Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Baebies, Inc.
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.
Age
0–100
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Comparative Evaluation of the FINDER Instrument and FINDER G6PD Cartridge in Adults and Neonates
