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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bland-Altman agreement
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method) (Device)
结局指标
主要结局
Bland-Altman agreement
时间窗: 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
时间窗: Baseline
Measures linear association of quantitative results; target orrelation coefficient ≥ 0.95
Relative deviation at medical decision levels
时间窗: Baseline
Evaluates clinically acceptable error; target relative deviatio within ±15%
次要结局
- Recovery rate (spiked mixed samples vs fresh samples)(Baseline)
- Precision (Coefficient of Variation, CV)(Baseline)
研究者
Hao Sun
Principal Investigator, Clinical Associate Professor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School