Validation of Drug Assays in Various Biological Matrices

Recruiting

• Conditions: Infection

• Registration Number: NCT02283112
• Lead Sponsor: Helen Reynolds

Brief Summary

This study aims to ensure that assays that measure drug concentrations are accurate and precise in different matrices when quantified using high performance liquid chromatography -tandem mass spectrometry (HPLC-MS/MS). The study involves collecting samples of various bodily fluids to quantify antimicrobials, antivirals, oral contraceptives and erectile dysfunction agents. Samples will also be obtained from individuals not receiving these medications for quality control purposes.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• > 18 years of age

Exclusion Criteria

• Unable to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure drug concentrations using high performance liquid chromatography -tandem mass spectrometry (HPLC-MS/MS) (accuracy and precision of assays that measure drug concentrations)	Follow up up to 5 years	Assay validation

Trial Locations

Locations (1)

Royal Liverpool & Broadgreen Univeristy Hospitals NHS Trust; 🇬🇧 Liverpool, United Kingdom