Diquat PoisoningNCT07399574
Diagnostic Accuracy of A Diquat Quantitative Detection Kit and A Portable Mass Spectrometry System for Quantifying Diquat Concentrations in Human Blood Samples
An observational study of Diquat Poisoning, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diquat Poisoning
- What is being tested?
- Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method)
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
- Conditions
- Diquat Poisoning
- Being tested
- Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method) | |
| 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. Receives: Device: Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method) | |
| 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. Receives: Device: Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method) | |
| 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. Receives: Device: Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bland-Altman agreement
Assesses agreement and bias between the two methods; requires most data points within preset LOA
Measured: Baseline
Correlation coefficient between portable MS and LC-MS/MS
Measures linear association of quantitative results; target orrelation coefficient ≥ 0.95
Measured: Baseline
Relative deviation at medical decision levels
Evaluates clinically acceptable error; target relative deviatio within ±15%
Measured: Baseline
Secondary outcomes (2)
Recovery rate (spiked mixed samples vs fresh samples)
Target recovery 85%-115%
Measured: Baseline
Precision (Coefficient of Variation, CV)
Within-run CV ≤ 10%; between-run CV ≤ 15%
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Jul 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diquat PoisoningStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Sun, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399574
- Sponsor's protocol ID
- 2025-1207-02
- Status last verified
- Oct 2026
- First submitted
- 26 Jan 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07399574
- Acronym / sponsor ID
- 2025-1207-02
- Conditions
- Diquat Poisoning
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diquat Poisoning Group (Low Concentration) | – | Device: Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method)Participants presenting to the emergency department with clinically diagnosed acute diquat poisoning whose diquat concentration is classified into the low concentration stratum. |
| Diquat Poisoning Group (Medium Concentration) | – | Device: Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method)Participants presenting to the emergency department with clinically diagnosed acute diquat poisoning whose diquat concentration is classified into the medium concentration stratum. |
| Diquat Poisoning Group (High Concentration) | – | Device: Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method)Participants presenting to the emergency department with clinically diagnosed acute diquat poisoning whose diquat concentration is classified into the high concentration stratum. |
| Non-Diquat Poisoning Group (Negative Control) | – | Device: Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method)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 | Device | Diquat Poisoning Group (High Concentration), Diquat Poisoning Group (Low Concentration), Diquat Poisoning Group (Medium Concentration), Non-Diquat Poisoning Group (Negative Control) |
Primary outcome
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%
2 secondary outcomes
Recovery rate (spiked mixed samples vs fresh samples)
Time frame: Baseline
Precision (Coefficient of Variation, CV)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diquat Poisoning, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bland-Altman agreement (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.