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

NCT04468217 | Unknown

• 1 other identifier: PRO-02
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID; SARS-CoV2; Corona Virus Infection

Keywords

SARS-CoV-2; Diagnostics; RNA Extraction; COVID

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Subjects with positive test to SARS-COV2

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

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

Subjects with negative test to SARS-COV2

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

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

Interventions

Obtainment of nasopharyngeal, oropharyngeal, buccal, nasal and saliva samples DIAGNOSTIC_TEST

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

Subjects with negative test to SARS-COV2; Subjects with positive test to SARS-COV2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Two groups can be identified within the study population: * The first group are health professionals (nurses, doctors, kinesiologists, etc.) who are working in healthcare centers during the current pandemic. * The second group are employees of an essential services company.

You may qualify if:

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

You may not qualify if:

• Older than 75 years

Sponsors & Collaborators

• Neurognos: lead

Study Sites (1)

Laboratorio Neurognos

Santiago, Providencia, 7500000, Chile

RECRUITING

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 13, 2020
• Study Start: June 2, 2020
• Primary Completion: September 15, 2020
• Study Completion: September 25, 2020
• Last Updated: July 13, 2020

Record last verified: 2020-07

Locations

CL (1)