Refractix DSP and TS Meter-DSP Measurement Comparison

Status unconfirmed

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT05717036

Run by

Reichert, Inc.

People needed

36

Starts

2023-02-13

Expected to finish

2023-02-15

Last updated by the study team

2023-02-08

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects must be between the ages of 18 and 90 years old
• Subjects must be able and willing to provide signed informed consent
• Subjects must be able to follow study instructions

You may not qualify if…

• Insufficient amount of plasma sample for use on either device in the study.
• Plasma samples of with total protein measurements outside of the 6.0 g/100ml to 9.0 g/100ml range will be excluded from the data analysis.

Where it is running

• Hemarus Plasma — Lauderhill, Florida, United States

Full record on ClinicalTrials.gov

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