It was for this reason that the UK Clinical Virology Network told NIBSC in the mid-2000s that standardising clinical results was essential to make progress in patient care.
We knew early in this project that these reagents would have to be made under the In Vitro Diagnostic (IVD) Medical Devices Directive (98/79/EC) of the European Parliament. It became mandatory to comply with the IVD Directive in December 2003, and since then all in vitrodiagnostic medical devices (IVDs) on the market must carry the CE mark.
NIBSC provides over 25 CE-marked run control reagents to ensure the fidelity and reproducibility of molecular assays.
As polymerase chain reaction (PCR) diagnostics rapidly evolve, multiplexed reagents are now the preferred choice of diagnostic laboratories. Because of this, NIBSC has made significant progress towards providing these controls in a multiplexed freeze-dried formulation.
Although we currently provide controls directed toward viral pathogens, we are actively engaged in providing controls for both bacterial and parasitological pathogens.
After years in the Public Health England (PHE) site at Colindale in North London, the QCRU relocated to NIBSC in 2010. The unit currently provides a portfolio of 34 CE-marked control sera that are used by key clinical specialists both in PHE and the NHS in the UK, together with many international customers.
Alongside the molecular standards the group provides, we also provide an extensive panel of serological reagents prepared by the QCRU. Currently the unit has a portfolio of products which fall under the remit of the IVD directive and which are prepared to ISO13485. The group is annually audited by the Underwriters Laboratory (UL) for compliance against the standard.
As with molecular standards, reagent development in QCRU is very important. We have introduced two new reagents to help standardise serological assays to detect responses to infection by rubella and Varicella Zoster Virus – the disease-causing agent of chicken pox – (VZV).
We always aim to plan the production and development of new reagents in the medium and longer terms, in response to the changing needs of our customers. We are currently planning to introduce serological reagents to help standardise assays used to detect various parasitic infections.
All molecular and serological reagents prepared by NIBSC are accredited to ISO13485 and we are annually audited by UL for compliance against the standard.
The group currently carries out research as part of its general duties. This includes practical areas of study such as investigating new formulations for freeze-drying and investigating increasing the shelf-life of products without affecting potency.
We constantly seek newer, more sensitive and more accurate assays for plasma pool testing. We keep a watching brief on all areas of technological development to implement state-of-the-art techniques as needed. Our group is at the forefront of the new digital PCR technology.
Because we have a massive sample archive at NIBSC stretching back nearly 25 years, we are well-placed to look at the rise of new disease-causing agents such as Hepatitis E virus.
Dr Rob Anderson, Principal ScientistMr David Padley, Senior ScientistMr Josh Duran, ScientistSara Fabi, Scientist
QCRU reagent list
08/114: Adenovirus (type 2)09/132: Coronavirus(229E)08/174: Coxsackievirus B (type 4, strain J.V.B. Benschoten)(229E)08/316: Epstein-Barr virus (B95-8)(229E)08/224: Herpes simplex virus type 1 (strain 17)08/226: Herpes simplex virus type 2 (strain HG52)08/314: Human cytomegalovirus (AD169)08/320: Human metapneumovirus (type A)08/324: Human rhinovirus 39 (group A)07/296: Influenza A H1N1 (A/Christchurch/1/2003)07/298: Influenza A H3N2 (A/Wyoming/3/2003)07/300: Influenza B (B/Jiangsu/10/2003)08/318: Norovirus (genogroup I)07/294: Norovirus (genogroup II) 08/176:Parainfluenza virus type 108/178: Parainfluenza virus type 208/118: Parainfluenza virus type 308/180: Parainfluenza virus type 408/322: Parechovirus (type 3)08/120: Respiratory syncytial virus (type A2)08/310: Varicella Zoster virus (type B)13/168: Measles (MVi/Moscow.RUS/0.88)
Blood borne Pathogens:13/102: HAV RNA working reagent11/182: HBV DNA working reagent02/264: HCV RNA working reagent11/208: Parvovirus B19 DNA working reagent
Non CE marked reagents for Research Use ONLY:12/172: Hepatitis C genotype panel99/732: Multiplex (HAV, HBV, HCV, HIV, Parvovirus B19)