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Diagnostic Accuracy of A Diquat Quantitative Detection Kit and A Portable Mass Spectrometry System for Quantifying Diquat Concentrations in Human Blood Samples
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Summary
This is an observational, non-interventional diagnostic accuracy study designed to evaluate a diquat quantitative detection kit (ambient ionization mass spectrometry method) and a portable mass spectrometry analysis system for measuring diquat concentrations in human blood samples (whole blood/plasma), using LC-MS/MS as the clinical gold standard for comparison.
Official title: Accuracy, Safety, and Clinical Performance of a Diquat Quantitative Detection Kit (In-Situ Ionization Mass Spectrometry) and a Portable Mass Spectrometry System for Quantifying Diquat Concentrations in Human Blood Samples (Whole Blood/Plasma)
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2026-03-01
Completion Date
2028-12-31
Last Updated
2026-02-10
Healthy Volunteers
No
Conditions
Interventions
Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method)
The portable mass spectrometry analysis system is an in vitro diagnostic device used with a diquat quantitative detection kit based on an in-situ/ambient ionization mass spectrometry method to quantify diquat concentrations in human blood samples. Whole blood specimens collected in routine clinical care will be analyzed using this device, and the quantitative results will be compared against those obtained using the reference standard method, liquid chromatography-tandem mass spectrometry (LC-MS/MS), to evaluate analytical accuracy and agreement. Each specimen will be tested repeatedly (three measurements per sample), and the mean value will be used for statistical analysis. The study is observational and non-interventional, and test results generated by the portable mass spectrometry system are used for research evaluation purposes and do not alter routine clinical diagnosis or treatment decisions
Locations (1)
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China