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

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04468217
• Other study ID #: PRO-02
• Status: Recruiting
• Start date: June 2, 2020
• Est. completion date: September 25, 2020

Study information

• Verified date: July 2020
• Source: Neurognos
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 25, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID
• SARS-CoV2
• Severe Acute Respiratory Syndrome

Intervention

Diagnostic Test:
• Obtainment of nasopharyngeal, oropharyngeal, buccal, nasal and saliva samples
Each patient will undergo a sample collection where two nasopharyngeal samples will be obtained, one of them with lysis buffer as the transport medium and the other with the AAA-Safe solution as the transport medium. Oropharyngeal, buccal, nasal, and salivary samples will also be obtained using AAA-Safe as the transport medium

Locations

Country	Name	City	State
Chile	Laboratorio Neurognos	Santiago	Providencia

Sponsors (1)

Lead Sponsor	Collaborator
Neurognos

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of an alternative method of obtaining viral RNA for the detection of SARS-CoV-2 virus in nasopharyngeal samples.	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.	3 months
Secondary	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
Secondary	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