Specimen Collection Study Protocol; Internal Biomerica Normal Specimen Collection and Banking for Use in COVID-19 Serological Product Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biomerica
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Matrix Equivalency
研究概览
简要总结
The specimens collected will be used to evaluate matrix equivalency in an immunoassay in development for the detection of IgG or IgA or IgM antibodies to SARS - CoV2 in human serum. These reagents are for in vitro diagnostic use only.
详细描述
The objective of this study is to acquire paired serum, plasma and whole blood collected on a collection card from subjects with no known history of COVID-19 infection. The specimens will be collected at Biomerica in Irvine CA for specimen collection, banking, and matrix equivalency studies for projects in development at Biomerica for detection to IgG or IgA or IgM antibodies to Sars-CoV2 antibodies. Subject will also be asked to self-collect a nasal swab for COVID-19 PCR
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 21 and older
- •Able to read, speak, and understand English
- •Must weigh a minimum of 110 pounds
- •Willing and able to donate 20 mLs of whole blood via venipuncture. [approximately ˂ 2 tablespoons]
- •Willing and able to donate 0.040 mLs of whole blood via fingerstick
- •Willing and able to sign the informed consent (self or authorized representative)
- •Willing and able to self-collect a nasal swab per the provided instruction shee
排除标准
- •Aged less than 21 years old
- •Unable to provide consent.
- •Unable to donate blood via venipuncture and fingerstick.
- •Unable to self-collect a nasal swab
结局指标
主要结局
Matrix Equivalency
时间窗: 1 day
This study is designed to collect specimens to support specimen matrix equivalency in an in vitro diagnostic assay for the detection of COVID-19 antibodies. Additionally, specimens collected via finger stick will be used to validate a whole blood collection card that could be used in the field by trained professionals and sent back to central reference laboratories for testing.
次要结局
未报告次要终点