The National Institute for Biological Standards and Control (NIBSC) has formulated a series of controls to assist diagnostic laboratories throughout the forthcoming winter respiratory virus season.
The NHS Winter multiplex (NIBSC code 20/170) is a CE-marked reagent that serves as a positive control for the validation and standardisation of Nucleic Acid Amplification Testing (NAT) assays. It can be used with assays for the detection of the following viruses:
The SARS-CoV-2 component of this control has been inactivated and therefore this product should be categorised as an ACDP Hazard Group 2 pathogen.
The NIBSC has also produced a range of calibrants that can be used to support the assessment of assay sensitivity in the absence of a WHO International Standard being available.
For each target pathogen, a panel of seven samples is provided. This includes six serial dilutions which enable laboratories to identify the lower limit of detection of their assay system. There is also a negative control for monitoring cross contamination.
Each panel is intended to be tested as an entire panel and should be used with a suitable assay designed to detect the target pathogen. The panels are not designed for assay specificity studies.
Individual controls for the following winter viruses are also available as part of the Clinical Virology Network regent portfolio:
If you require further information about any of these reagents, please contact diagnostics@nibsc.org.