Gazelle COVID-19 Test Clinical Accuracy Protocol
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The presence of clinical signs and symptoms consistent with COVID-
- •Signs and symptoms include:
- •Shortness of breath
- •Recent loss of sense of smell or taste
- •Repeated shaking with chills
- •Muscle pain
- •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 genders
- •Pregnant women
排除标准
- •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.)
结局指标
主要结局
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
时间窗: 3 months
次要结局
- Sensitivity and specificity on at least 30, maximum 65, SARS-CoV-2 positive patient samples will be assessed(6 months)