NIBSC are pleased to announce two events in the Standardisation of Genomic Amplification Techniques (SoGAT) programme. The first, on 11 and 12 June will be our 27th International SoGAT workshop, which will be held in central London. Keep an eye on this page for details of two webinars, the first of which will be a guide to the development and uses of different control materials that assure the quality of molecular diagnostic assays for infectious diseases.
Standardisation of Genomic Amplification Techniques Workshop
This year’s workshop will combine lectures from experts and round table discussions that address the challenges in standardisation of molecular diagnostic assays. The workshop format will encourage discussion and networking, providing delegates with the opportunity to share their experiences and exchange ideas in a collaborative style.
Agenda, presentation content and topics of discussion
In previous years WHO collaborating centres have used the SoGAT meeting as a forum to discuss data from collaborative studies to establish WHO international standards. However, we recognise that for meaningful discussion delegates often need time to review data, therefore new this year we have introduced a session called ‘Ask the Experts’. A week in advance of the meeting, presentations of each study that will be presented to WHO at their annual standardisation meeting in October, will be placed on the Microsite – these will only be available to registered delegates, so book your place to access these! During the meeting we will be discussing pertinent data from these studies and inviting all to bring their questions.
Key to the meeting, is to keep looking forward and asking the question, ‘where can clinical impact be improved by the provision of standards and reference materials?’ This year we will focus on three case studies and the move to use molecular diagnostic methods – Human Papillomavirus, Mycobacterium tuberculosis and the growing field of non-polio enteroviruses, experts from these fields will be outlining new challenges in diagnostics following by discussion on how the SoGAT group can assist with standardisation.
Identifying suitable source materials can be one of the most challenging parts of developing reference standards, material must be of a suitable volume with sufficient titre to allow for appropriate dilution to create supply for a good number of years, typically > 10. Clinical material, whilst the most obvious and suitable choice is not always available. Sourcing suitable alternatives will be discussed along with the different ways of assessing these for commutability – understanding the likeness of laboratory derived candidate materials to clinically sourced patent material.
For over 20 years PCR has become ever more used as an analytical technique and is, still, at the forefront of diagnostic testing, however new technologies such as digital PCR are beginning to feature. We will look more in-depth at how this technology is being used and in addition whether a single standard can be used to harmonise data across multiple methodologies.
During our statistical analysis session, we will focus on two main themes. Firstly, how the International unit is derived when a standard is established for the first time and secondly, using examples from previous studies such as HCV and B19, we will understand the considerations that need to take place for IU continuity. We understand that changing batches of International standard can cause concerns for manufactures and we encourage all manufactures to join the discussion that will take place after these talks.
Who should attend
This is an international event and is aimed at laboratory scientists, assay manufacturers (not just qPCR assays but also point of impact tests, NGS and dPCR) Reference Laboratories, EQA providers, to those in a regulatory setting.
For the first time NIBSC will be hosting two webinars throughout 2018 and 2019 addressing different aspects of standardisation, further details will be available shortly.
IBMS CPD credits can be gained at this event and both the webinars.