Assessment of multiple drugs of abuse simultaneously using Toxplex Urine Array to confirm clinical performance

Evidence MultiSTAT DOA Toxplex Urine Array clinical performance study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN44551841

Enrollment

130

Registered

2026-07-08

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drugs of abuse use Other

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to 110 Years

Inclusion criteria

Inclusion criteria: 1. Person aged =18 years 2. Person consented for leftover urine sample being used for Research and Development

Exclusion criteria

Exclusion criteria: 1. Person aged <18 years 2. Person who have not consented for left over urine sample being used for Research and Development

Design outcomes

Primary

Measure	Time frame
Diagnostic sensitivity of the Evidence MultiSTAT Toxplex Urine Array compared with the reference method measured using 100 x [True Positive/(True Positive + False Negative)] at a single timepoint;Diagnostic specificity of the Evidence MultiSTAT Toxplex Urine Array compared with the reference method measured using 100 x [True Negative/(False Positive +True Negative)] at a single timepoint;Overall percentage agreement measured using [(True Positive+True Negative)/Total number of Samples] x 100 at a single timepoint;True Positive (TP) = Number of samples positive by test method and reference method True Negative (TN) = Number of samples negative by test method and reference method False Positive (FP) = Number of samples positive by test method but negative by reference method False Negative (FN) = Number of samples negative by test method but positive by reference method	—

Measure

Time frame

Diagnostic sensitivity of the Evidence MultiSTAT Toxplex Urine Array compared with the reference method measured using 100 x [True Positive/(True Positive + False Negative)] at a single timepoint;Diagnostic specificity of the Evidence MultiSTAT Toxplex Urine Array compared with the reference method measured using 100 x [True Negative/(False Positive +True Negative)] at a single timepoint;Overall percentage agreement measured using [(True Positive+True Negative)/Total number of Samples] x 100 at a single timepoint;True Positive (TP) = Number of samples positive by test method and reference method True Negative (TN) = Number of samples negative by test method and reference method False Positive (FP) = Number of samples positive by test method but negative by reference method False Negative (FN) = Number of samples negative by test method but positive by reference method

—

Secondary

Measure	Time frame
There are no secondary outcomes	—

Countries

Ireland, Northern Ireland, United Kingdom

Contacts

Public ContactVictoria Anderson

victoria.anderson@randox.com+44 (0)2894422413

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Sep 19, 2026