Refractix DSP and TS Meter-DSP Measurement Comparison

NCT05717036 | Unknown FDA Device

• 1 other identifier: 13910000-TPR-30
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

serum total protein

Outcome Measures

Primary Outcomes (1)

• Serum Total Protein Measurement Comparison

  The purpose of this study is to show the investigational Refractix DSP refractometer yields equivalent measurement results to the predicate device TS Meter-DSP through comparison testing using human plasma samples.

  Samples will be collected over one or two days at the plasma center. Data analysis by sponsor will be completed within 8 weeks.

Study Arms (1)

TS Meter-DSP Measurement and Refractix DSP Measurement

The study will involve blood serum samples from (36) participants. Participants will be those presenting at a plasma collection center for routine plasma donation. Ordinary pre-screening for plasma donation includes a fingerstick and the collection of one small capillary tube (\<0.085ml) of blood. Participants will be asked to provide a second capillary tube (\<0.085ml) of blood from this fingerstick.

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

Interventions

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

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.

TS Meter-DSP Measurement and Refractix DSP Measurement

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be individuals presenting at a plasma collection center for plasma donation.

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.

Sponsors & Collaborators

• Reichert, Inc.: lead

Study Sites (1)

Hemarus Plasma

Lauderhill, Florida, 33313, United States

Location

Central Study Contacts

Linton Davis

CONTACT

754-336-1503; ldavis@hemarus-plasma.com

Melvyn W Kramer, MD

CONTACT

978-333-1997; melvynkramer@aol.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 8, 2023
• Study Start: February 13, 2023
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)