Clinical Agreement Study of 'TekiTrustTM SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit' and 'TekiTrustTM SARS-CoV-2 Neutralizing Antibody Detection Rapid Test'
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 218
- 试验地点
- 3
- 主要终点
- Clinical agreement between TekiTrust SARS-CoV-2 Neutralizing Antibody ELISA Kit and Rapid Detection test and the comparator PRNT assay.
研究概览
简要总结
The purpose of this study is to determine if the TekiTrust Enzyme-Linked Immunosorbent Assay (ELISA) Kit and TekiTrust Rapid Test can accurately determine the amount of antibodies to fight the COVID-19 virus in sampled blood compared to the standard Plaque Reduction Neutralization Test (PRNT) test.
When a person has COVID-19 they develop antibodies to the virus which are contained in their blood stream. After a certain period, the number of antibodies to fight (neutralize) the virus begin to decrease. One common way to measure the amount of antibodies in the blood is to use a test called the PRNT. The focus of this study is to compare the ability of the TekiTrust ELISA Kit and the TekiTrust Rapid Test with the PRNT to determine if these tests can measure the antibodies equally well.
详细描述
Participants who have been previously diagnosed with COVID-19 within the past 3 months through any FDA emergency use approved (EUA) assay test will eligible for inclusion in the study. A blood and fingerstick sample will be obtained from the participant and for subjects with a positive test and symptom onset of less than 30 days a repeat RT-PCR nasal pharyngeal swab sample will be taken. The fingerstick sample will be used onsite by qualified site staff to test the TekiTrust SARS-CoV-2 Neutralizing Antibody Detection Rapid Test. These results will be compared to the whole blood sample sent to the lab which will be analysed for SARS CoV-2 neutralizing antibodies using the TekiTrust SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit and the comparator Plaque Reduction Neutralization Test (PRNT) test.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •≥ 18 years of age
- •Able and willing to provide written informed consent
- •Previously diagnosed as SARS-CoV-2 positive by any FDA EUA approved assay with a symptom onset date within the previous 30 days and who are willing to provide a nasopharyngeal swab for RT-PCR testing
- •Suspected of previous SARS-CoV-2 infection and willing to provide a nasopharyngeal swab for RT-PCR testing
- •Previously diagnosed as SARS-CoV-2 positive by a FDA EUA approved RT-PCR assay with a symptom onset date greater than 30 days and a known date of PCR sample collection and symptom severity
排除标准
- •Any significant medical, psychological, or social condition which in the opinion of the investigator may preclude the subject from participating in the trial
结局指标
主要结局
Clinical agreement between TekiTrust SARS-CoV-2 Neutralizing Antibody ELISA Kit and Rapid Detection test and the comparator PRNT assay.
时间窗: Day one
1. PPA (Sensitivity) between ≥87% with a lower bound of the 95% confidence interval greater than 74.4% 2. NPA (Specificity) ≥ 93% with a lower bound of the 95% confidence interval greater than 87.8%
次要结局
- Safety endpoint: adverse events(Single study visit)