Sample stability is a crucial factor directly impacting the accuracy and reliability of hydrogen and methane breath testing results. Ensuring that samples remain stable throughout collection, storage, and transportation is essential for maintaining the integrity of the breath test, which detects conditions such as Small Intestinal Bacterial Overgrowth (SIBO), Intestinal Methanogen Overgrowth (IMO), and carbohydrate malabsorption disorders.
What is Sample Stability in Breath Testing?
Sample stability refers to the ability of a collected breath sample to maintain its original composition without degradation or alteration during storage and transport. This is vital in breath testing, as the concentration of hydrogen (H₂) and methane (CH₄) gases in the sample must accurately reflect the patient’s intestinal environment at the time of collection. Any changes in the sample’s composition could lead to incorrect diagnostic conclusions and affect patient care.
The Importance of Sample Stability for Accurate Results
- Preservation of Gas Concentrations: The levels of hydrogen and methane in a breath sample are delicate and can be influenced by various factors such as temperature and time. Ensuring stability means the sample’s gas concentrations remain unchanged, allowing for precise measurement and interpretation.
- Minimizing Contamination Risks: A stable sample is less susceptible to contamination from external gases or substances that could skew the results. This is particularly important for ensuring the reliability of the test outcomes.
- Consistency Across Testing Conditions: Stability ensures that samples collected under different conditions (e.g., at-home collection vs. clinical settings) can be reliably compared. This uniformity is essential for establishing standardized diagnostic criteria and for longitudinal studies tracking patient progress over time.
CDI’s Approach to Ensuring Sample Stability
At Commonwealth Diagnostics International (CDI), we prioritize sample stability in our hydrogen and methane breath testing protocols. Here’s how we do it:
- State-of-the-Art Collection Kits: Our FDA registered and CE Marked breath test kits are purposefully designed with materials that protect the sample from environmental variables. They maintain the internal atmosphere required to prevent the degradation of hydrogen and methane concentrations.
- Rigorous Validation Processes: CDI’s testing protocols undergo comprehensive validation to ensure that sample integrity is preserved from collection through analysis. Our ISO 13485 certification reflects our commitment to maintaining the highest sample handling and testing standards.
- Packaging & Logistics Testing: CDI’s breath test kits are designed to preserve accurate sample values through a wide range of pressures, temperatures, and physical stresses put onto the kits during transport to ensure that samples arrive at our CLIA-certified lab in the same condition as when they were collected. Each breath test kit undergoes extensive package, product, and material design testing and is verified by DDL, an ISO/IEC 17025 accredited, third-party testing laboratory.
Transparency in Testing
CDI is committed to transparency in our testing processes. While we do not provide raw gas concentrations, our results show the hydrogen and methane values after accounting for potential variability. We also incorporate CO2 correction into our reporting methodology to account for any dilution by ambient air.
In light of CDI’s stringent validation and quality controls and to guarantee sample stability, CDI allows a two-week window from when the test is taken for tests to be received and analyzed back at our laboratory. This approach ensures that healthcare providers receive the most accurate diagnostic data to guide patient care.
The Future of Breath Testing
As breath testing technology advances, ensuring sample stability will remain a cornerstone of accurate diagnostics. CDI continues to deliver reliable, patient-friendly testing solutions by maintaining stringent controls over sample handling and processing. Trust us to provide “Breath Testing Done Right” with every sample meticulously managed for optimal accuracy.
Learn more about our Laboratory, Technology, and Science and how we ensure quality and reliability in every breath test.
