PITFALLS OF MYCOTOXIN TESTING: EVIDENCE-BASED FINDINGS CONFIRM MYCOTOXIN ASSAYS USING ANTIBODY TESTING AND URINARY ELISA ARE BASED ON FLAWED SCIENCE
Main Article Content
Abstract
With the recent focus on diagnosis and treatment in the United States of chronic illness stemming from exposure to the interior of water-damaged buildings, there has been greater use of unsupported laboratory testing. Prior extensive published studies have provided rigorous support for the causation of illness called Chronic Inflammatory Response Syndrome (CIRS). Still, we have not yet seen any studies of exposure to mycotoxins alone that have withstood peer review. The absence of control groups, prospective case-control studies, and placebo-controlled studies makes conclusions of causation impossible. In contrast, such basic studies are well represented in the peer-reviewed literature on CIRS.
Article Details
How to Cite
R, Shoemaker et al.
PITFALLS OF MYCOTOXIN TESTING: EVIDENCE-BASED FINDINGS CONFIRM MYCOTOXIN ASSAYS USING ANTIBODY TESTING AND URINARY ELISA ARE BASED ON FLAWED SCIENCE.
Medical Research Archives, [S.l.], v. 14, n. 2, feb. 2026.
ISSN 2375-1924.
Available at: <https://esmed.org/MRA/mra/article/view/7260>. Date accessed: 02 mar. 2026.
doi: https://doi.org/10.18103/mra.v14i2.7260.
Section
Research Articles
The Medical Research Archives grants authors the right to publish and reproduce the unrevised contribution in whole or in part at any time and in any form for any scholarly non-commercial purpose with the condition that all publications of the contribution include a full citation to the journal as published by the Medical Research Archives.
References
1. Alshannaq AF, Yu JH. Occurrence, Toxicity, and Analysis of Major Mycotoxins in Food. International Journal of Environmental Research and Public Health. 2017;14(6):632.
2. Turner PC, Flannery BM, Isitt C, Ali M, Pestka JJ. The role of biomarkers in evaluating human health concerns and fungal contaminants in food. Nutrition Reviews. 2012;70(6):1-13.
3. Tittlemier S, Cramer B, DeRosa MC, et al. Developments in analytical techniques for mycotoxin determination: an update for 2023-24. World Mycotoxin Journal. 2025;18(1):71-97.
4. Shoemaker RC. Urinary mycotoxins: A review of contaminated buildings and food in search of a biomarker separating sick patients from controls. Intern Med Rev. 2019;5(6):1-35.
5. Shoemaker R, House DE. A time-series study of sick building syndrome: chronic, biotoxin-associated illness from exposure to water-damaged buildings. Neurotoxicol Teratol. 2005; 27:29-46.
6. Shoemaker RC, House DE. Sick building syndrome and exposure to water-damaged buildings: time series study, clinical trial and mechanisms. Neurotoxicol Teratol. 2006; 28:573-588.
7. Shoemaker R, Lin K. Inside indoor air quality: Environmental Relative Moldiness Index (ERMI). Filtration News. 2007; 32:36.
8. Shoemaker R, House D, Ryan J. Vasoactive intestinal polypeptide corrects chronic inflammatory response syndrome acquired following exposure to water-damaged buildings. Health. 2013;5(3): 396-401.
9. Shoemaker R, House D, Ryan J. Structural brain abnormalities in patients with inflammatory illness acquired following exposure to water-damaged buildings: a volumetric MRI study using NeuroQuant®. Neurotoxicol Teratol. 2014; 45:18-26.
10. Berndtson K, McMahon S, Ackerley M, Rapaport S, Gupta S, Shoemaker RC. Consensus Statement, Part 1: Medically sound investigation and remediation of water-damaged buildings in cases of CIRS-WDB. Center for Research on Biotoxin-Associated Illness; Pocomoke, MD. 2016.
11. Ryan C, Shoemaker RC. RNA-Seq on patients with chronic inflammatory response syndrome treated with vasoactive intestinal peptide shows a shift in metabolic state and innate immune functions that coincide with healing. Med Res Arch. 2016;4(7).
12. Shoemaker RC, Katz D, Ackerley M, Rapaport S, McMahon SW, Berndtson K, Ryan JC. Intranasal VIP safely restores volume to multiple gray matter nuclei in patients with chronic inflammatory response syndrome. Intern Med Rev. 2017:1-14.
13. Shoemaker R, Heyman A, Lark D. Transcriptomics and brain volumetrics define the causes of cognitive impairment in patients with chronic inflammatory response syndrome and support the use of VIP in treatment. Med Res Arch. 2023;11(3).
14. Singh J, Mehta A. Rapid and sensitive detection of mycotoxins by advanced and emerging analytical methods: A review. Food Science & Nutrition. 2020;8(3):1474-1499.
15. Sulyok M, Stadler D, Steiner DJ, Krska R. Validation of an LC-MS/MS-based dilute-and-shoot approach for the quantification of >500 mycotoxins and other secondary metabolites in food crops. Analytical and Bioanalytical Chemistry. 2020;412: 2489-2509.
16. Fontana MEZ, da Silva RC, dos Santos ID, et al. Comprehensive assessment of clean-up strategies for optimizing an analytical multi-method to determine pesticides and mycotoxins in Brazilian medicinal herbs using QuEChERS-LC-TQ-MS/MS. Analytical Methods. 2024;16(31):2921-2940.
17. Garg K, Villavicencio-Aguilar F, Solano-Rivera F, et al. Analytical Validation of a Direct Competitive ELISA for Multiple Mycotoxin Detection in Human Serum. Toxins. 2022;14(11):727.
18. Cvak B, Warth B, Atehnkeng J, et al. Evaluating the Performance of Lateral Flow Devices for Total Aflatoxins with Special Emphasis on Their Robustness under Sub-Saharan Conditions. Toxins. 2021;13 (11):742.
19. Logan N, Cao C, Freitag S, et al. Advancing Mycotoxin Detection in Food and Feed: Novel Insights from Surface-Enhanced Raman Spectroscopy (SERS). Advanced Materials. 2024;36(3):2309625.
20. Veenuttranon K, Lu X, Geng N, Zhang H, Chen J. A Portable Integrated Duplex Label-Free Electrochemical Immunosensor Constructed from a Nanozyme-Tuned Metal-Organic Framework for Dual Mycotoxin Detection. Analytical Chemistry. 2025;97(29):14209-14225.
21. Cortese M, Gigliobianco MR, Magnoni F, et al. Compensate for or Minimize Matrix Effects? Strategies for Overcoming Matrix Effects in Liquid Chromatography-Mass Spectrometry Technique. Molecules. 2020;25(13):3047.
22. Solfrizzo M, Alldrick AJ, van Egmond HP. The use of mycotoxin methodology in practice: a need for harmonization. World Mycotoxin Journal. 2009; 2(3):1-10.
23. M. Rychlik et al., "Proposal of a comprehensive definition of modified and other forms of mycotoxins including masked mycotoxins," Springer Science Business Media, Jun. 2014,
doi: https://doi.org/10.1007/s12550-014-0203-5.
24. Arce-López B, Lizarraga E, Vettorazzi A, González-Peñas E. Human Biomonitoring of Mycotoxins in Blood, Plasma and Serum in Recent Years: A Review. Toxins. 2020;12(3):147.
25. McKeon HP, Schepens MAA, van den Brand A, et al. Assessment of Mycotoxin Exposure and Associated Risk in Pregnant Dutch Women: The Human Biomonitoring Approach. Toxins. 2024;16 (6):278.
26. Cramer B, Visintin L, Maris E, Kuhn M, Degen GH, Turner PC, Humpf HU, De Saeger S. Human biomonitoring of mycotoxins: key challenges and future directions. Mycotoxin Res. 2025 Dec 23;42 (1):13.
27. Kensler TW, Roebuck BD, Wogan GN, Groopman JD. Aflatoxin: A 50-Year Odyssey of Mechanistic and Translational Toxicology. Toxicological Sciences. 2010;120(1): S28-S48.
28. E. D. P. Nunes, B. A. D. Pestana, and B. B. B. Pereira, "Human biomonitoring and environmental health: a critical review of global exposure patterns, methodological challenges and research gaps," Journal of Toxicology and Environmental Health. Part B, Critical Reviews, Jul. 2025, doi: 10.1080/10 937404.2025.2529845.
29. Parker LA, Chilet-Rosell E, Hernández-Aguado I, et al. Diagnostic Biomarkers: Are We Moving from Discovery to Clinical Application? Clinical Chemistry. 2018 ;64(11) :2854.
30. Huang Q, Jiang K, Tang Z, et al. Exposure Assessment of Multiple Mycotoxins and Cumulative Health Risk Assessment: A Biomonitoring-Based Study in the Yangtze River Delta, China. Toxins. 2021;13(2):103.
31. N. Kyei, B. Cramer, H. Humpf, G. Degen, N. Ali, and S. Gabrysch, "Assessment of multiple mycotoxin exposure and its association with food consumption: a human biomonitoring study in a pregnant cohort in rural Bangladesh," Archives of Toxicology, Apr. 2022, doi: 10.1007/s00204-022-03288-0.
32. Benkerroum N. Retrospective and Prospective Look at Aflatoxin Research and Development from a Practical Standpoint. International Journal of Environmental Research and Public Health. 2019;16 (19):3633.
33. Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence-based medicine: what it is and what it is not. BMJ. 1996;312(7023):71-72.
34. Guyatt G, Rennie D, Meade MO, Cook DJ. Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice. 2nd ed. AMA Press; 2008.
35. Bossuyt PM, Reitsma JB, Bruns DE, et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. BMJ. 2003;327(7413):41-44.
36. Clinical and Laboratory Standards Institute (CLSI). Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline. CLSI document C28-A3. Wayne, PA ; 2008.
37. Pepe MS, Étions R, Feng Z, et al. Phases of biomarker development for early detection of disease. Biometrics. 2001;57(2):345-352.
38. Hulka BS, Wilcosky TC, Griffith JD. Biological markers in epidemiology. Am J Epidemiol. 1990; 132(1):1-13.
2. Turner PC, Flannery BM, Isitt C, Ali M, Pestka JJ. The role of biomarkers in evaluating human health concerns and fungal contaminants in food. Nutrition Reviews. 2012;70(6):1-13.
3. Tittlemier S, Cramer B, DeRosa MC, et al. Developments in analytical techniques for mycotoxin determination: an update for 2023-24. World Mycotoxin Journal. 2025;18(1):71-97.
4. Shoemaker RC. Urinary mycotoxins: A review of contaminated buildings and food in search of a biomarker separating sick patients from controls. Intern Med Rev. 2019;5(6):1-35.
5. Shoemaker R, House DE. A time-series study of sick building syndrome: chronic, biotoxin-associated illness from exposure to water-damaged buildings. Neurotoxicol Teratol. 2005; 27:29-46.
6. Shoemaker RC, House DE. Sick building syndrome and exposure to water-damaged buildings: time series study, clinical trial and mechanisms. Neurotoxicol Teratol. 2006; 28:573-588.
7. Shoemaker R, Lin K. Inside indoor air quality: Environmental Relative Moldiness Index (ERMI). Filtration News. 2007; 32:36.
8. Shoemaker R, House D, Ryan J. Vasoactive intestinal polypeptide corrects chronic inflammatory response syndrome acquired following exposure to water-damaged buildings. Health. 2013;5(3): 396-401.
9. Shoemaker R, House D, Ryan J. Structural brain abnormalities in patients with inflammatory illness acquired following exposure to water-damaged buildings: a volumetric MRI study using NeuroQuant®. Neurotoxicol Teratol. 2014; 45:18-26.
10. Berndtson K, McMahon S, Ackerley M, Rapaport S, Gupta S, Shoemaker RC. Consensus Statement, Part 1: Medically sound investigation and remediation of water-damaged buildings in cases of CIRS-WDB. Center for Research on Biotoxin-Associated Illness; Pocomoke, MD. 2016.
11. Ryan C, Shoemaker RC. RNA-Seq on patients with chronic inflammatory response syndrome treated with vasoactive intestinal peptide shows a shift in metabolic state and innate immune functions that coincide with healing. Med Res Arch. 2016;4(7).
12. Shoemaker RC, Katz D, Ackerley M, Rapaport S, McMahon SW, Berndtson K, Ryan JC. Intranasal VIP safely restores volume to multiple gray matter nuclei in patients with chronic inflammatory response syndrome. Intern Med Rev. 2017:1-14.
13. Shoemaker R, Heyman A, Lark D. Transcriptomics and brain volumetrics define the causes of cognitive impairment in patients with chronic inflammatory response syndrome and support the use of VIP in treatment. Med Res Arch. 2023;11(3).
14. Singh J, Mehta A. Rapid and sensitive detection of mycotoxins by advanced and emerging analytical methods: A review. Food Science & Nutrition. 2020;8(3):1474-1499.
15. Sulyok M, Stadler D, Steiner DJ, Krska R. Validation of an LC-MS/MS-based dilute-and-shoot approach for the quantification of >500 mycotoxins and other secondary metabolites in food crops. Analytical and Bioanalytical Chemistry. 2020;412: 2489-2509.
16. Fontana MEZ, da Silva RC, dos Santos ID, et al. Comprehensive assessment of clean-up strategies for optimizing an analytical multi-method to determine pesticides and mycotoxins in Brazilian medicinal herbs using QuEChERS-LC-TQ-MS/MS. Analytical Methods. 2024;16(31):2921-2940.
17. Garg K, Villavicencio-Aguilar F, Solano-Rivera F, et al. Analytical Validation of a Direct Competitive ELISA for Multiple Mycotoxin Detection in Human Serum. Toxins. 2022;14(11):727.
18. Cvak B, Warth B, Atehnkeng J, et al. Evaluating the Performance of Lateral Flow Devices for Total Aflatoxins with Special Emphasis on Their Robustness under Sub-Saharan Conditions. Toxins. 2021;13 (11):742.
19. Logan N, Cao C, Freitag S, et al. Advancing Mycotoxin Detection in Food and Feed: Novel Insights from Surface-Enhanced Raman Spectroscopy (SERS). Advanced Materials. 2024;36(3):2309625.
20. Veenuttranon K, Lu X, Geng N, Zhang H, Chen J. A Portable Integrated Duplex Label-Free Electrochemical Immunosensor Constructed from a Nanozyme-Tuned Metal-Organic Framework for Dual Mycotoxin Detection. Analytical Chemistry. 2025;97(29):14209-14225.
21. Cortese M, Gigliobianco MR, Magnoni F, et al. Compensate for or Minimize Matrix Effects? Strategies for Overcoming Matrix Effects in Liquid Chromatography-Mass Spectrometry Technique. Molecules. 2020;25(13):3047.
22. Solfrizzo M, Alldrick AJ, van Egmond HP. The use of mycotoxin methodology in practice: a need for harmonization. World Mycotoxin Journal. 2009; 2(3):1-10.
23. M. Rychlik et al., "Proposal of a comprehensive definition of modified and other forms of mycotoxins including masked mycotoxins," Springer Science Business Media, Jun. 2014,
doi: https://doi.org/10.1007/s12550-014-0203-5.
24. Arce-López B, Lizarraga E, Vettorazzi A, González-Peñas E. Human Biomonitoring of Mycotoxins in Blood, Plasma and Serum in Recent Years: A Review. Toxins. 2020;12(3):147.
25. McKeon HP, Schepens MAA, van den Brand A, et al. Assessment of Mycotoxin Exposure and Associated Risk in Pregnant Dutch Women: The Human Biomonitoring Approach. Toxins. 2024;16 (6):278.
26. Cramer B, Visintin L, Maris E, Kuhn M, Degen GH, Turner PC, Humpf HU, De Saeger S. Human biomonitoring of mycotoxins: key challenges and future directions. Mycotoxin Res. 2025 Dec 23;42 (1):13.
27. Kensler TW, Roebuck BD, Wogan GN, Groopman JD. Aflatoxin: A 50-Year Odyssey of Mechanistic and Translational Toxicology. Toxicological Sciences. 2010;120(1): S28-S48.
28. E. D. P. Nunes, B. A. D. Pestana, and B. B. B. Pereira, "Human biomonitoring and environmental health: a critical review of global exposure patterns, methodological challenges and research gaps," Journal of Toxicology and Environmental Health. Part B, Critical Reviews, Jul. 2025, doi: 10.1080/10 937404.2025.2529845.
29. Parker LA, Chilet-Rosell E, Hernández-Aguado I, et al. Diagnostic Biomarkers: Are We Moving from Discovery to Clinical Application? Clinical Chemistry. 2018 ;64(11) :2854.
30. Huang Q, Jiang K, Tang Z, et al. Exposure Assessment of Multiple Mycotoxins and Cumulative Health Risk Assessment: A Biomonitoring-Based Study in the Yangtze River Delta, China. Toxins. 2021;13(2):103.
31. N. Kyei, B. Cramer, H. Humpf, G. Degen, N. Ali, and S. Gabrysch, "Assessment of multiple mycotoxin exposure and its association with food consumption: a human biomonitoring study in a pregnant cohort in rural Bangladesh," Archives of Toxicology, Apr. 2022, doi: 10.1007/s00204-022-03288-0.
32. Benkerroum N. Retrospective and Prospective Look at Aflatoxin Research and Development from a Practical Standpoint. International Journal of Environmental Research and Public Health. 2019;16 (19):3633.
33. Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence-based medicine: what it is and what it is not. BMJ. 1996;312(7023):71-72.
34. Guyatt G, Rennie D, Meade MO, Cook DJ. Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice. 2nd ed. AMA Press; 2008.
35. Bossuyt PM, Reitsma JB, Bruns DE, et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. BMJ. 2003;327(7413):41-44.
36. Clinical and Laboratory Standards Institute (CLSI). Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline. CLSI document C28-A3. Wayne, PA ; 2008.
37. Pepe MS, Étions R, Feng Z, et al. Phases of biomarker development for early detection of disease. Biometrics. 2001;57(2):345-352.
38. Hulka BS, Wilcosky TC, Griffith JD. Biological markers in epidemiology. Am J Epidemiol. 1990; 132(1):1-13.