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In low-resource areas of the world, anemia screening relies on analyzing a blood sample and is generally carried out in health facilities. Current anemia screening approaches have not yielded satisfactory results due to critical limitations including lack of a) reliable access to laboratory facilities, b) reliable non-invasive out-of-hospital screening tools for community health-workers, c) integration of anemia data across health systems and d) distinction between hemolytic and nutritional causes. Currently available non-invasive tools have unacceptably low accuracy and cannot distinguish between nutritional and hemolytic etiologies.
Prototype Anemia Diagnostic Assistant (ADA)
We have developed a prototype Anemia Diagnostic Assistant for non-invasive, simultaneous detection of two markers of anemia, blood hemoglobin and the End-Tidal carbon monoxide levels. The device comprises an optical sensor module and ETCO breath sampling module.
The unique and significant advantage of the instrument is its ability to detect, independently, two orthogonal variables that are required for differential diagnosis of the nutritional and hemolytic anemia:
The objective of this study is to determine the hemoglobin and ETCO concentration in healthy volunteers using the prototype device and compare the results with the hemoglobin and ETCO concentrations obtained using standard of care devices and the CoSense system for the (ETCO measurement).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy adults | Participants will be adults aged 18-70, male or female |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anemia Diagnostic Assistant (ADA) | Diagnostic Test | The Anemia Diagnostic Assistant is non-invasive and simultaneously detects two markers of anemia, blood hemoglobin and the End-Tidal carbon monoxide levels. The device comprises an optical sensor module and ETCO breath sampling module. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in ADA hemoglobin values compared to serum hemoglobin values | Each participant will have their hemoglobin measured using the ADA and blood analysis. These values will then be compared to measure the difference between the ADA values and the serum values. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hemolytic anemia | The ETCO is a well established measure of hemolysis. The study will evaluate the number of positive readings and individual participants who have a positive measure will be referred for further hospital testing. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be recruited from the University of Utah campus. Potential participants can be students or staff.
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| Name | Affiliation | Role |
|---|---|---|
| Allison Judkins, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112 | United States |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Serum hemoglobin | Diagnostic Test | Venous blood will be drawn on the same day as the ADA was applied and sent to the hospital lab for hemoglobin analysis. |
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