The National Institute of Biological Standards and Control (NIBSC) has called upon the scientific community to consider the importance of standardisation in the response to the COVID-19 pandemic.
In a letter published in the journal Nature Biotechnology, the Institute highlights a critical role for standards in harmonising molecular diagnostic tests that have been rapidly developed for SARS-CoV-2. By reducing the variability of results obtained from different laboratories, standards can help to ensure consistency in clinical decisions that affect individual patients such as required isolation times. Additionally, the use of a standard can improve the reproducibility and reliability of data from clinical trials set up to evaluate novel vaccines and therapeutic approaches.
At the NIBSC, work is currently underway, in collaboration with the World Health Organisation (WHO), to develop formal standards to support NAT-based diagnostics for SARS-CoV-2. In the interim, a full-genome reference reagent has been made available (NIBSC catalogue number 19/304) to support the early development of accurate and reliable diagnostic tests. A serological standard and panel is also being produced under the auspices of the WHO.
Further information about this reagent and additional SARS-CoV-2-related reagents available from the NIBSC can be found here.
Moreover, the Medicines and Healthcare products Regulatory Agency, through the British Pharmacopoeia (BP), establishes documentary and chemical reference standards for medicines. To support the response to COVID-19, the BP is offering free access to a portfolio of documentary standards for supportive medicines, available here.