Gazelle COVID-19 Test Clinical Accuracy Protocol

Study Overview
=================
Brief Summary
-----------------
Gazelle COVID-19 is a fluorescent lateral flow immunoassay and accompanying Reader intended for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset. The study will be conducted To obtain data to measure the positive percent agreement and negative percent agreement of the Gazelle COVID-19 Test compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).The study will assess Gazelle COVID-19 Test performance using dual mid-turbinate nasal swab samples. This study will primarily assess Gazelle COVID-19 Test performance on symptomatic subjects (within five days of onset of symptoms) at point of care (POC). A subset of asymptomatic subjects will be enrolled after the symptomatic subject enrollment is complete.

Official Title
-----------------
Gazelle COVID-19 Test Clinical Accuracy Protocol

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: Applied Biosystems TaqPath COVID- 19 Combo Kit


Participation Criteria
=================
Eligibility Criteria
-----------------
Symptomatic study: Inclusion Criteria: The presence of clinical signs and symptoms consistent with COVID-19. Signs and symptoms include: Fever Coughing Shortness of breath Recent loss of sense of smell or taste Chills Repeated shaking with chills Muscle pain Headache Sore throat Vomiting or diarrhea Within 1-5 days of symptom onset Informed consent for all the samples will be obtained from the subject or obtained from the parent/guardian in case the patient is a minor All ages All genders Pregnant women Exclusion Criteria: Severe disease requiring immediate medical intervention Inability to tolerate sampling procedure (nasal swab) Failure to provide informed consent Nasal deformities preventing sampling by swab Ongoing nosebleeds or use of a nasal spray within the last 4 hours. Asymptomatic patients Asymptomatic study: Inclusion criteria: Present to the facility for a COVID-19 test without symptoms Informed consent for all specimens will be obtained from the patient or obtained from the parent/guardian in case the patient is a minor Exclusion Criteria: Exclusion criteria include one or more of the following: Severe disease requiring immediate medical intervention Inability to tolerate sampling procedure Is below 2 years old Failure to provide informed consent Nasal deformities preventing sampling by swab Ongoing nosebleeds or use of a nasal spray within the last 4 hours. Presence of typical symptoms of COVID-19 (fever, sore throat, fatigue, etc.)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Applied Biosystems TaqPath COVID- 19 Combo Kit|Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive percent agreement and negative percent agreement of the Gazelle COVID-19 Test compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) will be measured |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity on at least 30, maximum 65, SARS-CoV-2 positive patient samples will be assessed |  | 6 months |