Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) Clinical Trial Protocol

Completed

• Conditions: Peritoneal Dialysis-associated Peritonitis

• Registration Number: NCT05450523
• Lead Sponsor: Qingdao HIGHTOP Biotech Co., Ltd.

Brief Summary

According to the requirements of the "Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents", the first registered product (hereinafter referred to as the assessment reagent) - Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) was tested in clinical institutions. ) for clinical validation trials. Prove that the clinical performance of the assessment reagent meets the requirements of the intended use.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-28
• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-08
• Primary Completion: 2022-09-07
• Study Completion: 2022-09-07
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-18
• Last Update Posted: 2023-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Patients treated with peritoneal dialysis due to kidney disease, including those with confirmed peritonitis and those without peritonitis. There are no age or gender requirements, and informed consent is required.

Exclusion Criteria

1. Patients who have been treated with antibiotics for peritonitis before taking the sample.
2. Incomplete information, including: sample ID number, gender, age, department, clinical diagnosis, sample type, and sampling date.
3. The sample size is insufficient.
4. Repeated cases.
5. The samples whose permeate is red in visual inspection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment reagent test results and clinical reference standard statistics	8 months	The peritoneal dialysis effluent collected from the subjects was tested blindly with the assessment reagents, and the test results were compared with the clinical reference standards. By evaluating the clinical sensitivity and specificity of the assessment reagents, the feasibility of clinical application of the assessment reagents was evaluated.
Statistical analysis of non-professional self-testing test	8 months	There is no need to train non-professionals. After reading the instructions and labels, non-professionals can evaluate their ability to understand key information such as instructions and packaging labels through questionnaires; Research, comparison of test results of different forms of reagents, and comparison with professional test results to evaluate their operational capabilities.

Trial Locations

Locations (1)

The first affiliated hosital of Nangchang university; 🇨🇳 Nanchang, Jiangxi, China