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 Standardsreference 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.

NATSerology
PathogenWHO IS
(Calibration)
Reference Panel
(Validation)
Quality Control ReagentWHO IS
(Calibration)
Reference Panel
(Validation)
Quality Control Reagent
Adenovirus 16/324 - 15/130  - - -
Aspergillius In development - - - - -
BK virus 14/212 - 15/130 - - -
Coronavirus - - 09/132 - - -
Coxsackie B4 - - 08/174 - - -
Cytomegalovirus 09/162 - 15/130 - - 16/B693,
18/B731
Ebola virus 15/222
15/224
- 15/136,
15/138

15/220,
15/262,
16/344

- -
Epstein-Barr virus 09/260 - 15/130 - - -
Hepatitis A virus 15/276 - - - - 13/B634,
17/B725
Hepatitis B virus 10/266
-

14/198,

12/226,
95/522

03/262 07/286
07/288
07/B498
13/B629
14/B651
15/B680
16/B704
17/B717
17/B718
Hepatitis C virus 18/184 14/290 14/198

 14/242
15/B669,
19/240
Hepatitis E virus - - - - - 17/B723,
17/B728
Herpes Simplex virus 1 In development - 15/130 - - 10/B596
Herpes Simplex virus 2 In development - 15/130 - - 13/B642
HIV-1 16/194 12/224,
13/214
99/636
14/198,

90/636 02/210,
16/210
99/750
99/710
11/B608
13/B640
13/B644
15/B671
16/B687
16/B706
17/B720
HIV-2 16/296 - - 16/236 - 99/674
14/B653,
16/B685
HIV (cell-associated) In development - - - - -
Human herpesvirus 6A - - 15/130 - - -
Human herpesvirus 6B 15/266 - 15/130 - - -
Human papilloma virus 

06/202,
06/206,
14/100,
14/104,
14/256,
14/260,
14/262,
14/264,
19/224,
19/226

-

-



- - -
HTLV-1 - - - - In development 03/104
HTLV-II - - - - In development In development
Influenza A virus In development - 07/296,
07/298
- - -
Influenza B virus In development - 07/300 - - -
JC virus 14/114 - 15/130 - - -
Leishmania In development - - - - -
Lyme disease - - - - - 18/B742
Measles - - 13/168 - - 15/B667
Metapneumovirus - - 08/320 - - -
M. tuberculosis In development - - PPDT - -
Mumps virus - - - - - 15/B664
Norovirus GI - - 08/318 - - -
Norovirus GII - - 16/104 - - -
Paraechovirus - - 08/322 - - -
Parainfluenza virus type 1 - - 08/176 - - -
Parainfluenza virus type 2 - - 08/178 - - -
Parainfluenza virus type 3 - - 08/118 - - -
Parainfluenza virus type 4 - - 08/180 - - -
Parvovirus B19 12/208 09/110 15/130

01/602 - 15/B678,
16/B683
Plasmodium falciparum 04/176 - - 16/376 - 13/B627
Plasmodium vivax In development - - - - -
Respiratory syncytial virus In development - 08/120 - - -
Rhinovirus - - 08/324 - - -
Rubella virus - - - RUBI-1-94 -

12/B612,
14/B654,
19/B754

SARS-CoV-2 In development - 20/110 In development In development 20/B764
Toxoplasma gondii 10/242 - - 01/600,
13/132
- 16/B695,
17/B710
Treponema pallidum - - - - - 15/B673,
17/B713
Trypanosoma cruzi I In development - - 09/188 11/216 -
Trypanosoma cruzi II - - - 09/186 - -
Varicella Zoster virus In development - 15/130 - - 14/B655
West Nile virus (WNV) In development - - - - -
Zika virus - - 16/110
16/352  - 16/320