COVID-19 Saliva Test Research Study
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

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.
    

Intervention name(s): Saliva and NPS test
Intervention type(s): Diagnostic Test
Intervention description(s): 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
Observational model: Cohort
Time perspective: Cross-Sectional
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.