Target Product Profile: Trachoma Surveillance Diagnostic - Antigen Lateral Flow Test

Trachoma is the leading cause of infectious blindness in the world. The infectious agent of trachoma is the bacteria Chlamydia trachomatis that spreads by contact with an infected person’s hands or clothing. Infection leads to conjunctival inflammation that produces trachoma follicles visible on physical exam. Yet it is the repeated episodes of reinfection and inflammation that lead to scarring, distortion of the eyelid, and in-turning of the lid with the eyelashes touching the cornea, called trichiasis, that leads to blindness. Infectious spread is prevented by good hygiene practices, including hand and face cleanliness, and environmental improvements. Antibiotics, namely oral azithromycin or topical tetracycline, are an effective treatment of active trachoma infections, while surgery is indicated to manage trichiasis.

The Alliance for Global Elimination of Blinding Trachoma by 2020 (GET 2020), led by the World Health Organization (WHO), developed the SAFE strategy to reach their goal of eliminating trachoma by 2020 through Surgery, Antibiotics, Facial cleanliness, and Environmental improvement. The most commonly used antibiotic for trachoma, oral azithromycin, is donated free of charge by the pharmaceutical company Pfizer and is given to entire communities. In order to assess the impact of the community-wide antibiotic distribution, commonly known as mass drug administration (MDA), trachoma surveillance is performed with a physical exam of the eye. This method of diagnosis is acceptable for early control programs; however, as we move closer to elimination of trachoma, more sensitive and specific diagnostics are needed.

This report proposes a target product profile (TPP) for the development of a new diagnostic technology that facilitates an accurate stopping decision phase for MDA. Each attribute has an “acceptable” standard that must be met and an “ideal” standard that, if met, would maximize the target product’s value. This TPP focuses on the development of a lateral flow rapid diagnostic test (RDT) that detects trachoma antigens.

As reference, for a description of the currently available nucleic acid amplification tests for trachoma, please see Appendices A-1 and A-2.

Publication date: January 2015

Target Product Profile: Trachoma surveillance diagnostic - antigen lateral flow test

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