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

NCT05450523 | Completed

• 1 other identifier: HT1.0
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Dialysis-associated Peritonitis

Outcome Measures

Primary Outcomes (2)

• Assessment reagent test results and clinical reference standard statistics

  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.

  8 months

• Statistical analysis of non-professional self-testing test

  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.

  8 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients treated with peritoneal dialysis due to kidney disease, including those with confirmed peritonitis and those without peritonitis.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Qingdao HIGHTOP Biotech Co., Ltd.: lead

Study Sites (1)

The first affiliated hosital of Nangchang university

Nanchang, Jiangxi, China

Location

Study Officials

• Qinkai Chen, Chief physician

  The first affiliated hosital of Nangchang university

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 8, 2022
• Study Start: December 28, 2021
• Primary Completion: September 7, 2022
• Study Completion: September 7, 2022
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

CN (1)