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

Overview

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.

Full Title of Study: “Comparative Evaluation of the FINDERTM Instrument and FINDERTM G6PD Cartridge in Adults and Neonates”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 30, 2020

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.

Interventions

  • Diagnostic Test: G6PD assay
    • A test for G6PD deficiency.

Arms, Groups and Cohorts

  • Adult
    • Adults aged 18 years or older. Collect whole blood sample via venous/arterial puncture and, where possible, finger stick.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • G6PD enzymatic activity in adults and neonates
    • Time Frame: Immediately following a blood draw.
    • 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

Secondary Measures

  • Point of care/near patient results and clinical laboratory results
    • Time Frame: Immediately following a blood draw.
    • Characterization of the performance of the FINDER device when used at a POC/near patient location and when used in a clinical laboratory location.
  • Arterial/venous whole blood results and tissue capillary test results
    • Time Frame: Immediately following a blood draw.
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 35 Weeks

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Baebies, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Rama Sista, PhD, Study Director, Director Product Development
  • Overall Contact(s)
    • Rama Sista, PhD, 850-559-5082, rsista@baebies.com

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