Evaluation of an Alternative Method of Obtaining Viral RNA for the Detection of SARS-CoV-2 Virus Using PCR
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Evaluation of an alternative method of obtaining viral RNA for the detection of SARS-CoV-2 virus in nasopharyngeal samples.
研究概览
简要总结
The current coronavirus disease pandemic has posed a problem and a challenge for health systems globally. In the framework of a pandemic, a diagnosis is a key tool in containing and monitoring disease outbreaks.
In this pandemic, the qPCR technique has become vitally important in virus detection, due to its wide detection and quantification range, and the high levels of sensitivity and specificity it presents. The methodology for diagnosing coronavirus by qPCR requires the prior extraction of viral genetic material, which is carried out using commercial kits created for this purpose. Currently, the high demand for supplies to carry out this technique has generated reagent shortage problems, including commercial kits for the extraction of viral genetic material.
This research aims to evaluate a solution called AAA-Safe and its method, developed to optimize the diagnostic process, eliminating and replacing the viral RNA extraction stage. We hope that this alternative can be implemented in any molecular diagnostic laboratory, in order to speed up the delivery of a fast and safe diagnosis.
详细描述
This analytical and non-interventional study will evaluate the performance of a new workflow for the detection of SARS-CoV-2 viral RNA from samples of nasopharyngeal, oropharyngeal, buccal, nasal and saliva mucosa using as transport medium the propietary AAA-Safe solution, in 150 volunteers in two different locations. The first sampling location will be held in a private clinic, where healthcare professionals will be enrolled. The second sampling location will be held at an essential services company, where samples will be taken by employees who voluntarily want to participate in the study.
All volunteers will be informed of all aspects of this protocol and must sign an informed consent before there participation. All the information associated with the samples requested will be duly anonymized in order to protect the identity of the volunteers.
The extracted samples will be processed and analyzed to obtain the detection limit of the diagnostic flow by implementing the developed solution and to establish the clinical performance in terms of sensitivity and specificity of the technique.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years and older
- •Volunteer able to understand and sign the informed consent
- •Healthcare professionals
- •Essential services company workers
排除标准
- •Older than 75 years
结局指标
主要结局
Evaluation of an alternative method of obtaining viral RNA for the detection of SARS-CoV-2 virus in nasopharyngeal samples.
时间窗: 3 months
Two workflows for the detection of SARS-CoV-2 will be compared: Gold Standard: Obtaining nasopharyngeal sample in validated transport medium, RNA extraction by columns and qPCR. Alternative method: Obtaining nasopharyngeal sample in AAA-Safe proprietary transport medium, alternative method of extraction and qPCR.
次要结局
- Evaluation of an alternative method of obtaining viral RNA for the detection of SARS-CoV-2 virus in oropharyngeal, nasal, buccal and saliva samples(3 months)
- Establish a sample bank of nasopharyngeal, oropharyngeal, nasal, buccal and saliva mucosa for future analytical validations of new solutions associated with the detection of the SARS-CoV-2 virus.(3 month)