Ignite Creation Date:
2024-05-06 @ 2:54 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04468217
Status:
UNKNOWN
Last Update Posted:
2020-07-13
First Post:
2020-07-09
Brief Title:
Evaluation of an Alternative Method of Obtaining Viral RNA for the Detection of SARS-CoV-2 Virus Using PCR
Sponsor:
Neurognos
Organization:
Neurognos
Study Overview
Official Title:
Evaluation of an Alternative Method of Obtaining Viral RNA for the Detection of SARS-CoV-2 Virus Using PCR
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None