Diagnostics
The Division of Infectious Disease Diagnostics (IDD) was formed in December 2018. It encompasses the Institute’s activities in the development and application of reference materials that underpin the specific and sensitive detection of infectious diseases by molecular and serological techniques.
Standards and reference materials
We prepare International Standards used as higher order standards to calibrate assays as well as external run controls used to assure the day to day performance of diagnostic assays for a number of viral, bacterial and parasitic infections of human importance.
Plasma pool testing
Building on our standardisation expertise, we undertake the independent testing of plasma pools used in the preparation of blood products, to assure their freedom from contamination with blood-borne viruses such as Hepatitis B, Hepatitis C and HIV.
CJD Research and Resource Centre
Our scientists curate extremely valuable materials that may be used to establish the suitability of assays to detect “infectious” variant Creutzfeldt Jacob Disease (vCJD) in blood or other biological materials. We are now broadening our interests and investigating how to standardise measurement in novel highly sensitive methods for the detection of other neurodegenerative diseases such as Parkinson’s and Alzheimer’s.
Centre for AIDS Reagents
IDD holds the Centre for AIDS Reagents (CFAR) which has been supplying cells, proteins, antibodies, viruses and other research reagents to AIDS scientists for over 30 years. The Centre is diversifying its interests and is collecting and distributing similar research reagents for other emerging diseases such as SARS-CoV-2.
Genomics Group
The MHRA Genomics Group leads the development of novel reference materials to support the harmonisation of performance and measurement of molecular diagnostic tests for oncology and genetic disorders.
We have a growing portfolio of Reference materials and most recently, we have developed the first set of WHO International Reference Reagents Epidermal growth factor receptor variants, the WHO 1st International Standards for Cancer Genomes, the WHO 1st International Reference Panel for genomic KRAS codons 12 and 13 mutations and the WHO 1st International Reference Panel for Genomic JAK2 V617F variant.
We have a strong interest in bioinformatics tools and pipeline for the analysis of genomic data as well as applications of multi-omics in oncology diagnostics.
We have several ongoing research projects in the field of regulatory science and capability for large scale production of cell lines.
Please contact us if you would like to collaborate with us or just hear more about our work.
Microbiome Group
The MHRA Microbiome Groups leads the development DNA and Whole-Cell Standards for analysis of the Gut, Respiratory, Skin, Oral Cavity and Vaginal microbiomes. To date, we have developed the 1st WHO International Reference Reagents for Gut Microbiome analysis by NGS and the 1st WHO International Reference Reagent for DNA extraction of the Gut Microbiome. All developed Reference Reagents are required to undergo an international collaborative study which can require as many as 20 international partners to validate reagents. This work is now expanded to fungi, AMR and phage.
Besides our Standardisation Programme, we are also interested rapid diagnostics for bacterial and fungal infections, limits of detection, as well as understanding how microbes interact with one another and the human host. We have a large anaerobic cultivation facility and strain collection, developing several model systems and we work closely with MHRA Next Generation Sequencing and bioinformatics colleagues to perform high-throughput sequencing experiments and data analysis; please contact us if you have any questions about our work, would like to collaborate with us, or would like to join one of our large international collaborative studies.
More information about our projects and team members can be found here: NIBSC - Microbiome.
Other research activities
Research activities in IDD include establishing whether diagnostic standards for emerging diseases may also be valuable as reference reagents to support the development of vaccines against diseases such as Ebola, Zika and Chikungunya. This research team also maintains interest in understanding the responses needed by effective vaccines against HIV/AIDS.