COVID Clinical Trial
Official title:
Evaluation of an Alternative Method of Obtaining Viral RNA for the Detection of SARS-CoV-2 Virus Using PCR
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.
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.
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