Assay Modifications to a Streptococcal Pharyngitis Rapid Lateral Flow Test for Mobile Health Applications (LB854)

Streptococcal tonsillitis, streptococcal pharyngitis,or streptococcal sore throat (known commonly as strep throat) is a type of pharyngitis caused by a group A streptococcal infection. It affects the pharynx including the tonsils and possibly the larynx. Common symptoms include fever, sore throat, and enlarged lymph nodes. It is the cause of 37% of sore throats among children and 5‐15% in adults. Strep throat is contagious, typically spread via close contact with an infected individual. A preliminary diagnosis is made based on the results of a rapid lateral flow test. A follow up definitive diagnosis is made based on the results of a throat culture. However, these tests are not always needed as diagnosis for administration of treatment may also be made by a physician based on the symptoms. We have previously developed a wireless mobile health application for diagnosis of streptococcal pharyngitis using a smart phone enabled avatar system which uses medical algorithms for diagnosis of this disease, taking advantage of the standard questions and answers typically used by physicians in practice. To further provide confirmation testing of this analysis system, we here describe customization, refinements, and modifications to assay procedures and chemical components of an FDA approved lateral flow rapid diagnostic test for Streptococcal Pharyngitis with a focus on mobile health applications. Specifics of our findings can be applied to other lateral flow assays currently in use for confirmatory tests of other diseases.