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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method) | Device | 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 |
| 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 |
| 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% |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hap Sun, MD, PhD | Contact | 8613584017821 | haosun_6@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
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Venous blood specimens will be collected from participants, including whole blood and plasma. At least 2 mL of venous blood will be drawn into anticoagulant tubes (heparin sodium or EDTA). Plasma will be separated by centrifugation (approximately 3000×g for 10-15 minutes) when needed. Samples may include qualified residual specimens remaining after routine clinical testing. Fresh specimens will be tested immediately when feasible, or stored at 2-6°C and analyzed within 24 hours, while a subset of samples may be stored at -80°C for frozen-sample comparisons under routine clinical storage conditions.
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| Baseline |