New diagnostic technology set to play an important part in improving the quality of testing for influenza in order to meet new US Food and Drug Administration (FDA) criteria.
Flu virus
After one of the worst flu seasons on record to affect the US, the FDA issued new guidelines for the accurate diagnosis of influenza to enable earlier treatment. These guidelines have been put in place to improve the overall quality of testing for influenza and has reclassified rapid antigen influenza tests from Class I to Class II.
As per these new agency standards, false negatives can be given by rapid antigen tests in no more than 20% of tests. Prior to this, there were no established performance criteria for these kinds of tests.
For manufacturers of influenza tests these new guidelines can have a significant impact as they are now required to re-optimise their tests to be able to identify the presence of influenza in potential sufferers.
In response to these challenges, BBI Solutions is working with manufacturers using its Morffisignal enhancement technology. This tech helps to boost the sensitivity of rapid lateral flow influenza tests, helping to ensure that suspected flu sufferers can be rapidly and accurately identified.
“Each year in the United States, seasonal influenza leads to between 140,000 and 710,000 hospitalisations and as many as 56,000 deaths. This is a devastating disease that has been a constant threat for hundreds of years,” explained Morgan West, new product development lead at BBI Solutions and one of the inventors of the Morffi technology. “Developing diagnostics that provide an accurate, rapid diagnosis of the virus is the first and most crucial step to tackling this global threat. Exploring and adopting new technology and approaches offers us the best possible chance of tackling influenza.
“The significant changes to the regulations around rapid influenza tests, mean many manufacturers now need to take urgent steps to improve the quality and sensitivity of their influenza assays to ensure they can detect trace amounts of the virus, keep communities safe and meet the FDA’s new criteria.
“What many manufacturers have found is that although their assays may look good on paper, when they’re being used in the field they’re experiencing a high number of false negatives, which is putting people at risk and means their tests lack the sensitivity needed to meet the FDA’s new standards.
“BBI Solutions’ break-through Morffi technology has the potential to boost the sensitivity of rapid lateral flow diagnostics tests – providing a great tool that will help companies to upgrade their existing lateral flow tests and create future-fit diagnostics which are optimised to combat this global threat and meet the new legal requirements set out by the FDA for these tests.”
Commonly, lateral flow immunoassays — which rely on specific interactions between the analyte of interest and an immobilised binding partner — use BSA as a conjugate blocker. These, however, can cross-react with human serum albumin-binding antibodies, bovine and other animal-origin targets and exhibits lot-to-lot variability.
Additionally, BSA is relatively large in size, which can lead to steric hindrance, reducing binding of the analyte to the antibody and hence affecting the performance of the assay. Morffi technology uses novel synthetic blocking agents that are smaller in size to overcome these issues and is believed to allow increased opportunity for successful interaction between the antibody on the detector label and the target analyte, resulting in enhancement of signal at test line.
The company has deployed its technology against multiple different targets using monoclonal and polyclonal antibodies and using both sandwich and competitive assay formats.