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

Study Overview
=================
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.

Official Title
-----------------
Comparative Evaluation of the FINDERTM Instrument and FINDERTM G6PD Cartridge in Adults and Neonates

Conditions
-----------------
G6PD, G6PD Deficiency

Intervention / Treatment
-----------------
* Diagnostic Test: G6PD assay


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 35 Weeks
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult<br>Adults aged 18 years or older. Collect whole blood sample via venous/arterial puncture and, where possible, finger stick. | Diagnostic Test: G6PD assay<br>* A test for G6PD deficiency.<br>|
| Neonate<br>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. | Diagnostic Test: G6PD assay<br>* A test for G6PD deficiency.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Immediately following a blood draw. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Immediately following a blood draw. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
G6PD, Neonate