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Development of POC Assays to Quantify anti-Tuberculosis Antibiotics in Blood



Development of POC Assays to Quantify anti-Tuberculosis Antibiotics in Blood

Fast-Track proposals will be accepted Number of anticipated awards: 1-2 Budget (total costs, per award): Phase I: up to $300,000/year for up to 1 year; Phase II: up to $1,500,000/year for up to 3 years



Tuberculosis (TB) is currently the leading infectious cause of death worldwide. TB treatment includes multiple different combinations of antibiotics, doses, and long time periods depending on whether TB is classified as drug-sensitive or drug-resistant. Moreover, therapy is often modified due to factors such as identification of antibiotic resistance, drug-induced toxicity, treatment failure, antibiotic availability, etc. Rapid determination of blood antibiotic concentrations in the clinical laboratory using technologies that do not require sophisticated equipment would allow clinicians to monitor antibiotic concentrations during treatment and allow for dose adjustments to increase efficacy. This would prevent or reduce the development of resistance, treatment failure, and antibiotic induced toxicity and could improve patient survival. Currently, TB antibiotic concentrations are measured only in highly specialized laboratories using expensive instruments, making regular monitoring of antibiotic blood concentrations essentially impractical in the global clinical field.

Project goal:

The goal of this project is to develop a rapid POC test to quantify TB antibiotic blood concentrations. Desired outcomes include a portable device (e.g. sensors, readers, etc.) requiring a small blood sample (e.g. strips, capillary tubes, etc.) that will provide consistent rapid readouts during the patient’s visit (less than 1 hour).

Phase I activities may include:

Development of a prototype POC test to quantify TB antibiotic concentrations.

• Optimization of the POC test to quantify concentrations for multiple antibiotics in one sample simultaneously.

• Evaluation of the POC test to reliably quantify antibiotic concentrations directly from total blood and/or plasma.


Phase II activities may include:

Determination of validity, sensitivity, and specificity of the POC test.

• Optimization of POC test characteristics, such as portability and development of operator manual.

• Evaluation and determination of the stability of the POC test kit (e.g. shelf life, storage conditions, etc.)

• Scale-up manufacturing of POC test kits.

This SBIR will not support:

The design and conduct of clinical trials (see Appendix H.1 for the NIH definition of a clinical trial).

For clinical trial support, please refer to the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement program announcement or the NIAID Investigator-Initiated Clinical Trial Resources webpage.

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