Our new state-of-the-art laboratory offers many features that separate us from others in our field offering breath testing services, including but not limited to favorable increases in sample intake efficiency, analytical accuracy, quality assurance, and result turnaround time. We also utilize an exclusive collection tube that ensures the stability of the breath sample is maintained for up to two weeks after collection across a wide range of temperatures (-4 to 104 °F).
We only use validated gas chromatography (GC) instruments and methods in our laboratory with a robust QA/QC quality system that was developed in accordance with CLIA high complexity guidelines. This ensures both our instrument performance and technical staff training are maintained to ensure accuracy and consistency across all patients tested through CDI. In addition, CDI uses National Institute of Standards and Technology (NIST) traceable gas standards to calibrate our GC instruments to ensure the most accurate sample detection.
CDI has designed an automated, custom GC configuration into our analysis process using one of the premier manufacturers in the GC market. Our laboratory has developed an optimal combination of custom component parts, the use of a two-detector system, and specific method parameters to make our instruments more accurate, precise, and sensitive in detecting all three gasses of interest in breath testing: hydrogen (H2), methane (CH4), and carbon dioxide (CO2). CDI’s customized GCs also use high-purity reference gasses to increase signal-to-noise ratios which improves sample detection limits.
CDI’s GC instrumentation has fully automated sample extraction for a higher sample throughput, increased consistency in samples across all patients, and a smaller injection volume which allows for repeat analysis within the same sample if necessary. This technology also enables CDI to be more accurate in the test results we deliver through automatic data transfers directly from the instrument into finalized result reports, which improves data integrity and reduces the risk of transcription errors common with other GC instrumentation.
CDI’s breath testing method allows a wider linear range than other instrumentation on the market, which spans from 3 to 1000 ppm for hydrogen, 3 to 1000 ppm for methane, and 0.2 to 10% for carbon dioxide. Our method also maintains an accuracy across the entire linear range greater than 90% for each trace gas. The consistency of samples through our instrumentation is ± 2 ppm for hydrogen and methane and ± 0.1% for carbon dioxide which is excellent precision between samples according to GC industry standards.