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

Baebies, Inc.119 enrolled

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.

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

119

Conditions

G6PD G6PD Deficiency

Interventions

G6PD assayDIAGNOSTIC_TEST

A test for G6PD deficiency.

Eligibility

Sex: ALLMin age: 35 WeeksMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Duke Health

Durham, North Carolina, United States

Wake Med

Raleigh, North Carolina, United States

University Hospitals Cleveland Medical Center Rainbow Children's Hospital

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: Immediately following a blood draw.

Secondary Outcomes

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.

Time frame: 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.

Time frame: Immediately following a blood draw.

Data from ClinicalTrials.gov

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