Clinical Evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device and the BinaxNOW™ COVID-19 Antibody Self Test Clinical Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 263
- 试验地点
- 9
- 主要终点
- Clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test
研究概览
简要总结
Performance evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device (Professional Use) and with BinaxNOW™ COVID-19 Antibody Self Test wehn used with fingerstick capillary whole blood and plasma samples. The BinaxNOW™ Antibody Tests are lateral flow tests that measure SARS-CoV-2 IgG antibodies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Operator of the device will be blinded to the outcome
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is 18 years of age or older.
- •Evaluable individuals with a prior confirmed SARS-CoV-2 infection with prior COVID-19 symptoms with symptoms onset > 14 days prior to the study, or symptoms onset 8-14 days prior to the study, or symptoms onset 0-7 days prior to study.OR
- •Evaluable individuals confirmed negative by SARS-CoV-2 RT-PCR using a sample obtained within 7 days prior to or on the day of the study.
- •Participant agrees to complete all aspects of the study.
排除标准
- •Participant has already participated in this study on a previous occasion.
- •Participant is enrolled in a study to evaluate a new drug.
- •Participant has a visual impairment that cannot be restored using glasses or contact lenses.
- •Participant is unable or unwilling to provide informed consent.
- •Participant is a vulnerable person as deemed unfit for the study by the Principal Investigator.
- •Participant has a condition deemed unfit to safely perform the test by the investigator.
- •Participant is a practising health-care professional or laboratory scientist / technician.
结局指标
主要结局
Clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test
时间窗: Through study completion, an average of 6 months
to evaluate the clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test Device when used by a professional user.
Clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test
时间窗: Through study completion, an average of 6 months
to evaluate the clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test when used by a lay person.
次要结局
- Diagnostic sensitivity and specificity(Through study completion, an average of 6 months)
- Self Test user usability(Through study completion, an average of 6 months)
- Professional user usability(Through study completion, an average of 6 months)
- Matrix Equivalence Professional Use(Through study completion, an average of 6 months)