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POCT for Clinical Trials and Research

POCT for Clinical Trials and Research

In recent years, researchers have integrated more advanced POCT equipment in clinical trials to provide results faster than local labs.

Clinical trials often require participants to have specific characteristics. Some examples of clinical trial POCT include pregnancy, glucose, oxygen levels, and flu tests. Researchers can verify the status of participants at the clinical trial site. POCT screening can exclude participants who do not meet study requirements.

A major application of point of care testing product testing in clinical trials is rapid CBC testing. Researchers can obtain quantitative CBC results in just a few minutes.

Ⅰ. The application of rapid CBC testing for point of care testing products in clinical trials includes:

1. Point of care testing products identify participants with anemia

A rapid CBC test usually includes red blood cell, hemoglobin, and hematocrit counts. If any of these are low, it may indicate that a person has anemia. In clinical trials involving anemic subjects, a rapid CBC test can quickly confirm the presence of disease.

2. Point of care testing products identify participants with blood disorders

Just like anemia, other blood disorders can be quickly identified using a rapid CBC test. Some of the diseases that can be found include autoimmune diseases, bone marrow diseases, leukemias, lymphomas, myeloproliferative neoplasms, myelodysplastic syndromes, sickle cell disease, thalassemias, and cancers that have spread to the bone marrow.

3. Infection screening for point of care testing products

Rapid CBC tests can quickly identify participants with infections (high or low WBC counts) in clinical trials to develop better treatments for immune diseases. This means that infected patients can receive life-saving treatment quickly. If researchers spot an infection quickly, they can also find the root cause faster.

4. Point of care testing products to monitor patient response to clinical trial drugs (companion diagnostics).

A rapid post-treatment CBC test can help monitor a patient's response to a clinical trial drug. With frequent CBC tests, researchers can quickly stop treatment if a patient experiences extreme adverse reactions. Frequent CBC testing can also improve patient compliance, as it can identify patients who are not following prescribed treatments properly.

Ⅱ. Three case studies of point of care testing products used in clinical trials and research:

1. Screen and register for a single visit

In one flu study, researchers used a POCT device to test participants for the flu, getting results quickly and enrolling them immediately. Another option is to send the patient home to wait for the lab results before enrolling. Some of these patients may have become ill and have not returned to registration.

2. Reduce the screen failure rate

In a global chronic kidney disease clinical trial, researchers prescreened participants using a Point of care test product device. They tested estimated glomerular filtration rate (GFR) and urinary albumin-creatinine ratio (UACR).

3. Get faster results

In a rare disease study, scientists measured C-reactive protein (CRP) using a POCT manufacturer's POCT device. The test allowed them to identify patients with "heart attack-like" symptoms.

*Not all products with the above mentioned methodologies or analytes on sale can be used for POCT. Please refer to Insturctions for Use of your products for the detailed intended use.