Performance Evaluation Study of the reagent Total Bile Acids FS in humane stool samples

• Conditions: K50; K58; K90; Crohn disease [regional enteritis]; Irritable bowel syndrome; Intestinal malabsorption

• Registration Number: DRKS00031283
• Lead Sponsor: DiaSys Diagnostic Systems GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-24
• Study Completion: 2023-08-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Physician's request to determine bile acids in stool

Exclusion Criteria

Hospitalization

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantitative measurements through the Total Bile Acids FS reagent on clinical chemistry analyzers and determination of the recovery and the accuracy against LC-MS/MS referenced liquid individual Bile Acids Standards

Secondary Outcome Measures

Name	Time	Method
not defined