Assessment of multiple drugs of abuse simultaneously using Toxplex Urine Array to confirm clinical performance
| ISRCTN | ISRCTN44551841 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44551841 |
| Integrated Research Application System (IRAS) | 356718 |
| Sponsor | Randox (United Kingdom) |
| Funder | Randox Laboratories Limited |
- Submission date
- 29/06/2026
- Registration date
- 08/07/2026
- Last edited
- 11/08/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Drug abuse in any form gives rise to serious negative consequences not only for the abuser, by devastating their mental and physical health, but also for the whole of society. It is an indirect and direct cause of many crimes and also in the spread of diseases. It is very costly, with costs related to crime, medical care, treatment and welfare programs for addicted individuals and wasted working hours. Urine drug testing can provide a tool for detecting users and for monitoring the compliance of subjects in recovery programs. Randox has developed a sensitive, multidrug approach for detecting 23 drugs as well as a marker for sample dilution in urine samples as an aid to diagnosis. The study aims to test the performance of the Randox Evidence MultiSTAT Toxplex Urine Array as a preliminary testing device for clinical use in the measurement of drugs of abuse.
Who can participate?
Persons aged 18 years and over who have consented for their leftover urine sample being used for Research and Development
What does the study involve?
The study will use de-identified leftover pooled residual samples received at Randox Clinical Laboratory Services (RCLS) during routine diagnostic testing. Results using the Evidence MultiSTAT Toxplex Urine Array will be compared to another preliminary testing device to demonstrate clinical performance. In addition, a number of known positives sourced from the US will be run blinded as part of the study to demonstrate performance for both positive and negative samples. Positive samples detected will be confirmed using chromatography methods.
What are the possible benefits and risks of participating?
Although no clinical decisions will be made on the results of this study, participants will be contributing to the wider scientific community by participating in the assessment of a multiplex test that can detect large numbers of drugs of abuse simultaneously, which aids in determining which drug or combination of drugs has been administered. This screening device aids in determining the best treatment pathway. As the study is being conducted with leftover de-identified clinical samples, there are no risks to the participants.
Where is the study run from?
Randox Clinical Laboratory Services (RCLS), Northern Ireland
When is the study starting, and how long is it expected to run for?
July 2026 to August 2026
Who is Funding the Study?
Randox Laboratories Ltd, Northern Ireland
Who is the main contact?
Damien McAleer, damien.mcaleer@randox.com
Contact information
Principal investigator
Randox Science Park
30 Randalstown Road
Antrim
BT41 4LP
United Kingdom
| Phone | +44 (0)2894422413 |
|---|---|
| kristopher.pentland@randox.com |
Public, Scientific
Randox Laboratories limited
55 Diamond Road
Crumlin
BT29 4QY
United Kingdom
| Phone | +44 (0)2894422413 |
|---|---|
| victoria.anderson@randox.com |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Single-center observational study |
| Scientific title | Evidence MultiSTAT DOA Toxplex Urine Array clinical performance study |
| Study acronym | ToxPlex Urn CPS |
| Study objectives | The clinical performance study is intended to demonstrate the clinical performance of the Evidence MultiSTAT Drugs of Abuse (DOA) Toxplex Urine Array in a clinical laboratory setting with trained laboratory personnel. The Evidence MultiSTAT DOA ToxPlex Urine Array are in vitro diagnostic tests for the semi-quantitative determination of the parent molecule and metabolites of drugs in human urine. The Evidence MultiSTAT Drugs of Abuse (DOA) Toxplex Urine Array in a clinical laboratory setting with trained laboratory personnel. The Evidence MultiSTAT DOA ToxPlex Urine Array detects the following drugs at the specified cut-off: 1. Methamphetamine (500 ng/ml) 2. Methylenedioxy-methamphetamine (MDMA) (500 ng/ml) 3. Amphetamine (500 ng/ml) 4. Tricyclic antidepressants (500 ng/ml) 5. Noroxycodone (100 ng/ml) 6. Opiate (300 ng/ml) 7. 6-Acetylmorphine (6-MAM) (10 ng/ml) 8. Benzodiazepines 1 (200 ng/ml) 9. Benzodiazepines 2 (200 ng/ml) 10. Barbiturates (200 ng/ml) 11. Cannabinoids (50 ng/ml) 12. Methadone (300 ng/ml) 13. Benzoylecgonine/cocaine (150 ng/ml) 14. Tramadol (200 ng/ml) 15. Fentanyl (2 ng/ml) 16. Buprenorphine (5 ng/ml) 17. Phencyclidine (PCP) (25 ng/ml) 18. Zolpidem (20 ng/ml) 19. Ketamine (300 ng/ml) 20. Pregabalin (1000 ng/ml) 21. Adulterant Check (20 mg/dl) 22. Ethyl glucuronide (ETG) (1000 ng/ml) 23. Acetaminophen (50 µg/ml) 24. Salicylates (50 µg/ml) The test system will provide a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. |
| Ethics approval(s) |
Approved 08/07/2026, London - Dulwich Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JO, United Kingdom; +44 (0)207 104 8290; dulwich.rec@hra.nhs.uk), ref: 26/LO/0540 |
| Health condition(s) or problem(s) studied | Drugs of abuse use |
| Methodology | An observational study will take place where 100 left-over consented pooled samples (suspected negatives) will be assessed on the Evidence MultiSTAT Toxplex Urine Array EV4505 to test for the presence of parent molecules and metabolites of drugs in the human urine sample. Negative samples will be assessed on another preliminary testing device, Evidence Investigator Drugs of Abuse Array EV3512. An additional 30 blinded positives will also be assessed for the study, which have been sourced from the US with an IRB-approved waiver of consent in place. Positive samples will be confirmed by confirmatory methods such as gas chromatography-mass spectrometry (GC/MS) and liquid chromatography-tandem mass spectrometry (LC/MS/MS). Study endpoints will include the correlation of results with another preliminary testing method (Randox Evidence Investigator Drugs of Abuse Array EV3512) for negative samples and against confirmatory methods such as GC/MS or LC/MS/MS for positive samples with results reviewed to determine the percentage agreement, diagnostic sensitivity, diagnostic specificity, positive predictive value, negative predictive value and likelihood ratio. |
| Intervention type | Other |
| Primary outcome measure(s) |
True Positive (TP) = Number of samples positive by test method and reference method |
| Key secondary outcome measure(s) |
There are no secondary outcomes |
| Completion date | 31/08/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 110 Years |
| Sex | All |
| Target sample size at registration | 130 |
| Total final enrolment | 130 |
| Key inclusion criteria | 1. Person aged ≥18 years 2. Person consented for leftover urine sample being used for Research and Development |
| Key exclusion criteria | 1. Person aged <18 years 2. Person who have not consented for left over urine sample being used for Research and Development |
| Date of first enrolment | 01/07/2026 |
| Date of final enrolment | 31/07/2026 |
Locations
Countries of recruitment
- United Kingdom
- Northern Ireland
- Ireland
Study participating centre
30 Randalstown Road
Antrim
BT41 4LP
Northern Ireland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
11/08/2026: Ethics approval date added.
30/06/2026: Study's existence confirmed by the HRA.
