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

Qingdao HIGHTOP Biotech Co., Ltd.220 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

220

Conditions

Peritoneal Dialysis-associated Peritonitis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

The first affiliated hosital of Nangchang university

Nanchang, Jiangxi, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 8 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.