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

NCT04468217 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2020-07-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Neurognos

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-02
Primary Completion
2020-09-15
Completion
2020-09-25

Countries

  • Chile

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04468217 on ClinicalTrials.gov