Clinical Performance of the Checkable Medical At-Home Strep A Test

Study Overview
=================
Brief Summary
-----------------
The Checkable Medical At-Home Strep A Test is a rapid chromatographic immunoassay for the qualitative detection of Group A Strep (GAS) antigens from throat swabs. The purpose of the study is to evaluate the clinical performance of the investigational device (i.e., sensitivity, specificity, NPV and PPV) when used by untrained lay persons to detect the presence of Group A Streptococcal antigens in throat swab specimens from individuals five years of age and older with signs and symptoms of pharyngitis, such as fever and sore throat.

Detailed Description
-----------------
The study is a prospective, consecutive, non-interventional multicenter study to evaluate the clinical performance of the Checkable Medical At-Home Strep A Test when the test is performed by non-trained adult lay users. Patients or parents/legal guardians of patients presenting with signs and symptoms of pharyngeal GAS infections will be recruited at primary care or urgent care clinics. Informed consent will be obtained from adult subjects and from the parents/guardians of pediatric subjects. Pediatric subjects 7 years of age or greater will be asked for their assent. The lay user will be provided with a Checkable Medical At-Home Strep A Test kit. The user and patient will be provided with a quiet, private space where the user can collect the throat swab specimen and perform the investigational test. Once the lay user has collected the swab sample for the Checkable Medical At-Home Strep A Test and performed the test, she/he will document the test result. The Checkable Medical At-Home Strep A Test result is not to be shared with members of the site team who are providing healthcare to the subject. When all sample collection, testing and interpretation activities related to the investigational test are completed, a healthcare provider at the study site will collect two additional swab samples. One of these samples will be sent to a central lab where it will be cultured for GAS. An additional sample will be tested using the organization's standard of care (SOC) rapid Strep A test. Subjects will be diagnosed and treated in accordance with routine SOC which may include an FDA-cleared rapid GAS test. The Checkable Medical At-Home Strep A Test will not be used to diagnose or treat study subjects. This study will take place in at least six sites in at least three different regions of the United States. The results from the Checkable Medical At-Home Strep A Test will be used to compare with the diagnostic truth obtained through culture to compute diagnostic accuracy parameters including sensitivity, NPV, specificity and PPV.

Official Title
-----------------
Clinical Performance of the Checkable Medical At-Home Strep A Test

Conditions
-----------------
Streptococcus Pyogenes Infection, Pharyngitis, Respiratory Tract Infections

Intervention / Treatment
-----------------
* Diagnostic Test: untrained lay user performs investigational diagnostic test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects seeking medical care for two or more of the following signs/symptoms of pharyngeal streptococcal infections: pharyngeal pain [with or without swallowing], tonsillar swelling with exudates, pharyngeal erythema, tender cervical lymphadenopathy, fever. Subjects who have not received antibiotic treatment within the past 14 days. Subjects (or their parents/guardians) provide written informed consent/assent to participate in the study Exclusion Criteria: 1. Lay users who are accompanying patients are unwilling/unable to collect throat swab sample from a child or adult.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symptomatic Adult and Pediatric Subjects<br>Untrained lay user to collect throat swab specimen and perform investigational test. | Diagnostic Test: untrained lay user performs investigational diagnostic test<br>* Untrained lay users (parents/guardians of pediatric subjects or friends/family members of adult subjects) collect throat swab specimens and perform the investigational diagnostic test.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Sensitivity and Clinical Specificity | Sensitivity is the proportion of subjects with a positive bacterial culture that are also positive in the investigational Strep A test (+). Specificity is the proportion of subjects with a negative bacterial culture that are also negative in the investigational Strep A test (-). | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative Predictive Value | Negative Predictive Value (NPV) is the proportion of subjects with negative investigational Strep A test results who also have negative cultures (diagnostic truth); calculated as 100 x d/(c+d). | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
In vitro diagnostic