Gazelle COVID-19 Test Clinical Accuracy Protocol
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,500
- Locations
- 1
- Primary Endpoint
- 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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The presence of clinical signs and symptoms consistent with COVID-
- •Signs and symptoms include:
- •Shortness of breath
- •Recent loss of sense of smell or taste
- •Repeated shaking with chills
- •Muscle pain
- •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 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.)
Outcomes
Primary Outcomes
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
Time Frame: 3 months
Secondary Outcomes
- Sensitivity and specificity on at least 30, maximum 65, SARS-CoV-2 positive patient samples will be assessed(6 months)