Variations in FVC and FEV Biologic Quality Control Measures in a Global Multi-Center Clinical Trial.

Background: Although quality control standards are recommended to ensure accurate test results, the coefficient of variation for the FVC and FEV biologic quality control (BioQC) is not specified. The primary aim of this study was to evaluate variations in spirometry BioQCs in a large and diverse cohort of individuals to determine an acceptable standard for the coefficient of variation.

Methods: The FVC and FEV biologic control data were secondary analyses from an inhaled medication trial that was conducted over 3 y ending in 2018 that included 114 laboratories.