Optimising an Existing Assay – From Blood to Patient

Feasibility Studies in Medical Diagnostics

Feasibility studies are usually preliminary analyses to determine the viability and practicality of a proposed project or new business venture. In terms of medical diagnostics, it’s pretty straightforward – Does it work? Is the diagnosis clear? Can it be productised? Is it practical to use a particular medical device in a near-patient environment?

However, we recently undertook a slightly different type of feasibility study for a pre-existing assay, used to diagnose infection – to answer the question, ‘can a diagnosis be achieved faster?’

Can an assay be improved or optimised?

With all medical diagnostics, time is of the essence. Faster diagnosis means that any relevant treatment can be given sooner which could mean the difference between life or death for an individual.

So to improve or optimise an existing assay would mean to make significant alterations for a better diagnostic product.

Sepsis or Infection Diagnosis

Traditionally, after a patient exhibits symptoms of infection, a clinician will request microbial culture to examine, with results taking anywhere between 1-3 days. During which time an empirical prescription (without a precision diagnostic result) is given to the patient, in the form of antibiotics. These empirical prescriptions can often be inappropriate, leading to antibiotic overuse (where it wasn’t necessary in the first place). If a diagnosis can be made sooner – in a matter of hours rather than days – these prescriptions would be reduced or deemed unnecessary.

A Diagnostic to Rule Out Infection

In this particular study, our team was testing for the presence or absence of an infection in blood samples, with the aim of further reducing the time it takes to get a clear result.

By optimising the sample prep and qPCR thermocycling conditions, a diagnostic task that usually takes up to 6 hours can now be done in under 2.5 hours.

Why is this important?

This research was done using equipment that is readily available to the NHS. By cutting down the waiting time, these blood test results can be achieved faster, which means any relevant treatment can be given to the patient sooner, and antibiotic overuse can be avoided.

We’re incredibly proud of Fran Heald & Eleanor Edwards-Jones for the exceptional effort that these two have put into this feasibility study, leading to a glowing reference from a customer. Medtechtomaket isn’t just bringing medical diagnostics to market, we’re making sure that every study, trial, test, and product is best-in-class.