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Trend-based quality assurance of binary urinary antigen tests.

Susanne Sütterlin1,2, Anders Olof Larsson3

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Summary

Monitoring positivity trends in urinary antigen (uAg) tests offers a practical quality assurance (QA) method for pneumococcal and Legionella diagnostics. This approach effectively tracks long-term test performance and detects analytical drift in binary assays.

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Area of Science:

  • Clinical diagnostics
  • Microbiology
  • Public health surveillance

Background:

  • Binary diagnostic assays, like urinary antigen (uAg) tests, offer rapid results but lack quantitative data for traditional quality control.
  • Ensuring the reliability of these tests is crucial for accurate patient diagnosis and effective public health strategies.

Purpose of the Study:

  • To evaluate the utility of long-term monitoring of test positivity patterns for quality assurance (QA) of pneumococcal and Legionella uAg assays.
  • To determine if trend analysis can serve as a practical QA tool for binary diagnostic tests.

Main Methods:

  • Retrospective analysis of 17,356 pneumococcal and 15,280 Legionella uAg tests from Uppsala County, Sweden (2007-2024).
  • Assessment of positivity trends over time, including seasonal and demographic variations.
  • Application of interquartile range (IQR) thresholds for outlier detection to identify potential analytical drift.

Main Results:

  • Pneumococcal positivity showed seasonal variation and was higher in children and females; Legionella positivity varied annually.
  • QA intervals using IQR thresholds indicated long-term stability (7.4% pneumococcus, 0.7% Legionella).
  • Outliers correlated with known epidemiological events, demonstrating the method's sensitivity.

Conclusions:

  • Long-term monitoring of positivity trends is a feasible strategy for QA of binary diagnostic tests.
  • This approach can complement conventional QA methods and effectively detect analytical drift in uAg assays.