Recruiting

Gazelle COVID-19 Test

Sponsor:

Hemex Health

Code:

NCT04987918

Conditions

Covid19

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Applied Biosystems TaqPath COVID- 19 Combo Kit

Study Details

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.

Conditions

Covid19

Study ID

NCT04987918

Start date

Aug 20, 2021

Status verified date

Aug, 2022

Completion date

Dec 30, 2022

Anticipated

Primary completion date

Dec 15, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Interventions

Applied Biosystems TaqPath COVID- 19 Combo Kit

Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

PRIYA THOTA, MD

2162339405p.thota@hemexhealth.com

David Bell, MD

d.bell@hemexhealth.com

Locations

Northwest Pathology drive thru site, Bellingham International Airport

Recruiting

Bellingham, Washington, United States, 98226

Contacts

Bri Spencer

Bri.Spencer@nwlaboratory.com

More Information

Sponsor

Hemex Health

Last update posted

Aug 10, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hemex Health on 2022-08-10.