Notes from the Field: Use of Unvalidated Urine Mycotoxin Tests for the Clinical Diagnosis of Illness – United States, 2014

Details

• Journal Article:
  Morbidity and Mortality Weekly Report (MMWR)
• Personal Author:
  Kawamoto, Melody M. ; Page, Elena H.
• Description:
  In February 2014, CDC's National Institute for Occupational Safety and Health received a request for a health hazard evaluation from a union representative in an office building. A female employee reported the onset of symptoms involving multiple organ systems upon returning to work after a prolonged absence. The employee searched the Internet for descriptions of symptoms matching hers, found a laboratory offering "toxic mold testing" direct to consumers, and submitted a urine sample, despite the absence of musty odors and signs of fungal growth in her office. The laboratory reported "positive" concentrations of two mycotoxins: ochratoxin at 2.8 parts per billion (ppb) and tricothecenes at 0.4 ppb. The laboratory cutoff for "positive" was >/= 2.0 ppb for ochratoxin and >/= 0.2 ppb for tricothecenes. The interpretation accompanying the laboratory report said the results revealed that you have an unusual level of that mycotoxin(s) present in your body." The laboratory mentioned its Clinical Laboratory Improvement Amendments (CLIA) certification on its reports and noted that the urine mycotoxin testing was not approved by the Food and Drug Administration (FDA). FDA clearance or approval of a test provides assurance that the test has adequate analytical and clinical validation and that it is safe and effective. There is no FDA-approved test for mycotoxins in human urine. Persons using direct-to-consumer laboratory tests that have not been approved by FDA for diagnostic purposes and their health care providers need to understand that these tests might not be valid or clinically useful. [Description provided by NIOSH]
• Subjects:
  Diagnosis Environmental Health Fungi Health Care Facilities Workforce And Services Laboratories Mycoses Occupational Health Quality Control Safety Urine
• Keywords:
  Clinical-tests Diagnostic-tests Health-care Health-services Indoor-environmental-quality Laboratory-testing Medical-screening Molds Mycotoxins Office-workers Quality-standards Urinalysis

  More +
• Series:
  Weekly Report: Morbidity and Mortality Weekly Report (MMWR)
• ISSN:
  0149-2195 (print) ; 1545-861X (digital)
• Publisher:
  Centers for Disease Control and Prevention (CDC) (U.S.)
• Document Type:
  Text
• Genre:
  Journal Article
• Place as Subject:
  United States
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Division:
  DSHEFS - Division of Surveillance, Hazard Evaluations, and Field Studies
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Pages in Document:
  2 pdf pages
• Volume:
  64
• Issue:
  6
• NIOSHTIC Number:
  nn:20045762
• Citation:
  MMWR 2015 Feb; 64(6):157-158
• Email:
  epage@cdc.gov
• CAS Registry Number:
  Ochratoxins (CAS RN 37203-43-3)
• Federal Fiscal Year:
  2015
• Peer Reviewed:
  False
• Collection(s):
  Morbidity and Mortality Weekly Report (MMWR) National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:05065ae31e43e45fb0950b9681ac5ff478822229a38b5288af742758026fbfeb272ef215e28358d809083d1a2d337234e52d0423f9a902cedf1d9567b0499916
• Download URL:
  https://stacks.cdc.gov/view/cdc/183211/cdc_183211_DS1.pdf
• File Type:
  [PDF - 223.76 KB ]