Gazelle COVID-19 Test Clinical Accuracy Protocol

Hemex Health

Status: Enrolling

Conditions: Covid19

Treatments: Diagnostic Test: Applied Biosystems TaqPath COVID- 19 Combo Kit

Study type: Observational

Funder types: Industry

Identifiers

NCT04987918

GZL-FC10-PTL-0001

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.)