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Importance of Adequate qPCR Controls in Infection Control.

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  • 1Faculty of Medicine, McGill University, Montreal, QC H3G 2M1, Canada.

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Summary
This summary is machine-generated.

Respiratory screening assays need Sample Adequacy Controls (SAC) to prevent false negatives from poor sample quality. Implementing SAC improves infection control, especially during pandemics, by identifying and addressing inadequate samples.

Keywords:
assayclinicalcontrolfalse negativeinfectionlaboratorypandemicqPCRqualitysample

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Area of Science:

  • Clinical diagnostics
  • Infectious disease surveillance

Background:

  • Respiratory screening assays without Sample Adequacy Controls (SAC) risk inadequate sample quality and false-negative results.
  • Sub-optimal sample quality can compromise infection control measures, posing significant risks during pandemics.

Purpose of the Study:

  • To provide clinical evidence for the importance of Sample Adequacy Controls (SAC) in respiratory screening.
  • To demonstrate the impact of inadequate sample quality on test result accuracy and infection control.

Main Methods:

  • Empirically establishing a quantitative sample adequacy threshold by analyzing the relationship between sample adequacy scores and positive result frequency.
  • Analyzing a large volume of tests to achieve statistically valid results for SAC threshold determination.

Main Results:

  • A subset of results failing minimal sample adequacy criteria showed a significantly lower frequency of positivity compared to adequate samples.
  • This finding provides the first clear clinical evidence of the impact of sample adequacy on respiratory screening accuracy.

Conclusions:

  • Flagging or re-sampling results that do not meet minimal sample adequacy criteria is a crucial mitigation strategy.
  • Implementing robust SAC can dramatically improve the effectiveness of infection control measures and public health outcomes.