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A prospective clinical study to compare the clinical performance of the FINDERâ„¢ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations.
A prospective clinical study to compare the clinical performance of the FINDERâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult | Adults aged 18 years or older. Collect whole blood sample via venous/arterial puncture and, where possible, finger stick. |
| |
| Neonate | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G6PD assay | Diagnostic Test | A test for G6PD deficiency. |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adults who are at least 18 years of age or older. Neonates who are at least 35 gestational weeks old, recruited from the well baby nursery or the NICU.
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| Name | Affiliation | Role |
|---|---|---|
| Rama Sista, PhD | Director Product Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Health | Durham | North Carolina | 27705 | United States | ||
| Wake Med |
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| ID | Term |
|---|---|
| D005955 | Glucosephosphate Dehydrogenase Deficiency |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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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. |
| Raleigh |
| North Carolina |
| 27610 |
| United States |
| University Hospitals Cleveland Medical Center Rainbow Children's Hospital | Cleveland | Ohio | 44106 | United States |
| D006425 |
| Hemic and Lymphatic Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |