Diagnostic Accuracy of A Diquat Quantitative Detection Kit and A Portable Mass Spectrometry System for Quantifying Diquat Concentrations in Human Blood Samples

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diquat Poisoning
• Intervention / Treatment: Device: Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method)

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Hap Sun, MD, PhD; Phone Number: 8613584017821; Email: haosun_6@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital
      • Contact: Hao Sun, MD, PhD; Phone Number: 8613584017821; Email: haosun_6@163.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from patients presenting to the emergency department during the study period. The study population includes individuals with suspected or clinically diagnosed acute diquat poisoning, stratified into low, medium, and high concentration groups (15 participants per group), as well as a negative control group consisting of non-diquat-poisoning patients (15 participants), for a total enrollment of 60 participants.

Description

Inclusion Criteria:

1. Patients with suspected or clinically diagnosed acute diquat poisoning, providing whole blood and/or plasma samples, including qualified residual specimens retained after prior clinical testing when available.
2. The participant or their legally authorized representative can fully understand the study purpose and procedures, voluntarily agrees to participate, and is willing and able to comply with the study requirements.
3. Sample collection is performed according to routine clinical standards, with no apparent ethical concerns related to sample acquisition.

Exclusion Criteria:

1. Abnormal sample appearance, such as visible flocculent material or other gross abnormalities.
2. The participant is unable to provide a specimen, or the specimen does not meet testing requirements.
3. Any participant considered inappropriate for inclusion by the investigator.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diquat Poisoning Group (Low Concentration); Participants presenting to the emergency department with clinically diagnosed acute diquat poisoning whose diquat concentration is classified into the low concentration stratum.	Device: 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
Diquat Poisoning Group (Medium Concentration); Participants presenting to the emergency department with clinically diagnosed acute diquat poisoning whose diquat concentration is classified into the medium concentration stratum.	Device: 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
Diquat Poisoning Group (High Concentration); Participants presenting to the emergency department with clinically diagnosed acute diquat poisoning whose diquat concentration is classified into the high concentration stratum.	Device: 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
Non-Diquat Poisoning Group (Negative Control); Participants presenting to the emergency department who are not diagnosed with acute diquat poisoning will be enrolled as negative controls. Their blood samples will be tested in parallel to support evaluation of method performance and to confirm negative results in non-diquat cases.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bland-Altman agreement	Assesses agreement and bias between the two methods; requires most data points within preset LOA	Baseline
Correlation coefficient between portable MS and LC-MS/MS	Measures linear association of quantitative results; target orrelation coefficient ≥ 0.95	Baseline
Relative deviation at medical decision levels	Evaluates clinically acceptable error; target relative deviatio within ±15%	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery rate (spiked mixed samples vs fresh samples)	Target recovery 85%-115%	Baseline
Precision (Coefficient of Variation, CV)	Within-run CV ≤ 10%; between-run CV ≤ 15%	Baseline

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-1207-02