Trachoma is a blinding disease caused by Chlamydia trachomatis (CT). Mass drug treatment with azithromycin (MDA) is part of the WHO-endorsed 'SAFE' strategy for trachoma control in endemic communities. However, to accurately assess the feasibility of eliminating trachoma, it is essential to have a diagnostic test that can correcty measure the true status of ocular CT infection in individuals. In designing the optimal regimen for antibiotic treatment, it is important to know if re-emergent infection represents treatment failure, reinfection from untreated members of the community, or reinfection from sources outside the community. The most widely used test for monitoring trachoma is conjunctival examination using the WHO simplified grading system. It has been shown that the positive predictive values for these tests are far lower than those of the NAAT based assays. This indicates that basing treatment decisions solely on the simplified grading system will result in treatment of a considerable number of uninfected persons. The commercial NAAT assays presently available are too expensive, too complex, or too unreliable for use in national programs. There is an urgent need for a rapid, cost effective, reliable NAAT test for C. trachomatis to assist in measuring progress towards the elimination of trachoma. We propose to develop rapid, accurate, sensitive and cost effective NAAT based POC system to fulfill the unmet market needs in resource limited settings (RLS). The system can be readily expanded to include other tests for use in RLS including HIV-Viral load, Syphilis, MGen, HPV and HCV.
Public Health Relevance Statement: Public Health Relevance: Trachoma is a blinding disease caused by ocular infection with CT. Trachoma continues to be the target of a global effort by the WHO to eliminate the disease as a public health concern by the year 2020. Our proposed product will result in a field-deployable device for diagnosis ocular CT and the system can be readily expanded to include other assays.
Project Terms: Antibiotic Therapy; Archives; assay development; Azithromycin; base; Biological Assay; Caliber; Chlamydia; Chlamydia trachomatis; Clinical; Communities; Complex; cost effective; Custom; Cyclopentane; design; Detection; Devices; Diagnosis; Diagnostic; Diagnostic tests; Disease; Evaluation; experience; Eye; Eye Infections; Foundations; Hepatitis C virus; HIV; Human Papillomavirus; Individual; Infection; innovation; Laboratories; Laboratory Research; Laboratory Scientists; Licensing; Marketing; Measures; member; Methods; Monitor; nanoscale; National Institute of Diabetes and Digestive and Kidney Diseases; Nucleic Acid Amplification Tests; nucleic acid detection; Nucleic Acid Probes; Oligonucleotides; Ophthalmology; Organic Chemistry; Organism; Patients; Peptide Nucleic Acids; Persons; Pharmacotherapy; Predictive Value of Tests; professor; programs; public health medicine (field); public health relevance; Regimen; Research; Research Personnel; Resources; Ribosomal RNA; Sampling; Simplexvirus; Source; Specificity; Swab; Syphilis; System; Testing; TimeLine; Trachoma; Treatment Failure; Validation; Viral Load result; Visual
