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Completed

NCT Number: NCT05450523

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

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.

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Key information

Conditions

Peritoneal Dialysis-associated Peritonitis

Sex eligibility

All sexes

Study type

Observational

Primary location

The first affiliated hosital of Nangchang university

Nanchang, Jiangxi, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Primary outcomes

  1. Assessment reagent test results and clinical reference standard statistics

    Time frame: 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.

  2. Statistical analysis of non-professional self-testing test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Qingdao HIGHTOP Biotech Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 8, 2022
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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