COVID-19 Saliva Test Research Study

COVID-19 Saliva Test Research Study - Evaluation of High Throughput COVID-19 Testing Via Saliva Based Sampling and Alternative RNA Extraction Methods.

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?

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: Saliva and NPS 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.

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• United Kingdom
  • Gloucester, United Kingdom
    • Gloucestershire Royal Hospital
  • Salford, United Kingdom
    • Salford Royal NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 117 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Study is being conducted at specific hospitals so will apply geographically to people within the eligibility criteria as described above.

Description

Site 1: Testing on Admission approach Inclusion Criteria Individuals suspected to have COVID-19 who were admitted to Gloucestershire Hospitals NHS Foundation Trust facilities for treatment for COVID-19. Individuals with full mental capacity.

Exclusion Criteria None

Site 2: Positive Matching approach Inclusion Criteria Individuals tested positive for COVID-19 at Northern Care Alliance NHS Group using an NHS NPS test who are accessible within 24 hours and consent to providing a saliva sample and further NPS sample for Chronomics.

Exclusion Criteria Individuals who have not tested at all or have not tested positive.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients suspected to have Covid-19; Individuals suspected to have COVID-19 who are admitted to Gloucestershire Hospitals NHS Foundation Trust facilities for treatment for COVID-19. Individuals with full mental capacity.	Diagnostic test: Saliva and NPS test; N/A Our study will not impact their path of care as they will be doing an NHS test which will determine their path of care at the NHS
Patients tested positive for Covid-19; Individuals tested positive for COVID-19 at Northern Care Alliance NHS Group using an NHS NPS test who are accessible within 24 hours and consent to providing a saliva sample and further NPS sample for Chronomics.	Diagnostic test: Saliva and NPS test; N/A Our study will not impact their path of care as they will be doing an NHS test which will determine their path of care at the NHS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test Result	Positive / Negative / Indeterminate	Within 2 weeks of sample collection

Collaborators and Investigators

• Sponsor: Chronomics Limited

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 283560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes