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Purpose

The goal of this observational study is to evaluate the performance of the PheCheck™ test for the rapid detection of phenylalanine (Phe) from a fingerstick sample, in patients 1 year or older with phenylketonuria (PKU) or hyperphenylalaninemia. The main objective is comparing the concentration of phenylalanine (Phe) in capillary blood with the reference method (DBS).

Condition

Eligibility

Eligible Ages
Over 1 Year
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 1 year or older and able to have a fingerstick blood collected - Being monitored for Phenylketonuria (classical PKU, mild PKU, variant PKU, or hyperphenylalaninemia) - Signed informed consent

Exclusion Criteria

  • Previous enrollment in the study and has completed 3 study visits - Inability to read and understand instructions

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Patients with Phenylketonuria or Hyperphenylalaninemia Device: PheCheck Test Description: Quantitative, single-use, rapid test Intended for home-based self-testing and monitoring of PKU. 1 fingerstick specimen collected at each study visit Comparator: Dried Blood Spot Cards. 1 fingerstick specimen collected at each study visit
  • 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 Sample read using an electronic reader. Results available within 1 hour
  • Diagnostic Test: Dried Blood Spot Cards.
    Laboratory-based reference method 1 fingerstick specimen at each study visit to collect 5 samples to fill 5 spots on the card. Card sent to a laboratory, results available within 72 hours

Recruiting Locations

Lurie Children's Hospital
Chicago, Illinois 60611
Contact:
Steven J Eichinger
(312) 227-8952
seichinger@luriechildrens.org

More Details

Status
Recruiting
Sponsor
Aptatek BioSciences, Inc

Study Contact

Catalina Suarez-Cuervo, MD
727-776-5880
Clinicalstudies@lumosdiagnostics.com

Detailed Description

The primary objective of this study is to evaluate the performance of the PheCheck™ test for the rapid, quantitative detection of phenylalanine (Phe) direct from a capillary (fingerstick) sample. Results will be compared to reference testing from Dried Blood Spot Cards (DBS). The PheCheck™ test performs a quantitative determination of phenylalanine in a self-collected or parent/guardian-collected capillary blood sample. The analysis will evaluate the performance of the analyte concentration of phenylalanine in prospectively collected samples self-collected and tested by patients with PKU, measured by the PheCheck™ test as compared to the standard of care DBS testing performed by a reference lab

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.