Standardisation of Genome Amplification Techniques and Serology/Standardisation of Infection Diagnostics (SoGATS/SID)
NIBSC and the SoGAT advisory group are pleased to announce the 28th International workshop on standardisation on 3-4 June 2019.
The 2-day meeting hosted at the MHRA headquarters in Canary Wharf, London, UK, will combine a series of expert lectures and round table discussions that address current challenges in the standardisation of molecular diagnostic assays.
Hot topics for 2019 will include:
This is a must attend event for anyone working in infectious disease diagnostics such as laboratory scientists, assay manufacturers, reference laboratories, EQA providers, and those in a regulatory setting.Confirmed speakers so far include expert representatives from NIBSC, Paul-Ehrlich-Institut, Public Health England.Book your place now by visiting: nibscsogats.co.uk/homeJoin the twitter conversation at #SoGAT19.For more information contact us at firstname.lastname@example.org
JC Virus DNA
Responsible scientist – Sheila Govind
This standard is now available from NIBSC; It is coded 14/114 and is available to order through the NIBSC catalogue.
BK Virus DNA
This standard is now available from NIBSC; it is coded 14/212 and is available to order through the NIBSC catalogue.
Responsible scientist - Dianna Wilkinson
Interim WHO standards for NAT are available to order through the NIBSC catalogue as follows: EBOV RNA NP-VP35-GP WHO Reference Reagent (NIBSC code 15/222), EBOV RNA VP40-L WHO Reference Reagent (NIBSC code 15/224). Further studies are underway to develop a WHO Ebola NAT International Standard.
Corresponding low-positive in-run controls for monitoring the analytical sensitivity of these assays are also available (NIBSC codes 15/136 and15/138.
An interim WHO standard is available from NIBSC; it is coded 15/220 and is available to order through the NIBSC catalogue. Further studies are underway to develop a WHO Ebola Antibody International Standard.
The collaborative study is now complete and data is now being analyzed. A copy of the report from this study will be sent to all participants by April 2017.
This study will be presented to the WHO Expert Committee on Biological Standardisation in October 2017. If you wish to know anything about this study, please email Sheila directly at email@example.com
Adeno virus DNA
A pilot study is has been completed to understand whether a single HAdV type can harmonize across all types. A type 2 tissue culture grown isolate has been selected to be taken forward as the main candidate in a collaborative study to establish an international standard. If you wish to register an interest in participating in this study please email Sheila directly at firstname.lastname@example.org
This study will be presented to the WHO Expert Committee on Biological Standardisation in October 2017.
HIV-1 p24 VLP panel
Responsible Scientist – Graham Prescott
This is a HIV-1 p24 antigen reference panel, consisting of non-infectious virus-like-particles (VLP).The VLPs contain subtype-specific structural Gag proteins cloned from patient RNA extracts. If you would like to participate in the study to evaluate this panel, please contact Graham directly at email@example.com by end February 2017.
Materials are currently being sourced for this study, if you have material that you would like to include please contact Arinder directly at firstname.lastname@example.org by end February 2017.
Materials are currently being sourced for this study, if you have material that you would like to include please contact Sheila directly at email@example.com by end February 2017.
Responsible scientist – David Padley
Materials are currently being sourced for this study, if you have material that you would like to include please contact David directly at firstname.lastname@example.org
4th HIV -1 RNA
A collaborative study is underway, data will be collated in February 2017 if you have any questions about the study please contact Graham directly at email@example.com.
3rd HAV RNA
Responsible scientist – Rehan Minhas
A collaborative study is underway, data will be collated in February 2017 if you have any questions about the study please contact Rehan directly at firstname.lastname@example.org
4th HBV DNA
Responsible Scientist – Jacqueline Fryer
Data from the collaborative study was presented to the WHO Expert Committee on Biological Standardisation in October 2016. The committee endorsed the establishment of this replacement standard. The replacement standard will be available to order by January 2017. If you have any questions about this study or ordering this material please contact Clare Morris at email@example.com.
This reagent is intended for blood screening laboratories to use in the internal laboratory quality control of NAT assays for HBV, HCV and HIV-1. The reagent is intended to be included in each run as part of a continuing quality control program to monitor the assay performance. This reagent is not intended for any calibration purposes. It is coded 14/198 and is available to order through the NIBSC catalogue.
In 1994, the European Plasma Fractionation Association (EPFA), in conjunction with NIBSC, held a workshop to discuss the potential applications of NAT; from the detection of blood borne viruses in blood donation screening, to the production of “clean” plasma derived products. The meeting concluded that there was a need for standardization of NAT in the blood safety field, and that this warranted the formation of a group dedicated to standardization of NAT-based assays for blood borne viruses.
The 1st meeting of the International Working Group on the Standardisation of Genomic Amplification Techniques (SoGAT) for the virological safety testing of Plasma and Blood derived Products took place in April 1995. The group met to discuss standardisation techniques for blood viruses such as HCV, HBV, B19 as well as HIV. The rapid development of commercial assays for NAT and the appreciation of the scope of this new technology by many diagnostic and research laboratories, led to a decision that there was a need for reference materials for blood borne viruses.
Since 1994 the group have been paramount in the development of International Standards, reference panels and working reagents for HIV-1 RNA, HAV RNA, HCV RNA, HBV DNA and B19V DNA. Today, the group continues to support the development of new and replacement standards and reference panels and exchange information relevant to the scientific, technical and regulatory aspects of NAT.
Using the experience and knowledge gained by the SoGAT group focusing on blood virology, a new SoGAT group was established to address the area of clinical virology, which remains largely unstandardised. The International SoGAT Clinical Diagnostics Working Group is focused on the standardisation of NAT assays used in the diagnosis of clinical pathogens. The group was established in parallel to the SoGAT Blood Safety Working Group in 2008 and the first meeting took place at NIBSC in June of that year. The group has supported the development of International Standards for HCMV, EBV, BK and JC viruses for NAT, and new projects for adenovirus and HHV-6 NAT standardisation.
Since 2013, the SoGAT blood and clinical groups have met at an annual joint workshop. Participation is encouraged from blood and clinical laboratories, manufacturers of diagnostic assays and quality control reagents, providers of external quality assessment schemes, and regulatory and public health authorities.
The use of serological screening as a means of detecting viral infection has been in use since the early 1970’s and has been fundamental in diagnosis and monitoring of infection. The advent of NAT, described above, somewhat over shadowed the use of serology assays for a number of years, however serological screening still plays an important role in understanding the disease state. Serological tests are often less expensive compared to NAT and are therefore the test of choice for resource limited settings.
Many serological standards were developed to support the batch release of vaccines and are used conjunction with European Pharmacopeia monographs. However, greater understanding of the need to ensure comparability of diagnostic data has led to the increased use of the serological standards in the calibration of diagnostic assays. These standards however were those that were originally developed for vaccine release and are not necessarily suitable for diagnostic assay calibration.
In 2014 the SoGAT group raised the question - which forums are currently addressing standardisation of serology assays? To which the answer was very few, if any. Applying the experienced gained by running meetings to standardise NAT, it was decided that a new branch to the SoGAT meeting would be formed – SoGAT Serology.
SoGAT Committee members
Fast track diagnostics
VIRPATH Laboratory, France
Philip Minor (Chair)
Lelie consulting, France
University Hospital Leuven, Belgium
Philip Minor (chair)
VUmc, The Netherlands
NHS Lothian, UK
GFE Blut, Germany
UMCG, The Netherlands