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

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

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.

Study Overview

• Status: Completed
• Conditions: Peritoneal Dialysis-associated Peritonitis

• Study Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China
      • The first affiliated hosital of Nangchang university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Qingdao HIGHTOP Biotech Co., Ltd.
• Investigators: Study Chair: Qinkai Chen, Chief physician, The first affiliated hosital of Nangchang university

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2021
• Primary Completion (Actual): September 7, 2022
• Study Completion (Actual): September 7, 2022

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 18, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Intraabdominal Infections; Peritonitis
• Other Study ID Numbers: HT1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No