NCT05998109

PheCheck Feasibility Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Lumos Diagnostics · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Phenylketonurias

Interventions

Type	Name	Description
DEVICE	PheCheck™	Quantitative, single-use, rapid test Intended for home-based self-testing and monitoring of PKU. 1 fingerstick specimen collected at each study visit
DIAGNOSTIC_TEST	HPLC Amino Acid Analyzer	1 venous specimen collected at each study visit
DIAGNOSTIC_TEST	Dried Blood Spot Cards	capillary blood specimen collected at each study visit

Timeline

• Start date: 2023-12-15
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2023-08-18
• Last updated: 2025-09-15

Locations

1 site across 1 country: United States