Evaluation of an Alternative Method of Obtaining Viral RNA for the Detection of SARS-CoV-2 Virus Using PCR

Neurognos

Status: Unknown

Conditions: Corona Virus Infection; COVID; SARS-CoV2

Treatments: Diagnostic Test: Obtainment of nasopharyngeal, oropharyngeal, buccal, nasal and saliva samples

Study type: Observational

Funder types: Industry

Identifiers

NCT04468217

PRO-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years and older
• Volunteer able to understand and sign the informed consent
• Healthcare professionals
• Essential services company workers

Exclusion criteria

• Older than 75 years

Trial design

150 participants in 2 patient groups

Subjects with positive test to SARS-COV2

Description:

Employees of critical services companies and healthcare workers with a positive test to SARS-COV2.

Treatment:

Diagnostic Test: Obtainment of nasopharyngeal, oropharyngeal, buccal, nasal and saliva samples

Subjects with negative test to SARS-COV2

Description:

Employees of critical services companies and healthcare workers with a negative test to SARS-COV2.

Treatment:

Diagnostic Test: Obtainment of nasopharyngeal, oropharyngeal, buccal, nasal and saliva samples