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

Peritoneal Dialysis-associated Peritonitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05450523
• Other study ID #: HT1.0
• Status: Completed
• Start date: December 28, 2021
• Est. completion date: September 7, 2022

Study information

• Verified date: March 2023
• Source: Qingdao HIGHTOP Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: September 7, 2022
• Est. primary completion date: September 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Peritoneal Dialysis-associated Peritonitis
• Peritonitis

Locations

Country	Name	City	State
China	The first affiliated hosital of Nangchang university	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao HIGHTOP Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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