children with no previous egg exposure, 14 reacted | Egg | Dried egg | 0.042 | Not reported | No | 0.42 | Objective | No |
| Magnolfi et al., 1996 | Yes | 131 skin prick positive children, 8 reacted | Soy | Formula | "1 drop" for infants | 6 defined doses | No | 360 | Objective | No |
| 88 mg soy protein for older children | 7 defined doses | Yes | 88 | Objective | No | |||||
| Hourihane et al., 1997a | Yes | 14 peanut allergic adults, 8 reacted | Peanut | Peanut flour | 0.01 | 12 defined doses | No |
0.1 2 |
Subjective Objective |
Yes |
| Hourihane et al., 1997b | Yes | 60 peanut allergic adults | Peanut | Whole peanut | ? (Labial challenge) | 4 defined doses | Yes | Not reported | Objective | No |
| Nelson et al., 1997 | Yes | 12 peanut allergic adults | Peanut | Defatted peanut | 0.45 | 12 defined doses | Not reported | Not reported | Subjective | No |
| Bellioni-Businco et al., 1999 | Yes | 26 milk allergic children | Milk | "Fresh" whole milk | "1 drop" | Not reported | 3.65 | Objective | No | |
| Hebling et al., 1999 | Yes | 9 fish allergic adults | Fish | Cooked meat from 3 species of fish | 50 | 4 specified levels | Yes | 50 | Subjective and Objective | Yes |
| Zeiger et al., 1999 | Yes | 93 milk allergic infants and children, 13 reacted to soy | Soy | Formula | 1 drop to 5 ml | 6 to 7 doublings | No | 522 | Objective | No |
| Otolani et al., 2000 | Yes | 86 hazelnut allergic adults | Hazelnut | Ground nuts | 224 | Dose doubling, possibly 4 levels | Not reported | Not reported | Not reported | No |
| Sicherer et al., 2000 | Yes | 196 children with a variety of food allergiesc | Peanut | Not reported | 400 or 500 mg of food | 6 or 7 specified levels | Yes | Not reported | Not reported | No |
| Milk | Not reported | Not reported | Not reported | No | ||||||
| Egg | Not reported | Not reported | Not reported | No | ||||||
| Soy | Not reported | Not reported | Not reported | No | ||||||
| Fish | Not reported | Not reported | Not reported | No | ||||||
| Wheat | Not reported | Not reported | Not reported | No | ||||||
| Eggesbo et al., 2001 | Yes | 41 children with reported allergy, 5 tested by DBPCFC | Egg | Pancakes | 260 | Dose doubling until reaction or maximum dose | Yes | 260 | Objective | No |
| Bindslev-Jensen and Hansen in Taylor et al., 2002 | No | 14 patients, not clear whether all were challenged with each fish | Fish | Cod | Not reported | Not reported | 5 mg of fish | |||
| Mackerel | Not reported | Not reported | Not reported | 500mg of fish | ||||||
| Herring | Not reported | Not reported | Not reported | 5mg of fish | ||||||
| Plaice | Not reported | Not reported | Not reported | 6000mg of fish | ||||||
| Bindslev-Jensen and Mortz in Taylor et al., 2002 | No | 5 patients | Peanut | Ground | Not reported | Not reported | Not reported | 40 | Not reported | No |
| Bindslev-Jensen and Norgaard in Taylor et al., 2002 | No | 3 milk allergic, 7 egg allergic patients | Milk | Whole | Not reported | Not reported | Not reported | 180 | Not reported | No |
| Egg | Whole raw | Not reported | Not reported | Not reported | 0.65 | Not reported | No | |||
| Bock in Taylor et al., 2002 | No | 69 peanut allergic, 66 milk allergic, 91 egg allergic, 8 fish allergic patients | Peanut | Ground | Not reported | Not reported | Not reported | 1.25 | Not reported | No |
| Milk | Nonfat dried | Not reported | Not reported | Not reported | 67 | Not reported | No | |||
| Egg | Whole or dried | Not reported | Not reported | Not reported | Not reported | Not reported | No | |||
| Fish | Minced | Not reported | Not reported | Not reported | 200 mg of fish | Not reported | No | |||
| Burks and Christie in Taylor et al., 2002 | No | 10 peanut allergic, 21 milk allergic, 25 egg allergic patients | Peanut | Peanut butter | Not reported | Not reported | Not reported | 100 | Not reported | No |
| Milk | Nonfat dried | Not reported | Not reported | Not reported | 140 | Not reported | No | |||
| Egg | Whole dried | Not reported | Not reported | Not reported | 200 | Not reported | No | |||
| Hill in Taylor et al., 2002 | No | 100 patients each for peanut, milk, egg | Peanut | Peanut butter | Not reported | Not reported | Not reported | 6 | Not reported | No |
| Milk | Whole | Not reported | Not reported | Not reported | 0.6 | Not reported | No | |||
| Egg | Raw white | Not reported | Not reported | Not reported | 2 | Not reported | No | |||
| Host in Taylor et al., 2002 | No | 15 milk allergic patients | Milk | Forumula | Not reported | Not reported | Not reported | 75 | Not reported | No |
| Lack in Taylor et al., 2002 | No | 6 peanut, 6 milk, 18 egg allergic patients | Peanut | Ground | Not reported | Not reported | Not reported | 125 | Not reported | No |
| Milk | Whole | Not reported | Not reported | Not reported | 150 | Not reported | No | |||
| Egg | Cooked white | Not reported | Not reported | Not reported | 10 | Not reported | No | |||
| Raw white | Not reported | Not reported | Not reported | 20 | Not reported | No | ||||
| Moneret-Vautrin #1 in Taylor et al., 2002 | No | 28 peanut allergic, 6 milk allergic, 19 egg allergic, 4 fish allergic patients | Peanut | Ground | Not reported | Not reported | Not reported | 1.25 (single blind)2.5 (double blind) | Not reported | No |
| Milk | Whole | Not reported | Not reported | Not reported | 30 (double blind)150 (single blind)0.2 | Not reported | No | |||
| Egg | White | Not reported | Not reported | Not reported | 15mg of fish (single blind) | Not reported | No | |||
| Fish | Minced | Not reported | Not reported | Not reported | 65mg of fish (double blind) | Not reported | No | |||
| Moneret-Vautrin #2 in Taylor et al., 2002 | No | 9 peanut allergic, 8 egg allergic patients | Peanut | Ground | Not reported | Not reported | Not reported | 66 | Not reported | No |
| Egg | White | Not reported | Not reported | Not reported | 26.5 | Not reported | No | |||
| "National Jewish" in Taylor et al., 2002 | No | 3 peanut allergic patients | Peanut | Ground | Not reported | Not reported | Not reported | 2 | Not reported | No |
| Rance in Taylor et al., 2002 | No | 74 peanut allergic, 31 milk allergic, 38 egg allergic, 6 fish allergic patients | Peanut | Ground | Not reported | Not reported | Not reported | 0.25 | Not reported | No |
| Milk | Whole | Not reported | Not reported | Not reported | 15 | Not reported | No | |||
| Egg | Whole raw | Not reported | Not reported | Not reported | 0.13 | Not reported | No | |||
| Fish | Minced | Not reported | Not reported | Not reported | 16mg of fish | Not reported | No | |||
| Zeiger in Taylor et al., 2002 | No | 56 milk allergic patients | Milk | Formula | Not reported | Not reported | Not reported | 1.5 | Not reported | No |
| Wensing et al., 2002a | Yes | 31 hazelnut allergic adults | Hazelnut | Raw nuts | 1 | 7 specified doses | Yes | 1 | Subjective and Objective | Yes |
| Wensing et al., 2002b | Yes | 26 peanut allergic adults | Peanut | Roasted peanut meal | 0.030 | 10 specified doses | No | 0.1 | Subjective and Objective | Yes |
| Fiocchi et al., 2003 | Yes | 18 children with allergy to both milk and soy | Milk | Whole | 43.2 | 4 specified doses | Yes | 43.2 | Objective | Yes |
| Soy | Formula | 21.8 | 21.8 | Objective | ||||||
| Hansen et al., 2003 | Yes | 17 hazelnut allergic adults | Hazelnut | Raw and roasted nuts | Not reported | Not reported | Not reported | 32 - roasted16 - raw | Oral allergy syndrome | No |
| Morisset et al., 2003 | Yes | Undefined | Peanut | Crushed | 1.25 | 5 specified levels | Yes | 1.25 | Objective | No |
| Oil | Not reported | No | Not reported | Objective | No | |||||
| Milk | Lactose free | 0.36 | Yes | 0.36 | Objective | No | ||||
| Egg | Raw white | 0.2 | Yes | 0.2 | Objective | No | ||||
| Soy | Oil | Not reported | No | Not reported | Objective | No | ||||
| Osterballe and Bindslev-Jensen, 2003 | Yes | 56 egg allergic children | Egg | Pasteurized whole egg | 2.9 | 8 specified doses | Yes | 2.9 | Objective | No |
| Perry et al., 2004 | Yes | Not reported | Milk, egg, peanut, soy, wheat | Not reported | Not reported | Not reported | Not reported | Not reported | Not reported | No |
| Scibilia et al., 2006 | Yes | 27 wheat allergic adults | Wheat | Flour, raw and cooked | 15 | 7 specified doses | Yes | 15 | Objective | Yes |
Note: Question marks (?) in the table indicate either that the information was not given or could not be determined.
a Calculated based on the following estimate protein levels: 16% in raw hazelnuts, 20% in fish meat, 3.6% in whole milk, 37.5% in dried milk, 25% in whole peanut, 45% in defatted peanut flour, 10% in egg white, 84% in dried whole egg , 26% in raw egg, 1.8% in soy formula (FAO, 1995; Wensing et al., 2002; Bindslev-Jensen et al., 2002). In studies involving fish, the amount of fish is given when there is insufficient information to calculate protein levels.
b When responses are observed at the lowest dose tested, the reported LOAEL may not represent the lowest dose at which a reaction could occur.
c It is not clear if all children were tested with all allergens.
| Oil Type | Reference a | Protein Concentration (ug/g) | Description of Oil | Published | Protein Separation Method | Protein Quantitation Method |
|---|---|---|---|---|---|---|
| Soy | Tattrie and Yaguchi, 1973 | 0.96 | Refined, deodorized |
Yes |
Chromatography | Amino Acid Analysis |
| Klurfeld and Kritchevsky, 1987 |
1.93 0.72 |
Crude "Processed" |
Yes |
Aqueous Extraction | Commercial Bradford Assay | |
| Awazuhara et al., 1998 |
0.014 0.017 0.018 0.023 0.027 0.040 |
Uncharacterized, commercial |
Yes |
Aqueous Extraction | Lowery Assay | |
| Reeves, 1999 |
0.033 0.042 0.049 0.057 0.082 0.114 0.222 |
Fully refined, commercial |
No |
Unknown | Amino Acid Analysis | |
| Paschke et al., 2001 |
0.0332 0.0353 0.0898 0.1010 0.1380 |
Refined Unrefined |
Yes |
Acetone Precipitation | Bradford Assay | |
| Errahali et al., 2002 |
0.32 1.80 |
Deodorized Cold pressed |
Yes |
Aqueous Extraction | Unknown | |
| Nordlee et al., 2002 |
0.16 - 20.8 0.043 - 6.8 0.033 - 3.1 0.021 - 0.443 |
Degummed Refined Bleached Deodorized |
No |
Aqueous Extraction | Amino Acid Analysis | |
| Peanut | Klurfeld and Kritchevsky, 1987 |
0.120 0.154 0.204 0.206 0.580 |
Processed |
Yes |
Aqueous Extraction | Bradford Assay |
| Hoffman and Collins-Williams, 1994 |
0.2 0.6 3.3 3.3 |
Cold pressed |
Yes |
Aqueous Extraction | Commercial Coomassie Dye Assay | |
| Teuber et al., 1997 |
3.0 ± 0.3 5.7 ± 1.2 10.5 ± 0.4 10.7 ± 0.8 |
Refined, bleached, deodorized Unrefined |
Yes |
Aqueous Extraction | Commercial Bradford Assay | |
| Olszewski et al., 1998 |
0.10 0.13 0.15 0.16 0.20 |
Refined, commercial |
Yes |
Aqueous Extraction | Commercial Bicinchoninic Acid (BCA) Assay | |
| Skinner and Haynes, 1998 | 187 | Crude |
No |
Aqueous Extraction | Lowery and Commercial BCA Assay | |
| 60 | Alkali refined, neutralized | |||||
| 15 | Alkali refined, neutralized, bleached | |||||
| 2.2 | Alkali refined, neutralized, bleached, deodorized | |||||
| ISEO, 1999 |
0.047 0.049 0.063 |
Fully refined, commercial |
No |
Unknown | Amino Acid Analysis | |
| 0.828 | Partially refined, commercial | |||||
| Crevel et al., 2000 b |
48 91 |
Refined, neutralized, bleached, deodorized |
No |
Aqueous Extraction | Commercial BCA Assay | |
| 220 | Crude | |||||
| Peeters et al., 2004 |
0.09 6.4 |
Crude, noncommercial |
Yes |
Unknown | ELISA (not described) | |
| 2.55 | Cold pressed | |||||
| Tree Nut | Teuber et al., 1997 (Almond) |
2.2 ± 0.7 16.7 ± 0.8 |
Refined, bleached, deodorized |
Yes |
Aqueous Extraction | Commercial Bradford Assay |
| 12.7 ± 2.8 | Blend | |||||
| 62.2 ± 2.2 | Unrefined | |||||
| Teuber et al., 1997 (Walnut) |
7.0 ± 2.5 7.0 ± 0.8 9.2 ± 3.1 |
Refined, bleached, deodorized |
Yes |
Aqueous Extraction | Commercial Bradford Assay | |
| 16.5 ± 2.4 | Unrefined | |||||
| 20.4 ± 1.8 | Blend |
Note: Protein levels too low to detect or measure were reported by Tattrie and Yaguchi (1973), Hoffman and Collins-Williams (1994), Yeung and Collins (1996), Peeters et al. (2004) for peanut oils and by Tattrie and Yaguchi (1973), Porras et al. (1985) for soy oils. These values were not included due to the lack of methodological information.
a None of the publications provide sufficient information to evaluate the overall extraction efficiency, accuracy, reproducibility, or precision of the method used. In addition, in most cases, it was not clear whether replicate samples were tested or whether replicate measurements were carried out for individual samples.
b Crevel et al. (2000) is a review paper that includes previously unpublished data. These data are given here, but are considered unpublished because the research that generated these values has not specifically been peer-reviewed.
| Method a | Validation | Sensitivity (LOD) (ppm gluten) | Quantitation (LOQ) (ppm gluten) | Raw and Baked Foods? | Species Specificity | Protein(s) Detected | Practicality |
|---|---|---|---|---|---|---|---|
| Diffchamb Transia Plate Gluten | No | 10 | Not reported | Not reported | Wheat, triticale, rye, barley | Gliadin | Yes |
| Diffchamb Transia Plate Prolamins | Working Group on Prolamin Analysis and Toxicity | 3 | Not reported | Yes | Wheat, triticale, rye, barley | Gliadin | Yes |
| Ingensa Gluten EIA | No | 3 | Not reported | Not reported | Wheat, rye, barley | Gliadin | Not reported |
| Neogen Alert for Gliadin | No | 10 | No | Not reported | Wheat, rye, barley | Gliadin | Yes |
| Neogen Veratox for Gliadin | No | 5 | 5 | Not reported | Wheat, rye, barley | Gliadin | Yes |
| R-BioPharm RIDASCREEN Gliadin | Prolamin Working Group Ring Study b | 3 | 5 | Yes | Wheat, rye, barley | Gliadin | Yes |
| R-BioPharm RIDASCREEN FAST Gliadin | No | 10 | 10 | Yes | Wheat, rye, barley | Gliadin | Yes |
| R-BioPharm RIDAQUICK Gliadin | No | 5 | No | Yes | Wheat, rye, barley | Gliadin | Yes |
| Tepnel BioSystems Wheat Gluten | AOAC |
160 2 - not validated |
16 | Yes | Wheat, triticale, rye | Omega gliadin | Yes |
| Tepnel BioSystems Gluten Rapid Test Kit | No |
50 - breads, etc 200 - "highly processed flour |
No | Yes | Wheat, triticale, rye | Omega gliadin | Yes |
a Information from manufacturers web sites:
Ingensa
Neogen Food Allergen Test Kits
R-BioPharm Food and Feed Analysis RIDASCREEN® Gliadin
b Immer et al., 2003.
| Study | Published | Test Population | Test Material | Dose Level(s) | Duration | Diagnostic Assessment (Biomarker) | Individual Response Data? |
|---|---|---|---|---|---|---|---|
|
Fasano, 2005; Abstract: Catassi et al., 2005b |
No; analysis is ongoing | 33 of 46 adults completed study | Not reported | 0, 10 or 50 mg gluten/day | 3 months | Intestinal biopsy, symptoms | Not reported |
| Catassi et al., 1993 | Yes | 20 children (10 each dose level) | Commercial crude gliadin | 100 mg or 500 mg gliadin/day | 4 weeks | Intestinal biopsy, symptoms | Yes |
| Ciclitera et al., 1984 | Yes | 1 adult | White flour milled from Kolibri strain of wheat | 10, 600, and 1000 mg gliadin | Intraduodenal infusion over 2 hr period; 3 doses on separate days | Intestinal biopsy | Yes |
| Ciclitera et al., 1984 | Yes | 3 adults | White flour milled from Kolibri strain of wheat | 1000 mg of 4 gliadin subfractions | Intraduodenal infusion each subfraction at variable intervals of 3 to 11 days | Intestinal biopsy, symptoms | Yes |
| Ciclitera et al., 1985 | Yes | 10 adults | Not reported; article states that gluten-free bread usually contains 0.2 to 0.4 mg gliadin/30-g slice | 6 slices/day Juvela gluten-free bread; oral | 6 weeks | Intestinal biopsy,symptoms | Yes |
| Montgomery et al, 1988 | Yes |
12 adults on strict gluten-free diet and 13 adults on low-gluten diet |
Not reported |
Gluten-free diet Low-gluten diet (2.5 to 5 gm gluten/day) |
Gluten-free diet: 6 to 27 months (mean 13 months); Low-gluten diet: 3 to 14 months (mean 6 months) |
Intestinal biopsy, symptoms, anti-gluten Ab | Yes, graphs |
| Sturgess et al, 1994 | Yes | 4 adults | Undigested gliadin prepared from Kolibri wheat flour by standard method; oligopeptides synthesized and analyzed | 1 gm gliadin or 200 mg of synthetic peptides/dose | 2 hours by infusion | Intestinal biopsy hourly for 6 hrs after start infusion | Yes; as percentage enteropathic change |
June 2005 Draft Report: Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food
March 2006 FDA's Responses to Public Comments on the Draft Report
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