Ignite Creation Date:
2024-05-06 @ 3:07 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04531501
Status:
COMPLETED
Last Update Posted:
2022-07-28
First Post:
2020-08-26
Brief Title:
COVID-19 Saliva Test Research Study
Sponsor:
Chronomics Limited
Organization:
Chronomics Limited
Study Overview
Official Title:
COVID-19 Saliva Test Research Study - Evaluation of High Throughput COVID-19 Testing Via Saliva Based Sampling and Alternative RNA Extraction Methods
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
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 objective of this study is to compare the Chronomics test against the NPS tests and protocol currently in use to demonstrate the efficacy of Chronomics approach The principal question is Does the Chronomics saliva based test perform as well as the NPS NHS test
Detailed Description:
In December 2019 a novel coronavirus caused an outbreak in Wuhan China Just a month later Covid-19 was declared a Public Health Emergency of International Concern on 30 January 2020 The World Health Organisation WHO repeatedly announced that Diagnostic testing for COVID-19 is critical to tracking the virus understanding epidemiology informing case management and to suppressing transmission The priority within Public Health England PHE was to scale up public health testing using molecular diagnosis through real-time RT-PCR RdRp gene assay based on oral swabs
Some of the key challenges publicly presented regarding testing are speed of mobilisation supply chain issues due to the international demand for crucial testing materials like kits swabs and chemical reagents and the quality and comfort of the nasopharyngeal NSP swabs commonly used
Chronomics has developed novel methods to address these problems Firstly due to the shortage of the specific branded reagent products used in the official CDC FDA EUA COVID-19 RT-qPCR protocol for RNA extraction Chronomics have sourced and compiled testing of components to create an extraction kit with greater availability of supply for use within the protocol Secondly Chronomics methods are based on saliva collection which are pain-free and easy to collect
The objective of this study is to compare the Chronomics test against the NPS tests and protocol currently in use to demonstrate the efficacy of Chronomics approach The principal question is Does the Chronomics saliva based test perform as well as the NPS NHS test There are two components of Chronomics testing framework that the investigators are looking to validate to feed into this Firstly that Chronomics alternative reagents and workflow RNA-extraction and RT-PCR steps do not impact sensitivity of detection and secondly that Chronomics alternative sampling source of saliva also does not impact sensitivity of detection To achieve validation of these two components the investigators will compare both a Chronomics saliva sample vs an NHS NPS sample and a Chronomics NPS sample vs an NHS NPS sample The investigators would require access to the output and information as to the linked patient for the NHS gold-standard workflow
Some of the key challenges publicly presented regarding testing are speed of mobilisation supply chain issues due to the international demand for crucial testing materials like kits swabs and chemical reagents and the quality and comfort of the nasopharyngeal NSP swabs commonly used
Chronomics has developed novel methods to address these problems Firstly due to the shortage of the specific branded reagent products used in the official CDC FDA EUA COVID-19 RT-qPCR protocol for RNA extraction Chronomics have sourced and compiled testing of components to create an extraction kit with greater availability of supply for use within the protocol Secondly Chronomics methods are based on saliva collection which are pain-free and easy to collect
The objective of this study is to compare the Chronomics test against the NPS tests and protocol currently in use to demonstrate the efficacy of Chronomics approach The principal question is Does the Chronomics saliva based test perform as well as the NPS NHS test There are two components of Chronomics testing framework that the investigators are looking to validate to feed into this Firstly that Chronomics alternative reagents and workflow RNA-extraction and RT-PCR steps do not impact sensitivity of detection and secondly that Chronomics alternative sampling source of saliva also does not impact sensitivity of detection To achieve validation of these two components the investigators will compare both a Chronomics saliva sample vs an NHS NPS sample and a Chronomics NPS sample vs an NHS NPS sample The investigators would require access to the output and information as to the linked patient for the NHS gold-standard workflow
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None