Neisseria gonorrhoeae and Chlamydia trachomatis cause urethritis in males and mucopurulent cervicitis in females. A device distinguishing these pathogens concurrently in a single test would greatly enhance diagnosis of this disease syndrome. Oligodeoxynucleotide probes specific for each organism have been synthesized and found to function in a solid-phase sandwich assay with colorimetric detection. However, the sensitivity is not at a clinically relevant level. The primary focus of this Phase I is to demonstrate the feasibility of using chemiluminescence detection in the dipstick format to increase the assay sensitivity. In addition, probes will be included that will detect the presence of beta-lactamase producing Neisseria gonorrhoeae. These probes will be specific for the mRNA coding for the beta-lactamase enzyme. mRNA like rRNA typically present in the cell at higher copy number than the corresponding gene or plasmid. The assay win be optimized for high sensitivity using cultured microorganisms. This work will enable the development during Phase II of an automated multi-target test that can be performed in 30 minutes in the physicians office or clinical laboratory.
