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False positive tuberculosis skin test results

J C Grabau1, G T DiFerdinando, L F Novick

  • 1Bureau of Tuberculosis Control, New York State Department of Health, Albany 12237-0627, USA.

Public Health Reports (Washington, D.C. : 1974)
|November 1, 1995
PubMed
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Tuberculosis skin tests (Mantoux method) can yield inaccurate results. Product quality issues, like particulate matter in purified protein derivative, caused false positive tuberculosis test reactions in 1992.

Area of Science:

  • Public Health
  • Immunology
  • Diagnostic Testing

Background:

  • Tuberculosis (TB) re-emergence necessitates reliable diagnostic tools.
  • Tuberculin skin testing, specifically the Mantoux method, is crucial for identifying TB infection.
  • Limitations exist, including false positives and negatives, impacting public health strategies.

Purpose of the Study:

  • To investigate the cause of unexpected false positive tuberculin skin test reactions.
  • To examine potential product-related issues affecting diagnostic accuracy.
  • To ensure the reliability of purified protein derivative (PPD) for TB screening.

Main Methods:

  • Retrospective analysis of false positive Mantoux test reactions in New York State, 1992.
  • Examination of purified protein derivative (PPD) lots suspected of causing adverse reactions.

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  • Laboratory analysis by the Food and Drug Administration (FDA) to identify product contaminants.

    • Main Results:

    • At least 25 false positive skin tests were linked to a specific manufacturer's PPD lot.
    • An altered appearance of the PPD product was noted.
    • FDA analysis confirmed particulate matter in the implicated PPD vials.

    Conclusions:

    • Product quality control is critical for the accuracy of tuberculin skin tests.
    • Contaminated diagnostic reagents can lead to misdiagnosis and public health concerns.
    • Vigilance in monitoring diagnostic product lots is essential for maintaining test efficacy.