A Novel, Rapid, and Simplified Approach for Streptococcus pneumoniae Detection: Project for the Design of a Molecular Imprinting-Based Rapid Test Kit for High-Sensitivity Determination of Pneumolysin in Urine

Streptococcus pneumoniae belongs to the class of bacteria that produce toxins capable of forming pores in host cells. As it secretes pneumolysin to create these pores, the pneumolysin protein is present in the patient's urine during every stage of the disease. In global literature, although antigen-based test kits designed to analyse pneumolysin in urine have been developed, they have not been effectively utilized due to low sensitivity caused by cross-reactions and the complex, variable pH structure of urine. Consequently, there is currently no test kit in the global market capable of effectively diagnosing pneumococcal diseases. The primary reason for this is that existing kits rely on antibody-antigen interactions. This specific interaction is highly susceptible to environmental conditions; since body fluids are complex and possess fluctuating pH levels, these test kits fail to operate effectively. Furthermore, since antibodies are expensive, have a short shelf life, and require stringent storage conditions, there is a critical need for an alternative with high sensitivity, chemical and mechanical durability, and low cost. At this juncture, Molecularly Imprinted Polymers (MIPs)—which can mimic antibody-antigen interactions, possess higher mechanical and chemical resistance than their natural counterparts, and function independently of environmental conditions—emerge as a more cost-effective option. The utilization of MIPs will pave the way for technologies that simplify the diagnosis of many similar diseases.

Guided by the 'from idea to product' principle, this project aims to design a molecular imprinting-based rapid test kit for the analysis of pneumolysin in urine—a first in global literature—to enable point-of-care detection of Streptococcus pneumoniae. Through this pioneering study, it will be possible to detect S. pneumoniae in a low-cost, simple, and effective manner using molecular imprinting technology for the first time globally. Consequently, instead of high-cost, imported products currently used for the diagnosis of this disease, a more cost-effective product developed entirely through indigenous and national resources will be utilized. This initiative will serve to alleviate both the clinical and financial burden on our national healthcare system and hospitals. Furthermore, with early and easy diagnosis, treatment can be initiated at the onset of the disease. This is expected to increase the rate of cases resolved through short-term or outpatient treatment, thereby reducing the workload of hospitals and significantly improving patients' quality of life.

The project is being conducted by the R&D specialists and research personnel of Türkiye Vaccine Institute.