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Completed

NCT Number: NCT04146246

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

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.

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Key information

Conditions

G6PD Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities G6PD Deficiency Genetic Diseases, Inborn Glucosephosphate Dehydrogenase Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

35 week–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke Health, Durham, North Carolina, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

G6PD assay

Diagnostic Test

A test for G6PD deficiency.

Primary outcomes

  1. G6PD enzymatic activity in adults and neonates

    Time frame: 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 outcomes

  1. Point of care/near patient results and clinical laboratory results

    Time frame: 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.

  2. Arterial/venous whole blood results and tissue capillary test results

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Baebies, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 31, 2019
Registry last updated
Nov 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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