Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal Pharyngitis
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The objective of this pilot study is to acquire images using the Strepic® device, a clinical prototype that has been designed specifically as a viable, low-cost, commercially realizable autofluorescence-based diagnostic test, using (1) fluorescence and (2) white light image data, as well as other clinical data points. By acquiring and analyzing the images of pharyngeal bacterial fluorescence and white light patterns in patients with Group A Streptococcus (GAS)-associated pharyngitis and comparing them with those observed in non-GAS pharyngitis, it is believed an algorithm can be developed such that the device will improve the ability of clinicians to quickly and accurately identify GAS infections.
The Strepic® device is a qualitative point-of-care diagnostic test for the detection of GAS pharyngitis. The test uses direct visualization of the pharynx with a light source of specified wavelengths, causing excitation of endogenous fluorophores that emit a characteristic colored light pattern. White light images may give additional diagnostic accuracy through use of an artificial intelligence analysis of a large set of images of GAS and non-GAS pharyngitis.
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Layout table for eligibility information
Ages Eligible for Study:
7 Years to 64 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients presenting to participating U.S. emergency departments or clinics with complaint of pharyngitis will be screened.
All patients aged 7-64 years of age with suspected GAS pharyngitis with modified Centor (McIsaac) score ≥2; and
Patient agrees to participate in study and patient or parent/guardian sign consent/assent form.
Pharyngeal swab performed immediately prior to study team approach;
Prior enrollment in this study;
Pharyngeal symptoms >7 days;
Antibiotic use within one week of index visit;
Inability to open mouth to visualize the pharynx; and
Inability to understand English or Spanish, as study forms including consent and assent forms will be written in English and Spanish;
Woman who is pregnant (self-reported, pregnancy test will not be performed) or nursing;
Current prisoner (define as an individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution).