G6PD, G6PD Deficiency
Conditions
Keywords
G6PD, Neonate
Brief 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.
Interventions
DIAGNOSTIC_TESTG6PD assay
A test for G6PD deficiency.
Sponsors
Baebies, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Weeks to 100 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| G6PD enzymatic activity in adults and neonates | 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
| Measure | Time frame | Description |
|---|---|---|
| Point of care/near patient results and clinical laboratory results | 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 | 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. |
Countries
United States
Outcome results
None listed