CTRI/2020/07/026759已完成不适用
Evaluation and Validation of the clinical performance of VITROS Anti SARS COV2 Total assay in the COVID-19 patient population and commercialization of the Assay on VITROS 3600
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Identifying individuals with an adaptive immune response to SARS-CoV-2 infection.
研究概览
简要总结
The data generated will help in:
Identifying individuals with an adaptive immune response to SARS-CoV-2 infection.
To evaluate the positive percent agreement (PPA) of the serological assay in comparison with the currently in use RT PCR assay
To evaluate the PPA of the serological assay in symptomatic patients of Covid-19 (SARS CoV2 RT PCR Positive), when the sample was collected post 8 days from the onset of symptoms.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Covid 19 RT PCR positive patients having typical symptoms for about a minimum of 8 days will be assayed using VITROS® CoV2T assay in VITROS® 3600 or 5600 systems.
- •Asymptomatic health care professionals, will be tested using VITROS® Anti SARS CoV2 Total assay on the VITROS® 3600 Immunodiagnostics or VITROS® 5600 Integrated System.
- •Samples from normal healthy adult asymptomatic individuals (collected before Nov., 2019) will be tested using VITROS® Anti SARS CoV2 Total assay on the VITROS® 3600 Immunodiagnostics or VITROS® 5600 Integrated System.
排除标准
- •Exclude samples from patients for whom the time between symptom onset and collection of samples cannot be determined.
- •Exclude grossly hemolyzed, icteric or turbid samples, or samples with visible particulates that are not getting removed even after centrifugation.
结局指标
主要结局
Identifying individuals with an adaptive immune response to SARS-CoV-2 infection.
时间窗: Covid 19 RT PCR positive patients having typical symptoms for about a minimum of 8 days will be assayed. Titres at 8th day will be considered as baseline data
次要结局
- To evaluate the positive percent agreement (PPA) of the serological assay in comparison with the(currently in use RT PCR assay)
研究者
研究点 (1)
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