Inactivated pronase as the cause of false-positive results of serum cryptococcal antigen tests

T C Stoeckli1, W J Burman

  • 1Division of Infectious Diseases, University of Colorado Health Sciences Center, Denver, CO, USA. Thomas.Stoeckli@chuv.hospvd.ch

Insights

A batch of false-positive serum cryptococcal antigen tests in four acquired immunodeficiency syndrome patients suggests a problem with the test kit. The likely cause was an inactivated pronase vial, a previously unreported issue.

Area of Science:

  • Medical diagnostics
  • Infectious disease testing
  • Immunology

Background:

  • Acquired immunodeficiency syndrome (AIDS) patients are susceptible to cryptococcal infections.
  • Accurate diagnosis of cryptococcosis relies on sensitive serum cryptococcal antigen tests.
  • False-positive test results can lead to unnecessary treatment and patient anxiety.

Purpose of the Study:

  • To report a cluster of false-positive serum cryptococcal antigen test results in patients with acquired immunodeficiency syndrome.
  • To identify the potential cause of these erroneous test results.

Main Methods:

  • Retrospective review of four cases of acquired immunodeficiency syndrome patients presenting with headache.
  • Analysis of serum cryptococcal antigen test results within a specific 3-week period.
  • Investigation into the integrity and components of the diagnostic test kits used.

Main Results:

  • Four patients with acquired immunodeficiency syndrome exhibited false-positive serum cryptococcal antigen test results.
  • The cluster of false-positive results was linked to the inactivation of a pronase vial within the test kit.
  • This specific cause of test kit malfunction had not been previously documented.

Conclusions:

  • Inactivation of the pronase vial in serum cryptococcal antigen test kits can lead to false-positive results.
  • This highlights the importance of quality control and potential batch-specific issues in diagnostic assays.
  • Clinicians should be aware of this potential artifact, especially when interpreting results in high-risk populations like those with AIDS.