PheCheck Feasibility Study

Lumos Diagnostics30 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Phenylketonurias

Interventions

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 AnalyzerDIAGNOSTIC_TEST

1 venous specimen collected at each study visit

Dried Blood Spot CardsDIAGNOSTIC_TEST

capillary blood specimen collected at each study visit

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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

Locations (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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

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

Time frame: 6-8 weeks

Data from ClinicalTrials.gov

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