Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07399574

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Diquat Poisoning

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Bland-Altman agreement

    Time frame: Baseline

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

  2. Correlation coefficient between portable MS and LC-MS/MS

    Time frame: Baseline

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

  3. Relative deviation at medical decision levels

    Time frame: Baseline

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

Secondary outcomes

  1. Recovery rate (spiked mixed samples vs fresh samples)

    Time frame: Baseline

    Target recovery 85%-115%

  2. Precision (Coefficient of Variation, CV)

    Time frame: Baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hap Sun, MD, PhD

CONTACT

[email protected]

8613584017821

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 10, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.