With the USA in recovery from one of the worst flu seasons on record, scientists at BBI Solutions have highlighted the role that new technology can play in re-optimising the current generation of flu tests and ensuring communities are protected in peak flu season.
100 years on from the 1918 pandemic during which 50 million people died from influenza – the virus is still a significant threat. Influenza infection rates in the USA this year hit eight per cent, with record numbers of Americans hospitalised with Aussie Flu in February. Over 50 states were affected by the epidemic with hundreds of thousands hospitalised.
Accurate diagnosis is key in identifying and rapidly treating influenza, and, in many cases, existing tests werent able to detect the virus, leaving communities at severe risk and contributing to the wider problem.
To combat this, the FDA has issued new guidelines to improve the overall quality of testing for influenza and has reclassified rapid antigen influenza tests from Class I to Class II. The agency's new standard for rapid antigen tests is that they can give false negatives in no more than 20 per cent of tests; previously there weren't established performance criteria for the tests.
This has significant implications for manufacturers of influenza tests – who now need to take urgent steps to ensure their tests are re-optimised to identify the presence of influenza in potential sufferers. For manufacturers, this can be a particular challenge with existing test products that dont meet the FDAs criteria.
BBI Solutions is utilising its novel patent-pending MorffiTM signal enhancement technology, to work with manufacturers to boost the sensitivity of their rapid lateral flow influenza tests to help ensure that suspected flu sufferers can be rapidly and accurately identified.
The new technology, which launched in 2017, boosts test sensitivity and provides an up to ten-fold improvement in the limit of detection, it can also offer a faster time-to-result for situations where a quick diagnosis is critical to patient care. Lateral flow tests can therefore be a vital weapon in the in the battle to diagnose and combat the spread of influenza pandemics.
Morgan West, New Product Development Lead at BBI Solutions and one of the inventors of the Morffi technology said: “Each year in the United States, seasonal influenza leads to between 140,000 and 710,000 hospitalizations and as many as 56,000 deaths. This is a devastating disease that has been a constant threat for hundreds of years.
“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 FDAs new criteria.
“What many manufacturers have found is that although their assays may look good on paper, when theyre being used in the field theyre experiencing a high number of false negatives, which is putting people at risk and means their tests lack the sensitivity needed to meet the FDAs 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.”
Lateral flow immunoassays (LFIs) rely on specific interaction between the analyte of interest and an immobilised binding partner, such as an antibody. Typically, a second antibody is then bound or conjugated to a detector label such gold colloid and when the analyte of interest binds to both antibodies a coloured line is developed on the test to indicate a positive result. To improve the performance and stability of the detector particle conjugates, a blocking agent is bound to unoccupied sites on the detector label, preventing non-specific binding.
However, the most commonly used conjugate blocker, BSA, can cross-react with human serum albumin-binding antibodies, bovine and other animal-origin targets, and exhibits lot-to-lot variability. Its relatively large size can also potentially lead to steric hindrance, reducing binding of the analyte to the antibody and hence affecting the performance of the assay.
The proprietary Morffi technology overcomes these issues. Morffi technology utilises novel synthetic blocking agents that are significantly smaller in size than BSA. The size difference 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 the test line. The increased availability of the antibody can also result in up to four times faster time to test result.
BBI Solutions has now deployed the Morffi technology against multiple different targets using monoclonal and polyclonal antibodies and utilising both sandwich and competitive assay formats. Evaluations have taken place across the majority of diagnostic sectors where speed and improved sensitivity are crucial, showing some impressive results.
For more information about BBI Solutions or the Morffi technology, please visit: