Covid19
Conditions
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.
Interventions
DIAGNOSTIC_TESTApplied Biosystems TaqPath COVID- 19 Combo Kit
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Sponsors
Hemex Health
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Sensitivity and specificity on at least 30, maximum 65, SARS-CoV-2 positive patient samples will be assessed | 6 months |
Countries
United States
Contacts
Primary ContactPRIYA THOTA, MD
Backup ContactDavid Bell, MD
Outcome results
None listed