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The purpose of the Kaligia Biosciences KBS Systems 1.0(b) analyte monitoring device is to measure the blood analyte levels in patients. The KBS Systems 1.0(b) device avoids the common practice of accessing the vein to draw blood for conventional laboratory analysis. Instead, the KBS Systems 1.0(b) device uses Raman Spectroscopy to acheive the measurement of various blood analytes through the use of only approximately 40µl of blood. Such a small volume of blood can be sampled via a finger prick procedure rather than needing a larger volume of blood sampled via a venipuncture. The spectra contain information of all the molecules present in the blood (RBCs, hemoglobin, glucose, sodium, potassium, etc.). From these spectra, the system is able to analyze the blood and provide results in a matter of minutes, rather than hours or even, in some cases, days.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive and non-invasive blood analyte measurement | Diagnostic Test | Rapid point-of-care minimally invasive blood analyzer consisting of a spectrometer and a computer loaded with Kaligia software that controls the data acquisition and signal processing to interpret blood analyte measurement. |
| Measure | Description | Time Frame |
|---|---|---|
| Analyte validation | CLIA laboratory analyte values will be compared to device analyte readings and inform machine learning of device software learning to achieve device calibration and validation of readings. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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The research subjects subjected to the test articles used in this study will be hospital patients with doctor-prescribed blood tests as standard of care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janice Shirley, MPH | Contact | 813-919-8857 | advancedclinicalresearch@yahoo.com | |
| Fazal Fazlin | Contact | 727-234-8877 | ffazlin@kaligiabiosciences.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
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