Comparing Results vs 3rd PartiesUpdated 4 months ago

Understanding Blood Test Result Variations

1. Repeatability and Validity

We prioritize repeatability and validity in product development, using CLIA-certified and CAP-accredited labs that validate tests against venous draws. However, variability of up to 100% can occur due to differences in reagents and calibrators used by different labs, which we aim to disclose transparently.

2. Variability in Test Results

Different labs may produce inconsistent results, especially with immunoassays. A typical variation of 15% can happen even when testing the same sample on the same machine. For less common tests like Vitamin D and Testosterone, discrepancies exist based on the instruments used, prompting us to create a whitepaper for Vitamin D to enhance accuracy.

3. Challenges with Specific Biomarkers

Biomarkers such as testosterone and cortisol fluctuate daily and are influenced by various factors. Accurate comparisons would require simultaneous testing at multiple labs. Our tests are validated against venous draws, and studies show they respond to lifestyle changes. Serial measurements help establish baselines more reliably than single tests.

4. Commitment to Improving Accuracy

SiPhox is dedicated to enhancing at-home testing accuracy. Our new Silicon Photonic-based device will start validation this year, aiming for results in minutes. By 2025, we plan to replace our ADX collection card kits with SiPhox Home readers for quicker and more reliable results.