Refractix DSP and TS Meter-DSP Measurement Comparison

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Device: Serum Total Protein Measurement with TS Meter-DSP and Refractix DSP

Detailed Description

The TS Meter-DSP and investigational Refractix DSP are digital refractometers intended for the quantitative measurement of total protein in human serum or plasma. The devices are intended for use in plasma collection centers and are not for diagnostic purposes. Serum/plasma samples are taken from a successful microhematocrit assay and dispensed via pipette on to the instruments. The instruments measure the temperature compensated refractive index of the serum or plasma sample and digitally convert refractive index to an accurate total protein value. Potential donors with a total protein level of between 6.0 g/100ml and 9.0 g/100ml and that meet other pre-screening requirements are permitted to donate plasma.

These devices are FDA Class I in vitro diagnostic devices; FDA Regulation Number 862.2800 Refractometer for clinical use; with Product Code PSM, Refractometer for Donor Testing.

Participants will be those presenting for plasma donation. Ordinary pre-screening for plasma donation includes a fingerstick and the collection of one small capillary tube (<0.085ml) of blood. Participants who have consented to this study will be asked to supply a second capillary tube (<0.085ml) of blood for the clinical trial. The two samples will be centrifuged and hematocrit measured per the plasma center's standard operating procedures. One sample will be dispensed onto the TS Meter-DSP for total protein measurement. This measurement will be used to determine the individual's eligibility to donate plasma. The second sample will be dispensed on to the investigational Refractix DSP for total protein measurement. The measurements from both devices will be recorded on the Case Report Form. The study requires (36) participants with total protein measurements between 6.0 g/100ml and 9.0 g/100ml.

The primary analysis of data will include:

1. a Grubb's test for outlying paired difference values will be performed. If outliers are detected and a plausible non-device failure mechanism can be identified (eg, operator or data entry error), the values will be excluded from the acceptance criterion calculations;
2. an alpha=0.05 level equivalence test with an equivalence interval of +/- 0.3 g/100ml will be performed using the TOST (Two One Sample Test) procedure. A paired t-test 90% confidence interval for the difference in paired sample measurements will be constructed and reported; and
3. calculate the percentage of measurement pairs falling outside of the +/-0.3 tolerance.

• Study Type: Observational
• Enrollment (Anticipated): 36

Contacts and Locations

• Study Contact: Name: Linton Davis; Phone Number: 754-336-1503; Email: ldavis@hemarus-plasma.com
• Study Contact Backup: Name: Melvyn W Kramer, MD; Phone Number: 978-333-1997; Email: melvynkramer@aol.com

Study Locations

• United States
  • Florida
    • Lauderhill, Florida, United States, 33313
      • Hemarus Plasma
      • Contact: Linton W Davis; Phone Number: 754-336-1503; Email: ldavis@hemarus-plasma.com
      • Contact: Melvyn W Kramer, MD; Phone Number: 9783331997; Email: melvynkramer@aol.com
      • Principal Investigator: Melvyn W Kramer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Reichert, Inc.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 13, 2023
• Primary Completion (ANTICIPATED): February 15, 2023
• Study Completion (ANTICIPATED): February 15, 2023

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: serum total protein
• Other Study ID Numbers: 13910000-TPR-30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No