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)
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Bland-Altman agreement
Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •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.
- •Sample collection is performed according to routine clinical standards, with no apparent ethical concerns related to sample acquisition.
Exclusion Criteria
- •Abnormal sample appearance, such as visible flocculent material or other gross abnormalities.
- •The participant is unable to provide a specimen, or the specimen does not meet testing requirements.
- •Any participant considered inappropriate for inclusion by the investigator.
Arms & Interventions
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.
Intervention: Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method) (Device)
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.
Intervention: Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method) (Device)
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.
Intervention: Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method) (Device)
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.
Intervention: Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method) (Device)
Outcomes
Primary Outcomes
Bland-Altman agreement
Time Frame: Baseline
Assesses agreement and bias between the two methods; requires most data points within preset LOA
Correlation coefficient between portable MS and LC-MS/MS
Time Frame: Baseline
Measures linear association of quantitative results; target orrelation coefficient ≥ 0.95
Relative deviation at medical decision levels
Time Frame: Baseline
Evaluates clinically acceptable error; target relative deviatio within ±15%
Secondary Outcomes
- Recovery rate (spiked mixed samples vs fresh samples)(Baseline)
- Precision (Coefficient of Variation, CV)(Baseline)
Investigators
Hao Sun
Principal Investigator, Clinical Associate Professor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School