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Refractix DSP and TS Meter-DSP Measurement Comparison

NCT05717036 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2023-02-08

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the serum plasma measurement results between the FDA cleared TS Meter-DSP and investigational Refractix DSP. Study participants will be individuals being screened for plasma donation in a plasmaphereris center. The main question the study aims to answer is whether the measurement taken on the investigational Refractix DSP device is equivalent, defined as within +/- 0.3g/100ml, of the measurement taken on the TS Meter-DSP. Participants will be asked to provide a second capillary tube of blood (\<0.085ml) from the fingerstick that is part of their routine pre-screening for plasma donation.

Conditions

  • Healthy

Interventions

DEVICE

Serum Total Protein Measurement with TS Meter-DSP and Refractix DSP

The two blood samples will be centrifuged and hematocrit measured per the plasma center's standard operating procedures. One participant sample will be dispensed onto the cleared TS Meter-DSP for a serum total protein measurement. This measurement will be used, along with other pre-screening information, to determine if the participant can donate plasma. The second participant sample will be dispensed onto the investigational Refractix DSP for a serum total protein measurement. It will be compared to the sample measurement taken on the cleared TS Meter-DSP.

Sponsors & Collaborators

  • Reichert, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2023-02-15
Completion
2023-02-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05717036 on ClinicalTrials.gov