The application of CMD technology for the rapid, in-field diagnosis of malaria demonstrated unequivocally the potential of the proprietary magneto-optical platform as a diagnostic system.
All five species of malarial parasite express broadly similar behaviour, but Plasmodium falciparum causes the most severe clinical form of malaria in humans. The parasite lifecycle is complex and it is only when it resides in red blood cells that it is symptomatic and detectable by diagnostic tests. Its impact in this phase arises from its destruction of the oxygen carrying haemoglobin. It metabolises the globin part of the molecule and in the process converts the toxic haem component to haemozoin a harmless metabolic product.
Under laboratory conditions CMD technology can easily detect nanorods of haemozoin at concentrations of the order of 1ng/ml, when their dimensions are typical of the haemozoin crystals produced by mature parasites in the later stages of the blood phase infection.
CMD understands the factors affecting the relationship between the parasites lifecycle, the size of the haemozoin nanorods produced at each point in the lifecycle and the sensitivity with which these rods can be detected magneto-optically.
The diagnostic device developed in the malaria application has the advantage of being small, robust, and deliverable at low capital cost, as well as rapid and low cost in use.
Sepsis is “a life threatening condition that arises when the body’s response to an infection injures its own tissues and organs”. Striking with equal ferocity in both the developed and developing worlds, an estimated 20 to 30 million people are affected by sepsis each year. With mortality rates of up to 70% the disease kills one person every few seconds, accounting for approximately one third of all deaths worldwide. In addition to the enormous human cost, sepsis also imposes a massive burden on global healthcare resources.
Sepsis is a complex, rapidly evolving condition. Unfortunately, clinical symptoms such as raised temperature, increased heart and respiratory rate, or current laboratory diagnostics, such as white blood cell count or bacterial culture are relatively non-specific, time-consuming and critically lack the requisite sensitivity needed to provide a definitive early diagnosis. Delay in diagnosis impacts hugely on clinical outcome with the risk of death increasing by 6-10% for every hour delay in delivering appropriate therapy. The ability to diagnose sepsis early and subsequently monitor disease progression in real-time would revolutionise the clinical management of sepsis.
CMD are supported under the Innovate UK Medical Technologies Launchpad Wales programme to develop a multiplex diagnostic assay that can be used at the point-of-care for the rapid diagnosis of sepsis. The assay panel will include pathogen and host related markers of lipid, protein and genetic origin.
Over the last 20 years, there has been a paradigm shift in the field of veterinary diagnostics with a growing reliance on technologies to more rapidly and definitely monitor animal health.
The increased number of animal disease outbreaks, and the accompanying difficulty of monitoring wild animals to prevent widespread transmission, coupled with an increase in companion and food-producing animals means that field of veterinary diagnostics has high-growth potential. Veterinary diagnostic applications to which the CMD single and multi-analyte platform would be well suited include the detection of viral and bacterial pathogens, point-of-care endocrine function assays and parasite detection. Given the malaria provenance of the technology, obvious and important applications exist in the detection of protozoan zoonoses such as Giardia, Toxoplasmosis and Leishmaniasis and Lyme Disease – the prominent zoonotic tick borne disease caused by the bacteria Borrelia burgdorferi.
The increase in demand for biological safety testing has been driven by population growth and the accompanying rise in disease burden, producing an increased demand for parenteral pharmaceutical products. All medicinal products intended for parenteral administration are screened for endotoxin as part of the quality control process, as even picogram levels can induce a sepsis-like syndrome. Current gold-standard endotoxin assays rely on the use of animal derived materials and are prone to interference from sample matrix components.
CMD has already demonstrated an ability to detect endotoxin, providing the early possibility of a single analyte system and – as we move towards a multiplex end-point – the capability to detect a range of other ‘pyrogenic’ toxins.
The quality of the 22,000 registered bathing beaches Europe is governed by the European Bathing Water Directive, which sets legislation and defines the standards all beaches must comply with in order to be considered as a designated bathing beach. Faecal Indicator Bacteria (FIB) – namely Escherichia coli and enterococci – are important indicators for determining the quality of marine bathing waters, as they can eliminate the need for expensive and time consuming testing for pathogenic bacteria and viruses. The current use of quantitative culture-based FIB testing methods take at least 24 to 48 hours to produce a test result, meaning the results are always retrospective. Just as in the case of biopharmaceutics testing, the CMD platform could bring major advancements to the rapid screening of both marine and fresh water for faecal, toxic algae and chemical contamination.