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

Baebies

Status: Completed

Conditions: G6PD Deficiency; G6PD

Treatments: Diagnostic Test: G6PD assay

Study type: Observational

Funder types: Industry

Identifiers

NCT04146246

CSPROJ00004001

Details and patient eligibility

About

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 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.

Enrollment: 119 patients

Sex: All

Ages: 35 weeks to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

119 participants in 2 patient groups

Adult

Description:

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

Treatment:

Diagnostic Test: G6PD assay

Neonate

Description:

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.

Treatment:

Diagnostic Test: G6PD assay