NCT04146246

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 119 (actual)
• Sponsor: Baebies, Inc. · Industry
• Sex: All
• Age: 35 Weeks – 100 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• G6PD
• G6PD Deficiency

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	G6PD assay	A test for G6PD deficiency.

Timeline

• Start date: 2019-11-11
• Primary completion: 2020-03-13
• Completion: 2020-03-13
• First posted: 2019-10-31
• Last updated: 2020-11-23

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study