standardising nat for clinical targets through sogat clinical diagnostics jacqueline fryer
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Standardising NAT for clinical targets through SoGAT Clinical Diagnostics Jacqueline Fryer. Molecular Diagnosis of Clinical Pathogens. Many NAT assays developed in-house, methodology varies significantly QC reagents often developed in-house, e.g. plasmids (not extracted) - PowerPoint PPT PresentationTRANSCRIPT
National Institute for Biological Standards and ControlAssuring the quality of biological medicines
Standardising NAT for clinical targets through SoGAT Clinical
Diagnostics
Jacqueline Fryer
Molecular Diagnosis of Clinical Pathogens
• Many NAT assays developed in-house, methodology varies significantly
• QC reagents often developed in-house, e.g. plasmids (not extracted)
• Lack of standardised reference reagents (except for BBV) makes it difficult to compare performance and develop uniform patient management algorithms
• Results from EQA programmes and other studies indicates variability in performance of testing, and highlights need for standardisation
NIBSC/HPA/CVN Working Reagents
Organism No. data points
Mean Ct ± 2SD
Range (Ct)
Influenza A (H1) 252 31.29 ± 5.24 25.30 - 40.66
Influenza A (H3) 238 30.33 ± 5.40 24.30 - 37.88
Influenza B 265 28.14 ± 4.55 22.46 - 36.75
Norovirus 483 33.17 ± 9.00 23.00 - 44.03
HSV1 272 28.91 ± 7.72 18.73 - 39.23
HSV2 267 29.43 ± 6.27 20.83 - 39.00
HCMV 240 29.28 ± 5.51 24.87 - 37.40
EBV 139 28.03 ± 8.82 17.28 - 36.56
Aims of SoGAT Clinical Diagnostics
• To plan and coordinate the development, evaluation and provision of reference reagents, International Standards and reference panels for qualitative and quantitative NAT assays for a range of clinical diagnostics
• To exchange information on the technical and scientific aspects of NAT assays for clinical diagnostics, between professionals in:
– Diagnostic and reference laboratories, – Manufacturers of diagnostic kits and reagents, – External Quality Assessment (EQA) providers– Public health and regulatory authorities
• To assist in the development of regulatory approaches
• To provide support for new technologies, e. g. multiplex nucleic acid assays, micro-arrays.
SoGAT Clinical Diagnostics I
• First meeting held 24th/25th June 2008• NIBSC, UK• Chaired by Dr Philip Minor (NIBSC)
Session 1: Welcome address /Introduction to Clinical Diagnostics
Clinical NAT Bill Carman, West of Scotland Specialist Virology Centre, UK
Clinical Microbiology and Infection Control Brian Duerden, Department of Health, UKSession 2: Standardisation and aims of SoGAT
Aims of SoGAT and role of NIBSC Philip Minor, NIBSC, UK
Standardisation: calibration of International Standards, reference materials and working standards Micha Nübling, PEI, Germany
Experience with Standardisation of blood virology NAT Clare Morris, NIBSC, UK
Session 3: Standardisation for clinical diagnostics: part 1
WHO Collaborative Study to Establish WHO International Standards for Human Papillomavirus (HPV) Type 16 DNA and HPV Type 18 DNA Nucleic Acid Amplification Technology (NAT)-Based Assays Dianna Wilkinson, NIBSC, UKDevelopment of clinical virology working standards for NAT Anna Gottlieb, NIBSC, UKNAT Quality control for Chlamydia trachomatis (and Neisseria gonorrhoea) Joe Vincini, HPA, UK Discussion on frequency of SoGAT Diagnostics Meetings and Aims
SoGAT Clinical Diagnostics I Programme - Day 1
Session 4: Standardisation for clinical diagnostics: part 2
MRSA - Practical aspects of standardization for a global controls manufacturer Frank Opdam, Acrometrix, USAControls for Chlamydia trachomatis and Neisseria gonorrhoea Mark Manak, SeraCare, USA Standardization of full process nucleic acid testing controls Peter Trabold, ZeptoMetrix Corporation, USA Session 5: Assessment of laboratory performance and Calibration of EQAS panels
UK NEQAS schemes for CMV, HPV and mycobacteria Vivienne James, HPA, UK QCMD molecular EQA past, present, and future Paul Wallace, QCMD, UK
Session 6: Standardisation of CMV and EBV viral loads
Viral dynamics and the importance of viral load measurements in the management and prevention of HCMV disease Vincent Emery, Royal Free and University College Medical School, UK
CMV and EBV standards Jutta Preiksaitis, PROVLAB, CanadaEBV viral load questionnaire responses Barbara Gärtner, Universitätsklinikum des Saarlandes, GermanyProposals for WHO International Standards for CMV and EBV for NAT-based assays Jacqueline Fryer, NIBSC, UK
General Discussion
SoGAT Clinical Diagnostics I Programme - Day 2
Session 7: Standards for Bacteria and Parasites
Standardisation in meningococcal epidemiology Steve Gray, HPA, UK
Malaria and Toxoplasma standardisation of NAT assays David Padley, NIBSC, UK
Session 8: Control and validation of commercial assays for Clinical Diagnostics
Control and validation of Roche clinical diagnostics John Saldanha, Roche, USA
Performance evaluation of standardized QIAGEN sample preparation methods for the artus CMV PCR Kit Volker Riemenschneider, Qiagen, Germany
Session 9: Regulation of clinical diagnostics
US regulation of IVDs Francisco Martinez-Murillo, FDA-CDRH, USA
CE-marking and regulation of clinical diagnostics in Europe Micha Nübling, PEI, Germany
Presentations available at www.nibsc.ac.uk/partners/SoGAT
SoGAT Clinical Diagnostics I Programme - Day 2
Outcomes
• Highlighted the need for internationally-accepted reference standards to improve the comparability of results
• Proposals developed for new standards for NAT-based assays for clinical targets
– Proposed 1st WHO International Standard for human cytromegalovirus (HCMV)
– Proposed 1st WHO International Standard for Epstein-Barr virus (EBV)
• Proposals subsequently submitted to WHO ECBS and endorsed October 2009
• Future meetings to be held annually, possibly linked with meetings of relevant clinical societies
SoGAT Clinical Diagnostics II
• 30th September and 1st October 2009
• Harbiye Military Museum Istanbul, TURKEY
• To follow directly 12th Annual Meeting of the European Society for Clinical Virology (ESCV)
• Further information
– www.nibsc.ac.uk/partners/SoGAT
Proposed Discussion Topics
• Update on the development of reference reagents for clinical diagnostics (including proposed 1st WHO International Standards for HCMV and EBV)
• Proposals for new references (1st WHO International Standards for JC and BK viruses)
• Assessing assay performance: EQAS and proficiency studies, and data reporting
• Technical aspects of assay variability
• Regulatory and other standardisation issues
Abstract deadline 26 June 2009
Prioritising the development of standards for clinical pathogens
• There is a need for internationally-accepted reference standards for clinical pathogens:
– To improve the performance and comparability of results generated by different assays
– To facilitate the development of uniform treatment strategies
• Need to prioritise the development of these standards on the basis of:
– Clinical need: where there is an intention to treat (BK and JC viruses, adenovirus, HHV-6)
– Where studies indicate variability in assay performance
– Global disease prevalence