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Completed

NCT Number: NCT05998109

PheCheck Feasibility Study

The goal of this feasibility study clinical trial is to compare the accuracy of PheCheck™ for the rapid quantitative detection of phenylalanine (Phe) with the gold standard (HPLC amino acid analyzer), in patients with PKU.

The main aims are:

* Evaluate the accuracy of PheCheck as compared to the gold standard * Evaluate ease of use by lay participants

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Key information

Conditions

Phenylketonurias Amino Acid Metabolism, Inborn Errors Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

About this study

The primary objective of this feasibility study is to evaluate the accuracy of the analyte concentration of PheCheck™ for the rapid, quantitative detection of phenylalanine (Phe) from capillary blood compared to the gold standard (HPLC amino acid analyzer) which quantitatively measures Phe in venous blood.

The study will enroll subjects into one study cohort. It will include patients 10 years or older, monitored for Phenylketonuria (PKU), hyperphenylalaninemia or PKU during pregnancy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 10 years of age or older
  • Being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy Signed informed consent

Exclusion criteria

  • Younger than 10 years of age
  • Not being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy
  • Lack of signed informed consent
  • Previous enrollment in the study and has completed study visit 1 and 2

Treatment and study plan

PheCheck™

Device

Quantitative, single-use, rapid test Intended for home-based self-testing and monitoring of PKU.

1 fingerstick specimen collected at each study visit

HPLC Amino Acid Analyzer

Diagnostic Test

1 venous specimen collected at each study visit

Dried Blood Spot Cards

Diagnostic Test

capillary blood specimen collected at each study visit

Primary outcomes

  1. Concentration of phenylalanine (Phe) from PheCheck as compared to HPLC amino acid analyzer

    Time frame: 6-8 weeks

    The primary outcome is the concentration of phenylalanine (Phe) from capillary blood as compared to the gold standard HPLC amino acid analyzer

Sponsors and collaborators

Lead sponsor

Lumos Diagnostics

Industry

Collaborators

  • Aptatek BioSciences, Inc

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2023
Registry last updated
Sep 15, 2025

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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