News update: A new portable diquat detection system with a quantitative kit is entering the clinical trial stage to quantify diquat in human blood. The study, led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, is not yet recruiting as of February 11, 2026. This device based approach may impact clinicians managing diquat poisoning and regulators evaluating novel point of care testing options.
As of February 11 2026 the study is described as not yet recruiting and is focused on evaluating a portable mass spectrometry analysis system paired with the Diquat Quantitative Detection Kit for blood analysis using in situ ambient ionization mass spectrometry. The work aims to quantify diquat concentrations in human blood samples and to establish analytic performance that would support future regulatory submission. The sponsor is The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School and the trial status has not advanced to recruitment yet.
What changed in diquat detection research?
In recent years there has been focus on measuring diquat in blood using portable analysis tools. The current study describes a portable Mass Spectrometry Analysis System for Quantitative Diquat Detection paired with the Diquat Quantitative Detection Kit. The approach uses an in situ ambient ionization method to quantify diquat concentrations in human blood samples. The sponsor is The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School and the trial is not yet recruiting as of February 11 2026.
What devices are involved?
The intervention centers on a portable Mass Spectrometry Analysis System for Quantitative Diquat Detection used with the Diquat Quantitative Detection Kit. The method relies on in situ ambient ionization mass spectrometry to obtain quantitative diquat measurements in human blood samples.
What are regulatory implications for this device?
As a not yet recruiting program the work is in early stages. The sponsor is a hospital affiliated with Nanjing University Medical School. Regulatory considerations will focus on analytical performance safety and the ability to support an intended use statement consistent with medical device regulations. The description provided by the sponsor implies that evidence from the trial will inform potential regulatory submissions.
What safety considerations apply?
Because no results are published yet safety data are not available. The emphasis is on the system’s analytical reliability and measurement accuracy. Regulatory evaluation would require risk assessment and demonstration of safe operation of the portable system in clinical environments and robust data handling.
What is the timeline and current status?
The ClinicalTrials.gov record indicates the project status is not yet recruiting. The sponsor is The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The time stamp for the record is February 11 2026. The study focuses on a portable detection system for diquat quantification in blood.
- 1. What is being studied? A portable mass spectrometry system paired with a diquat quantitative detection kit to measure diquat in human blood, in a not yet recruiting trial.
- 2. Where is the study conducted? The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School in China.
- 3. What must be shown before clinical use? The device must demonstrate adequate analytical performance and safety in accordance with medical device regulatory requirements during regulatory review.
- 4. How can I learn more? See the ClinicalTrials.gov page linked in this article for the study record and status.
In summary this regulatory aware review indicates the portable diquat detection system is in early stages. Stakeholders should monitor the ClinicalTrials.gov record and sponsor communications for updates on recruitment status and study results that may support future approvals.
Disclaimer: This article provides general information for professionals. It is not legal advice. For regulatory decisions consult official guidance and the sponsor’s submissions.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07399574?term=medical+device