An observational study in Covid19, sponsored by Chronomics Limited. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 117 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-28.
Sponsored by Chronomics Limited · Observational
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?
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 400 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Chronomics Limited as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Study is being conducted at specific hospitals so will apply geographically to people within the eligibility criteria as described above.
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.
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
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
Test Result
Positive / Negative / Indeterminate
Time frame: Within 2 weeks of sample collection
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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