Gazelle COVID-19 is a fluorescent lateral flow immunoassay and accompanying Readerintended for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasalswab specimens from individuals who are suspected of COVID-19 by their healthcareprovider within 5 days of symptom onset. The study will be conducted To obtain data tomeasure the positive percent agreement and negative percent agreement of the GazelleCOVID-19 Test compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).Thestudy will assess Gazelle COVID-19 Test performance using dual mid-turbinate nasal swabsamples. This study will primarily assess Gazelle COVID-19 Test performance onsymptomatic subjects (within five days of onset of symptoms) at point of care (POC). Asubset of asymptomatic subjects will be enrolled after the symptomatic subject enrollmentis complete.
Diagnostic Test: Applied Biosystems TaqPath COVID- 19 Combo Kit
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
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.)
Northwest Pathology drive thru site, Bellingham International Airport
Bellingham, Washington, United States
Investigator: Bri Spencer
Bri.Spencer@nwlaboratory.com
PRIYA THOTA, MD
2162339405
p.thota@hemexhealth.com
David Bell, MD
d.bell@hemexhealth.com
Ryan Robert Fortna, MD, PhD, Principal Investigator
Northwest Pathology