Gazelle COVID-19 Test Clinical Accuracy Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-20

Study Completion Date

2022-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Covid19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Applied Biosystems TaqPath COVID- 19 Combo Kit

Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

* 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

* 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:

* 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.)

Eligible Sex

ALL

Accepts Healthy Volunteers

No