For example, it is anticipated that diagnostic tests will play an important role in stratifying patients into different disease sub-groups to enable more targeted (and cost-effective) treatment. Also, the drive to reduce the length of hospital stays will mean more people with chronic conditions will be cared for at home with remote monitoring technologies helping physicians to track the patient’s condition.
New challenges on accuracy and precision
Many of the new diagnostic technologies will be used in the relatively uncontrolled environments – compared to traditional clinical laboratories – of the patient’s home or the doctor’s office. In addition to the challenge provided by the environment, the range and type of samples and the variable skill levels of the user will all provide challenges to the reliability of the test and the accuracy and precision it can deliver.
Of course, the regulatory process ensures that only diagnostic tests with acceptable levels of sensitivity, specificity, accuracy and precision are approved for use. However, a recent report on blood glucose monitoring (BGM) systems - the most widespread and well established self-test diagnostic - suggests that while this might be true for diagnostic tests carried out under laboratory, or simulated user, environments, in the hands of real users and conditions, diagnostic test results can be inaccurate.
So whilst innovative manufacturers of modern BGM systems have made enormous strides in improving the convenience of use (reduced blood volume requirement, shorter time to result, smaller meters, integrated meters housing test strips etc.), equivalent progress on accuracy and precision in real-world diagnostic performance has not been as evident.
A new approach to improving diagnostic accuracy and precision
Looking forward, the question is how can manufacturers of existing and new self-test and point-of-care diagnostic tests improve real-life diagnostic accuracy and precision?
One approach, for which PA has been granted a patent, is where a small, known quantity of the target analyte is added to the test sample on the disposable part of the system to quantify the sample matrix effects. This approach has broad applicability and should enable correction for a number of potential sources of inaccuracy.
In our view, balancing enhancements in diagnostic performance with continued focus on user convenience will encourage market growth and will help realise the full potential of diagnostics in the reshaped healthcare environment.
If you would like to know more about PA’s patented approach to improving diagnostic accuracy and precision, please contact us