Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis

Study Overview
=================
Brief Summary
-----------------
Participants who meet the eligibility criteria and who consent to participation or whose parents/legal guardian consent to their participation, will be enrolled in the study for a period of up to 14 days. Enrolment visit (Day 1) assessments for all participants will include the collection of throat swabs, testing by staff at the site using the ellume·lab Group A Strep Test and testing for Group A Streptococcus by a central laboratory using bacterial culture and polymerase chain reaction (PCR). All participants will be followed up with a phone assessment of adverse events between Days 2-14.

Official Title
-----------------
A Prospective Multi-Centre Study of the Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis

Conditions
-----------------
Group A Streptococcal Infection

Intervention / Treatment
-----------------
* Diagnostic Test: ellume·lab Group A Streptococcus Test
* Diagnostic Test: Bacterial Culture
* Diagnostic Test: Polymerase Chain Reaction (PCR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female participants aged 3 years of age or older Must currently be presenting with symptoms characteristic of pharyngitis, possibly Group A Strep, including: Acute onset of sore throat; Fever ≥ 37.8° C (100° F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° C or feeling feverish within 24 hours of presentation and; At least one of the following: Red and swollen/inflamed tonsils (or fossae); Pharyngeal or tonsillar exudate; o Cervical lymphadenopathy ≤ 14 days from onset of signs and symptoms of pharyngitis Parent/legal guardian of Participants < 18 years of age capable and willing to give informed consent Participants ≥18 years of age capable and willing to give informed consent Exclusion Criteria: Participants < 3 years of age Participants undergoing treatment with antibiotics, or those who have undergone treatment with antibiotics for current episode of pharyngitis Currently enrolled in another clinical trial or used any investigational device within 30 days preceding informed consent Participants 18 years of age or older unable to understand English and consent to participation Parent/legal guardian of Participants < 18 years of age unable to understand English and consent to participation of child Prior enrollment in this clinical validation study

Ages Eligible for Study
-----------------
Minimum Age: 3 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ellume·lab Group A Streptococcus Test<br>ellume·lab Group A Streptococcus Test Pharyngeal samples from participants will be tested with: ellume.lab Group A Streptococcus Test; Polymerase Chain Reaction (PCR) and bacterial culture. | Diagnostic Test: ellume·lab Group A Streptococcus Test<br>* ellume.lab Group A Streptococcus Test is a rapid diagnostic test intended to be used as an aid in the diagnosis of Group A Streptococcus in symptomatic participants. The sample type used is a throat swab.<br>Diagnostic Test: Bacterial Culture<br>* Pharyngeal swab is collected from participant and this specimen is inoculated into 5% sheep blood agar plates. Beta-haemolytic colonies are isolated, followed by latex agglutination test.<br>Diagnostic Test: Polymerase Chain Reaction (PCR)<br>* Polymerase Chain Reaction (PCR) is a molecular diagnostic technique for the detection and identification of Group A Streptococcus, both for clinical samples and isolates. Polymerase Chain Reaction (PCR) allows template bacterial RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to bacterial culture | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals | 1 Week | 
| The specificity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to bacterial culture | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals | 1 Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to PCR | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals | 1 Week | 
| The specificity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to PCR | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals | 1 Week | 
| Ease of use as assessed by operator questionnaire | The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale). | 1 Week |