Published 03/21/2022

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Development of a Laboratory Verification Protocol for Qualitative and Semi-Quantitative Detections in a Multiplex Syndromic Pneumonia Panel

Verification and quality control (QC) are critical components of implementing a diagnostic test in a clinical
laboratory and may be time-consuming and costly. A protocol was developed using control material designed in
collaboration with ZeptoMetrix®  to verify both qualitative and semi-quantitative detections for efficient system verification and QC.

The protocol was optimized using prototype NATtrol controls from ZeptoMetrix®, bronchoalveolar lavage, sputa and the BioFire® FilmArray® 2.0 and the BioFire® FilmArray® Torch Systems. Control materials were tested in the presence of clinical matrix or negative control. The pooling scheme was designed to generate both qualitative and semi-quantitative detections of high and low levels to demonstrate that the system can quantify a range of target levels and provide multiple bin detections in the same test.

ZeptoMetrix® Pneumonia Panel NATtrol Controls are packaged to allow maximum flexibility for laboratory validation and QC needs:

  • NATPPQ-BIO -semi-quantitative bacteria/antibiotic resistance markers at log level 10^4–10^5 cp/mL (Low) or 10^6– 10^7 cp/mL (High) levels
  • NATPPA-BIO - qualitative viruses and atypical bacteria
  • NATMR-BIO - synthetic MERS-CoV for qualitative detection (for use with BioFire Pneumonia Panel plus only)
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