Isoniazid Urine Test Strip for TB Medication Adherence Support

A simple urine strip designed to support isoniazid adherence monitoring

Isoniazid remains one of the most widely used medicines in tuberculosis prevention and treatment programs. In real-world TB care, one of the biggest challenges is not only selecting the right regimen, but also confirming whether medication has actually been taken.

The Isoniazid Urine Test Strip is designed as a simple, rapid urine-based screening tool to support medication adherence monitoring. It provides a visual result that can help healthcare workers, TB programs, clinics and public health teams identify whether isoniazid intake is likely to have occurred within the expected detection window.

This product is listed with the U.S. FDA under product code MIG, described in FDA’s product classification database as “strip, test isoniazid.” The FDA product code system is used to classify and track medical devices across FDA regulatory databases.([FDA Access Data][1])

 Intended use

The Isoniazid Urine Test Strip is intended for qualitative detection of isoniazid-related urinary markers as an aid in medication adherence monitoring.

It is not intended to diagnose tuberculosis, determine drug resistance, replace clinical judgment, or guide treatment changes without professional review.

 Why adherence monitoring matters

TB preventive therapy and TB treatment regimens can be highly effective when taken correctly. However, missed doses, incomplete courses and unrecognized non-adherence remain important barriers in community-based TB programs.

Traditional directly observed therapy is resource-intensive. A simple urine-based adherence check may help programs identify patients who need additional counseling, support or follow-up.

Key features

* Simple urine-based strip format
* Rapid visual interpretation
* Designed for isoniazid adherence support
* Suitable for TB programs, clinics and outreach settings
* No complex instrument required
* Can support patient counseling and follow-up workflows
* FDA listed under product code MIG

Typical applications

* Latent TB infection treatment adherence support
* TB preventive therapy program follow-up
* Community TB outreach programs
* Public health adherence monitoring
* Clinical workflow support for isoniazid-containing regimens
* Research and implementation programs focused on TB medication adherence

 Important limitation

A positive or negative result should be interpreted together with medication history, timing of last dose, urine sample quality and clinical context. The test is not a substitute for clinical evaluation, microbiological TB testing, drug susceptibility testing or treatment decision-making.

 Product summary

The Isoniazid Urine Test Strip provides TB programs with a practical tool to support medication adherence conversations. It is designed to be simple, fast and easy to integrate into real-world care workflows where medication intake confirmation may help improve follow-up and patient support.