Gazelle COVID-19 Test Clinical Accuracy Protocol

Hemex Health1,500 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Covid19

Interventions

Applied Biosystems TaqPath COVID- 19 Combo KitDIAGNOSTIC_TEST

Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Medical Language ↔ Plain English

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.)

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

Time frame: 6 months

Central Contacts

PRIYA THOTA, MD

CONTACT

2162339405 p.thota@hemexhealth.com

David Bell, MD