Pilot Feasibility Study of a Novel Non-invasive Device for Diagnosis of Anemia

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:

1. Hemoglobin concentration using a non-invasive diffuse reflectance spectroscopy. Using high-fidelity, 11 wave-length spectral sensor, the device will provide optical quantification of hemoglobin levels. Optical hemoglobin sensing using diffused reflectance spectroscopy is well known, however; using traditional spectrophotometry instrumentation is very costly and thus impractical for this project. As a solution, we propose to use a validated commercially-available high accuracy 11-wavelength sensor within the visual and near-infrared (IR) range of the spectrum. The 11-wavelength spectrum will allow for sufficient accuracy in measuring the reflectance AND transmittance at isosbestic wavelengths on hemoglobin extinction curve as well as to compensate for the presence of melanin, which is a major interferant in optical determination of hemoglobin concentration. [9] The sensor was originally designed to collect data on the earlobe and/or the fingertip. Additional iterations include a sensor that straps around the wrist (similar to a smartwatch). Both versions of the device may be used in the study, and both feature standard USB or Bluetooth connectivity to ubiquitous mobile Android an iOS-based mobile platform .
2. End-tidal carbon monoxide. Using a non-invasive probe placed in proximity to the nostrils, the device will measure ETCO as a proxy measure of hemolysis. ETCO measurement as a measure for the presence of hemolysis is well documented in the medical literature and is commonly used in newborns units as a screening method for the presence of hemolysis [7,8,10]. A positive finding (presence of elevated levels of ETCO) will then prompt a referral for further hospital testing.

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).

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Diagnostic test: Anemia Diagnostic Assistant (ADA); Diagnostic test: Serum hemoglobin

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Participants will be recruited from the University of Utah campus. Potential participants can be students or staff.

Description

Inclusion Criteria:

• Healthy adult

Exclusion Criteria:

• Immunocompromised subjects
• Patients with known hemolytic disease, anemia, or other chronic illness
• Patients who do not provide consent.
• Those who are students or reporting staff of investigators will be excluded.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Healthy adults; Participants will be adults aged 18-70, male or female

Diagnostic test: Anemia Diagnostic Assistant (ADA); 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.; Diagnostic test: Serum hemoglobin; Venous blood will be drawn on the same day as the ADA was applied and sent to the hospital lab for hemoglobin analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Allison Judkins, MD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Actual): December 12, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: non-invasive detection
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Chrysarobin
• Other Study ID Numbers: 00145719

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No