SoGATS Workshop 2023

Wednesday 4 - Friday 6 October 2023

Congress Centre, London


SoGATs (Standardisation of Genome Amplification Techniques and serology) is an international forum to discuss and shape scientific strategies for the development of reference materials that harmonise the performance of molecular and serological diagnostic assays for infectious diseases.

The event is targeted at laboratory scientists, assay manufacturers, reference laboratories, EQA providers and regulators in the field of infectious disease diagnostics.

The format of the meeting is designed to provide plenty of time for discussion by participants following a series of scientific presentations on topics related to each sessions’ theme.

By the end of the meeting delegates will:

  • Have an understanding of the scientific challenges in the accurate calibration of molecular and sero-diagnostic assays for infectious diseases that harmonise measurement within and between laboratories.
  • Understand the benefits and limitations of applying the principles of biological standardisation in the development of calibrators for molecular and serodiagnostic assays for infectious disease.


The programme will explore the following themes:

  • Pandemic response: lessons learned and preparing for the next pandemic
  • Update on WHO reference materials
  • Current challenges for clinical infectious disease diagnostics
  • Measuring serological responses in infectious disease
  • What does it take to make digital PCR a reference method?
  • What reference materials are required to assure NGS as a routine diagnostic  



Please note agenda timings are subject to change.

Day 1 - 4 October — full schedule

October 4th, 11:00 - 17:00

Welcome - Workshop Objectives

Neil Almond — SoGAT Chair

Session 1: Pandemic response: lessons learned

Chairs: Heinz Zeichhardt and TBC

Emerging virus reference materials: the pros and cons of VLPs and inactivated viruses
  • Emma Bentley — MHRA, UK
The value of EQA schemes in the early stages of an outbreak with a novel pathogen
  • Martin Kammel — INSTAND, Germany
Responding to more recent emergencies: Mpox and Flu A
  • Jacqueline Fryer — MHRA, UK


Session 1: Pandemic response: preparing for the next pandemic

Chairs: Heinz Zeichhardt and TBC

Evaluating “measurement capacity” in future outbreaks: the CCQM/NAWG ‘fire drill’
  • Denise O’Sullivan — LGC-NML, UK
Pandemic Influenza – assuring early detection on a new zoonotic infection
  • Jade Cogdale — UKHSA, UK
Discussion: Critical appraisal of pandemic responses; what did we learn?

1. How could SoGAT have supported the diagnostic community better?

2. How can SoGAT support manufacturers to meet WHO TPP’s?

3. What should SoGAT do to share this learning?


Session 2: Update on Projects to produce WHO Reference Materials

Chairs: Jacqueline Fryer and Neil Almond

The candidate 2nd WHO IS for SARS-CoV-2 RNA
  • Emma Bentley — MHRA, UK
Update on new and ongoing WHO projects
  • Jacqueline Fryer — MHRA, UK
  • Heinrich Scheiblauer — PEI, Germany
  • David McGivern — CBER, USA
Discussion: Setting priorities for new/replacement WHO references

1. Feedback from SoGAT on the data presented above.

2.  What are SoGAT’s views on the prioritisation of current and future projects to prepare new reference materials?

End of Day 1

Day 2 - 5 October — full schedule

October 5th, 09:00 - 17:00

Welcome - Overview of Day 1

Neil Almond — SoGAT Chair

Session 3: Current challenges for Assuring the Quality of Clinical Infectious Disease Diagnostics

Chairs: Heinz Zeichhardt and TBC

TB diagnostics
  • Tarak Shah — FIND
The 1st WHO IS for Mycobacterium Tuberculosis (H37Rv) DNA for NAT-based assays
  • Mei Mei Ho — MHRA, UK
The evolving challenges of quality assurance in HPV testing for screening, diagnosis and prognostication
  • Kate Cuschieri — Scottish HPV Reference Laboratory, UK
HPV EQA and QC performance
  • Wayne Dimech — NRL Quality, Australia
SARS-CoV-2 Ag tests – evaluation of test performance in Australia Joe Vincini, NRL Quality, Australia
  • Wayne Dimech — NRL Quality, Australia
SARS-CoV-2 Ag tests – evaluation of test performance in Europe
  • Heinrich Scheiblauer — PEI, Germany
Discussion: Title TBC

1.  Where next with TB diagnostic reference materials?

2.  HPV International Standards and Working Standards – Purpose utility and confusion?

3.  What makes the ideal reference preparation? 


Session 4: Measuring serological responses in infectious disease

Chairs: Joe Vincini and Neil Almond

WHO manual on calibration of secondary antibody references
  • Giada Mattiuzzo — MHRA, UK
WHO discussion on setting IU and BAU
  • Elwyn Griffiths — WHO consultant
View from EQA on value of BAU
  • Heinz Zeichhardt — INSTAND, Germany
Discussion: Units – what units and why?


Session 4: continued

Chairs: Joe Vincini and Neil Almond

Project to replace WHO International Standard for anti-Rubella Ig
  • Sarah Kempster — MHRA, UK
Should we be calibrating serological diagnostic assays at all?
  • Wayne Dimech — NRL Quality, Australia
Correlates of protection and calibrating assays
  • Stanley Plotkin — Vaxconsult, USA


Session 4: continued

Chairs: Joe Vincini and Neil Almond

Discussion: Do serological assays ever need calibrating?

1. When?

2.  How?                                                                                                              

End of Day 2

Day 3 - 6 October — full schedule

October 6th, 09:00 - 15:30

Welcome - Overview day 2

Neil Almond — SoGAT Chair

Session 5: What does it take to make dPCR a reference method?

Chairs: Megan Cleveland and Neil Almond

What is a metrologists view of a reference method – how does this apply to digital PCR
  • Jim Huggett — LGC-NML, UK
Demystifying Digital PCR: Debunking Misconceptions and Maximizing Digital PCR Results
  • Megan Cleveland — NIST, USA
Establishing a digital PCR for CMV as a reference method
  • Mojca Milavec — NIB, Slovenia
Analysis of wastewater by genome amplification methods – the role of reference materials Javier Martin, MHRA, UK
  • Javier Martin — MHRA, UK
Discussion: Does dPCR need reference materials to assure the quality of assays?

1.  Is dPCR a reference method?  What is needed to establish it as such?

2.  What do we need to do to educate clinicians on the strengths and limitations of dPCR?


Session 6: Assuring the quality of NGS as a clinical service

Chairs: Albrecht Gröner and Jim Huggett

NGS as a clinical service
  • Julianne Brown — GOSH, UK
Considerations on introducing NGS into the diagnostic screening of blood
  • Heli Harvala-Simmonds — NHSBT, UK
NGS monitoring of virus drug resistance and control materials
  • Tamyo Mbisa — UKHSA, UK


Session 6: NGS as a routine diagnostic

Chairs: Albrecht Gröner and Jim Huggett

Data Standards and Reference Materials
  • Ravneet Bhuller — MHRA, UK
The value of NIBSC 11/242 and considerations for replacement/improvement
  • Peter Simmonds — University of Oxford, UK
ICH Q5A guideline
  • Albrecht Gröner — PathoGuard, Germany
Discussion: Title TBC

1.  What are the problems encountered when delivering NGS as a clinical service?

2.  How do you meet accreditation when trying to apply NGS as a clinical service?

3.  What reference materials are needed to underpin the service?

4.  How can you prepare reference materials for detecting unknown pathogens?

Summary and action plans

Neil Almond — SoGAT Chair

Close of workshop


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Photo by Allie on Unsplash



3 minute walk from Tottenham Court Road Underground Station

Short walk from Oxford Street and Covent Garden

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