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

N/ANot Yet RecruitingNCT07399574

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School60 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Diquat Poisoning

Interventions

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Bland-Altman agreement

Assesses agreement and bias between the two methods; requires most data points within preset LOA

Time frame: Baseline

Correlation coefficient between portable MS and LC-MS/MS

Measures linear association of quantitative results; target orrelation coefficient ≥ 0.95

Time frame: Baseline

Relative deviation at medical decision levels

Evaluates clinically acceptable error; target relative deviatio within ±15%

Time frame: Baseline

Secondary Outcomes

Recovery rate (spiked mixed samples vs fresh samples)

Target recovery 85%-115%

Time frame: Baseline

Precision (Coefficient of Variation, CV)

Within-run CV ≤ 10%; between-run CV ≤ 15%

Time frame: Baseline

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts