Liberty Analyzer WBC System: Healthy Volunteer Blood Study

The Liberty Analyzer WBC System Reference Interval Study is an important observational research project designed to establish normal ranges for white blood cell (WBC) counts in healthy adults. This study will help doctors better interpret test results from this innovative blood analysis system, ultimately improving patient care.

This study will enroll approximately 300 healthy adult volunteers aged 21 years or older. Participants will provide a small blood sample (capillary sample) that will be analyzed by the Liberty Analyzer WBC System. The main goal is to determine what counts as normal ranges for both total white blood cells and specific types called granulocytes.

To ensure the most accurate results, the study has very specific eligibility requirements. Volunteers must be in good health without any chronic medical conditions like diabetes, high blood pressure, or anemia. The researchers also exclude people who have had recent illnesses, surgeries, vaccinations, or blood donations that might temporarily affect blood test results.

The study pays special attention to factors that could influence white blood cell counts, including:

• Recent infections or inflammation
• Certain medications
• Chronic health conditions
• Nutritional status (like iron levels)
• Recent medical procedures

Participants will be screened through both health questionnaires and laboratory tests to confirm they meet all health requirements. Even after enrollment, some volunteers might be excluded if their standard blood tests show any abnormalities.

This type of research is critically important for several reasons:

1. It helps establish what normal results should look like for this specific testing system
2. It ensures the device works properly across different healthy individuals
3. It provides data that will help doctors make accurate diagnoses
4. It contributes to our overall understanding of normal blood values

White blood cell tests are among the most common medical tests performed worldwide. They help detect infections, monitor immune system function, and screen for many health conditions. Having accurate reference ranges is essential for proper medical decision-making.

The study will be conducted by Entia Ltd, with Hannah Rawlinson-Smith and the Entia Clinical Team serving as primary contacts. The research is scheduled to run from August to December 2025.

For potential volunteers, it's important to understand that this study involves just one visit with a simple finger-prick blood test. There are no experimental treatments or medications involved - researchers are simply observing normal blood values in healthy people.

Studies like this represent the foundation of good medical testing. Before any diagnostic device can be used in clinical practice, it must first be carefully calibrated against healthy populations. This ensures that when doctors see abnormal results in sick patients, they can be confident those results truly indicate a health problem rather than just normal variation.

The detailed exclusion criteria demonstrate how carefully researchers must control these studies to get reliable results. Even temporary factors like recent tattoos or vaccinations can affect blood tests, which is why they're included in the exclusion list.

This research will ultimately benefit all patients by:

• Improving the accuracy of white blood cell testing
• Helping identify abnormal results more reliably
• Contributing to better patient outcomes through more precise diagnoses
• Supporting the development of improved medical technology

While the study itself is relatively simple, its impact on future patient care could be significant. Establishing proper reference ranges is a crucial step in bringing any new diagnostic technology into clinical use.