Evaluation of Roche combined SARS-CoV-2 IgM/IgG assay [COVID-19]

• Research type

  Research Study

• Full title

  Evaluation of Roche combined SARS-CoV-2 IgM/IgG assay

• IRAS ID

  286435

• Contact name

  Mark Hopkins

• Contact email

  mark.hopkins2@nhs.net

• Sponsor organisation

  Barts Health NHS Trust

• Duration of Study in the UK

  0 years, 3 months, 1 days

• Research summary

  Research Summary
  METHODS:

  - Collect serial serum samples from inpatients with PCR confirmed Covid-19 infection
  - Review clinical records to find date of onset of symptoms
  - Test all available serial samples for SARS-CoV-2 antibody using the Roche combined SARS-CoV-2 IgM/IgG assay
  - Present data in anonymised summary form

  AIMS/OBJECTIVES:

  - To complete a verification exercise for the commercial (Roche) assay allocated to our lab after PHE evaluation
  - To describe what proportion of confirmed Covid-19 seroconvert
  - To describe at what stage in illness seroconversion is seen
  - To see if there is any evidence of waning of antibody level after a longer (but limited) period of follow up

  Summary of Results

  The Roche Elecsys anti-SARS-CoV-2 and the Abbott SARS-CoV-2 IgG assay both had 100% specificity.

  •Overall sensitivity of the Roche assay was 92.1% at ≥14 days and 94.8% at ≥21 days, and the overall sensitivity of the Abbott assay was 94.4% at ≥14 days and 98.2% at ≥21 days.

  •Low rates of seroconversion seen in the immunocompromised (95.2% vs. 81.0% sensitivity at ≥21 days).

  •Sensitivity in the immunocompromised was numerically higher with the Abbott assay.

  •After excluding samples from immunocompromised patients sensitivity of both assays appeared excellent (100% for both assays at ≥21 days.

  •Short-term antibody waning was demonstrated with both assays.

  •Seroreversion was seen with the Roche assay.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  20/HRA/4356

• Date of REC Opinion

  10 Sep 2020

• REC opinion

  Favourable Opinion