Comparative Evaluation of the FINDER Instrument and FINDER G6PD Cartridge in Adults and Neonates

Comparative Evaluation of the FINDERTM Instrument and FINDERTM G6PD Cartridge in Adults and Neonates

A prospective clinical study to compare the clinical performance of the FINDER™ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations.

Study Overview

• Status: Completed
• Conditions: G6PD Deficiency; G6PD
• Intervention / Treatment: Diagnostic test: G6PD assay

Detailed Description

A prospective clinical study to compare the clinical performance of the FINDER™ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations. Neonate and adult subjects will be recruited from 3 clinical sites. Neonate samples will be collected as heel prick unless an in dwelling line is already in place at which point a venous or arterial/umbilical sample will be collected. Adult samples will be collected as venous/arterial samples and finger stick samples. Samples will be tested at the point of care/near patient and in the clinical laboratory using the FINDER Instrument and G6PD assay on a digital microfluidic platform. Samples will also be sent to a third party CLIA laboratory for test using an FDA 510(k) cleared instrument/reagent combination for G6PD.

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Health
    • Raleigh, North Carolina, United States, 27610
      • Wake Med
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center Rainbow Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults who are at least 18 years of age or older. Neonates who are at least 35 gestational weeks old, recruited from the well baby nursery or the NICU.

Description

Inclusion Criteria:

• Neonates aged >35 gestational weeks or older.
• Adult subjects who are age 18 and older.
• Adult subjects who weigh at least 110 pounds.
• All ethnicities.
• Male and female subjects.

Exclusion Criteria:

• Adult subjects who weigh less than 110 pounds.
• Subjects with anemia for which an attending physician will not authorize a blood draw.
• Subjects who have received a blood transfusion.
• Subjects who are pregnant.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult; Adults aged 18 years or older. Collect whole blood sample via venous/arterial puncture and, where possible, finger stick.	Diagnostic test: G6PD assay; A test for G6PD deficiency.
Neonate; Neonates gestational age >35 weeks or older. Collect whole blood sample via heel prick or, where an in dwelling line already exists, via arterial/umbilical draw.	Diagnostic test: G6PD assay; A test for G6PD deficiency.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
G6PD enzymatic activity in adults and neonates	G6PD enzymatic activity in the FINDER System for adults and neonates compared to the G6PD activity tested using a known FDA cleared assay/instrument combination	Immediately following a blood draw.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Point of care/near patient results and clinical laboratory results	Characterization of the performance of the FINDER device when used at a POC/near patient location and when used in a clinical laboratory location.	Immediately following a blood draw.
Arterial/venous whole blood results and tissue capillary test results	Characterization of the performance of the FINDER G6PD assay when tested with blood from a venipuncture or arterial puncture, including umbilical catheter access, and where possible, performance will be evaluated when tested with blood from tissue puncture capillary samples.	Immediately following a blood draw.

Collaborators and Investigators

• Sponsor: Baebies, Inc.
• Investigators: Study Director: Rama Sista, PhD, Director Product Development

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2019
• Primary Completion (Actual): March 13, 2020
• Study Completion (Actual): March 13, 2020

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): November 23, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Neonate; G6PD
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Glucosephosphate Dehydrogenase Deficiency
• Other Study ID Numbers: CSPROJ00004001

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