Sero-survey of COVID19 antibodies

• Research type

  Research Study

• Full title

  Sero-survey of COVID19 antibodies (IgA, IgM and IgG) and their correlation with new or exacerbated neurological presentations in children admitted to the paediatric wards at Chelsea and Westminster Hospital.

• IRAS ID

  290189

• Contact name

  Damon Foster

• Contact email

  Damon.Foster@chelwest.nhs.uk

• Sponsor organisation

  Research and Development Department

• Duration of Study in the UK

  0 years, 8 months, 0 days

• Research summary

  There was a 3-fold increase in admission of children with new/exacerbated neurological conditions to Chelsea and Westminster Hospital (CWH) in March-June 2020 (in comparison to the similar time period in the last years). Majority of patients’ SARS-CoV2 (COVID-19) PCR tests (from throat swabs) were negative.

  Our hypotheses are that:
  - COVID-19 infection is a triggering and a contributing factor in neurological disorders.
  - Throat PCR is not a reliable test (timing and techniques of sample collections are very crucial) and does not identify previous exposure to COVID-19.
  - There is a correlation of antibody classes and its titres with severity of neurological disorders. This correlation is very vital for an appropriate targeted treatment

  It is essential to find a simple, prompt and reliable test to establish exposure of COVID-19 in children with neurological conditions. If an antigen used in a test does not have the right structure/conformation, it will not be recognised by specific antibodies making the test unsuitable. Currently, NHS uses Roche Elecsys® test which demonstrated 83.9% sensitivity (claimed 100%) and hasn’t included specific negative samples in their assay validation like SARS, MERS and other common colds.

  Daresbury Proteins Ltd developed and validated a unique COVID-19 sero-assay, which provides extremely specific quantification of antibody titres for each antibody class. It is significantly more reliable and informative than Roche’s Elecsys® test.

  Proposed solution:
  - To collect serum +/- CSF samples from children with new/exacerbated neurological conditions admitted to CWH. Some samples were collected as a standard care in March–June 2020 and stored in our laboratory.
  - To conduct a pioneering sero-survey for COVID-19 antibodies and their titres using highly sensitive ELISA approach
  - To correlate classes of serum antibodies with CSF ones in the same patients
  - To correlate antibodies with dynamics of neurological signs /symptoms.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  20/HRA/5688

• Date of REC Opinion

  24 Nov 2020

• REC opinion

  Unfavourable Opinion