Standards and reference materials for infectious disease diagnostics

The importance of reference materials in infectious disease diagnostics

Infectious disease can be diagnosed using serological methods that detect the presence of antigens or antibodies produced as a result of infection. Alternatively, they can be diagnosed by measurement of pathogen DNA or RNA using nucleic acid amplification techniques (NAT).

The use of reference materials is vital to ensure that measurements performed on patient samples using these methods are comparable over time and between different laboratories.

NIBSC established the International Working Group on the Standardisation of Genomic Amplification Techniques (SoGAT) in 1995 to help harmonise NAT-based tests.    

Under the guidance of this working group, we have developed a wide range of reference materials for infectious disease diagnostics. Our full product list can be found in the table below. 

Choosing the correct reference material

We offer several different types of reference material, each with a specific intended use.

WHO reference materials:

We produce World Health Organisation (WHO) International Standards, reference reagents and panels for the calibration or validation of infectious disease tests. WHO International Standards are recognised as the highest order primary references and are intended for the calibration of secondary references according to WHO guidelines.

Quality control reagents:

We also produce quality control (QC) reagents for NAT and serological diagnostic tests for a wide range of infectious diseases. These are intended to monitor the performance of a test over time and are calibrated against WHO International Standards wherever possible.

Production of all our QC reagents is accredited to ISO 13485. Many of our QC reagents are CE-marked to comply with the European In-vitro Diagnostics Directive (IVDD).

NIBSC NAT and serology QC reagents can be used in conjunction with NIBSCs online Results Reporting System (RRS) to better enable diagnostic laboratories to comply with ISO 15189. RRS is a secure web-based application allowing real-time data processing, graphical output and anonymised worldwide peer comparisons.

Reference materials for NAT and serology

Click on the product code for more information and ordering. Printable information leaflets about our infectious disease diagnostics reference materials and services are also available. For technical enquiries please contact diagnostics@nibsc.org.