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Long-Term Stability of a Portable Carbon Monoxide Single-Breath Diffusing Capacity Instrument.

Laura Gochicoa-Rangel1, Rogelio Pérez-Padilla1, Juan Carlos Vázquez-García1

  • 1Departamento de Fisiología Respiratoria, Instituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas," México, Distrito Federal, México.

Respiratory Care
|September 29, 2016
PubMed
Summary
This summary is machine-generated.

This study demonstrates that a portable diffusing capacity of the lung for carbon monoxide (DLCO) instrument remained stable over three years. Weekly biological controls and a DLCO simulator confirmed instrument accuracy and reliability for quality assurance.

Keywords:
biological controldiffusing capacity for carbon monoxidequality controlsimulator

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Area of Science:

  • Pulmonary Function Testing
  • Medical Device Quality Assurance
  • Respiratory Medicine

Background:

  • The 2005 ATS/ERS guidelines recommend weekly biological control tests or DLCO simulators for quality assurance of diffusing capacity of the lung for carbon monoxide (DLCO) instruments.
  • Limited data exists on the effectiveness of these quality assurance programs in real-world clinical settings.
  • This study addresses the need for long-term stability analysis of portable DLCO devices.

Purpose of the Study:

  • To evaluate the long-term stability and accuracy of a portable DLCO instrument.
  • To assess the efficacy of a weekly biological control program in detecting instrument drift.
  • To compare the performance of a DLCO simulator and biological controls for quality assurance.

Main Methods:

  • A new EasyOne Pro system was utilized for DLCO measurements over three years in a large clinical laboratory.
  • Instrument accuracy was verified using a DLCO simulator with two reference gas concentrations.
  • A healthy individual performed weekly self-testing as a biological control to monitor for instrument drift.

Main Results:

  • Over 5,000 DLCO maneuvers were performed, with no failures in automated daily checks or calibration.
  • The DLCO simulator showed minimal differences, with mean values of -0.91 ± 1.33 and -0.61 ± 1.45 mL/min/mm Hg for the two concentrations.
  • Weekly biological control tests demonstrated high stability, with a mean DLCO of 30.8 ± 1.7 mL/min/mm Hg, a 5.4% coefficient of variation, and 2.5 mL/min/mm Hg repeatability.

Conclusions:

  • The portable DLCO instrument exhibited stable performance over a three-year period without requiring manual recalibration.
  • Weekly biological control testing proved effective in evaluating the instrument's performance, comparable to a DLCO simulator.
  • The findings support the implementation of biological controls as a reliable component of long-term quality assurance for DLCO measurement devices.