About

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.


Webinars

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.


CPD

IBMS CPD credits can be gained at this event and both the webinars.

Twitter

Mobile App

Have you downloaded the MHRA Event App? Get the most out of the event by downloading the App to your smart phone or device. You will be sent the relevant event code and login details upon registering for the event. The App is available for both Apple and Android, just search 'MHRA Event App' or click on the appropriate link below:

Agendas

    The agenda for the SoGAT event in London at etc. venues Victoria

    11 - 12 June 2018

  • Registration and Networking


  • Welcome


  • Session One: Candidate materials and commutability

    Chair: Clare Morris

    • Impact of culture-derived changes in viral DNA sequences in WHO standards - Linda Cook, University of Seattle, USA
    • HCV IS replacement: investigating alternatives to HCV plasma - Jacqueline Fryer, NIBSC, UK
    • Lentiviral packaged RNA NAT standards as surrogates for high containment viruses - Mark Page, NIBSC, UK
    • Challenges with developing an Adenovirus International Standard - Jacqueline Fryer, NIBSC, UK
    • Commutability of the 1st IS for HDV RNA - Michael Chudy, PEI, Germany

     

    Session discussion

    • How much commutability is enough?
    • What Pre-establishment characterisation should be performed
    • When should pilot studies be used?


  • Lunch

     


  • Session Two: Molecular standardisation of Mycobacterium tuberculosis

    Chair: TBC

    • Update on revised need for standardisation - Sonia Arafah, FIND, UK
    • Development of a WHO IS and IRP for Mycobacterium tuberculosis NAT - Mei Mei Ho, NIBSC, UK


  • Session Three: Reference material assessment: understanding different molecular methods

    Chair: Neil Berry

    • Harmonising quantitative methods; the KRAS standards story - Jenny Boyle, NIBSC, UK
    • Role of dPCR as a method to support infectious disease detection - Jim Huggett, LGC, UK
    • Characterization of the NIST and WHO BKV standards by ddPCR - Megan Cleveland, NIST, USA
    • Antiviral Drug Resistance Testing for HIV-1, HBV, HCV and CMV - Experiences from INSTAND EQA - Heinz Zeichhardt, INSTAND, Germany
    • Standardisation in the absence of a standard - Bert Niesters, QCMD, UK

     

    Session discussion

    • Are current International standard formulations suitable for dPCR?
    • Are we striving for perfection when good is adequate?


  • End of Day One


  • Registration and networking


  • Session Four: When the IU changes - Statistical analysis and manufactures impact

    Chair: Jacqueline Fryer

     

    • 1st international standards - How the IU is derived - Kay-Martin Hanschmann, PEI, Germany
    • Statistical analysis for collaborative studies of replacement International Standards - Peter Rigsby, NIBSC, UK
    • Impact on manufacturers - manufacturers presentations

     

    Session discussion

    • Replacement international standards - How to select study participants
    • Should pre-evaluation and data analysis change


  • Refreshment Break


  • Session Five: Ask the experts

    Chair: TBC

    Technical discussion on materials to be presented to WHO Expert committee in 2018. 

    • 1st IS for HSV-1/2 DNA - NIBSC
    • 1st IS for Adenovirus DNA - NIBSC
    • 1st HIV p24 VLP IRP - NIBSC
    • 2nd IS for HIV-2 RNA - NISBC
    • 1st IS for anti-Zika - NIBSC


  • Lunch


  • Session Six: Case study - Molecular screening for human papillomaviruses

    Chair: Dianna Wilkinson

     

    Case Study - ENPEN - Non-polio enteroviruses

    Chair: TBC

    • Activities of the European non-polio enterovirus group - will standards help? - Heli Harvela, NHSBT, UK
    • Development of reference material multiplex controls and intentional standards

     


  • Closing remarks

     


  • Close


Venue

Etc Victoria


etc.venues Victoria
1 Drummond Gate
London
SW1V 2QQ
United Kingdom

etc.venues One Drummond Gate is situated right next to Pimlico tube station on the corner of Vauxhall Bridge Road and Drummond Gate.

By Underground

Pimlico - Victoria line
Exit the underground following the left hand exit marked Bessborough Street North and Tate Gallery. Drummond Gate is the white building to the left as you approach street level. Continue along and around Bessborough Street into Drummond Gate - One Drummond Gate is on the left.

Victoria – Victoria line
Exit via the main concourse onto Victoria Square or Wilton Rd (exit 2). Turn Left onto Wilton Road for approx 10 yards. Turn Right onto Vauxhall Bridge Road heading towards the river for approx 1000 yards. Turn right into Drummond Gate where the entrance to One Drummond Gate is found on your right.

By Rail

Victoria station is also served by main line overland trains. (see ‘By Underground’). Vauxhall Station is located at the opposite end of Vauxhall Bridge, and is about a 15 minute walk

By Road

On street metered car parking is available and the nearest car park can be found on Cumberland Street. Visit www.parkbcp.co.uk for further details.

By Bus

etc.venues One Drummond Gate sits on many bus routes including 2, 36, 185, 360, 439, C10.

Accommodation

Holiday Inn

Holiday Inn Express – Victoria
106-110 Belgrave Road, London, SW1V 2BJ

This hotel offers an ideal location for business and leisure. You will get complimentary breakfast and the site also has a relaxing bar to for the evening. There are also plenty of restaurants and bars in the surrounding local area.

Tel: +44 (0)207 630 8888

3 stars. Click here to view website.

Premier Inn - Victoria
82-83 Eccleston Square, London, SW1V1PS

Just moments from Victoria Station this hotel features 110 ideally located bedrooms. The hotel offers room service and the Thyme Restaurant on site. All rooms are en-suite and feature a double bed with TV and tea & coffee making facilities.

Tel: +44 (0)871 527 8680

3 stars. Click here to view website.

Premier Inn
Double Tree

DoubleTree by Hilton Hotel, Westminster
30 John Islip Street, London, SW1P 4DD

This hotel features a wide variety of luxury bedroom categories. The hotel has an excellent bar and restaurant onsite offering traditional meals in a very contemporary setting.

Tel: +44 (0)20 7630 1000

4 stars. Click here to view website.

Park Plaza - Victoria
239 Vauxhall Bridge Road, London, SW1V 1EQ

Featuring 299 air-conditioned guest rooms, wi-fi, a business centre, leisure suite and executive lounge all on site this hotel offers everything you need to both relax and conduct any work related activities without the usual stress of being away from home.

Tel: +44 (0)20 7769 9930

4 stars. Click here to view website.

Park Plaza

Register

London

from £100.00 INC VAT

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