Med-Tech Innovation News spoke to Kathleen Orland, senior vice president and general manager for Beckman Coulter’s clinical chemistry immunoassay about the key role of Access hsTnI assay to detect at-risk patients earlier and discharge non-acute patients faster.
How was the test developed? Please give as much insight about the technology behind it as possible.
Beckman Coulter’s Access hsTnI assay provides much greater precision when measuring at very low levels vs. previous troponin assays. This is made possible by a generational evolution in the technology used. The new assay was developed from the ground-up; every key design element has been updated including both antibodies utilised in the assay as well as paramagnetic particle and signal chemistry used for capture and detection of the troponin protein.
What allows the test to offer high-sensitivity performance?
High-sensitivity performance is characterised by a test’s detection capability at the low end of the measuring range. A true high-sensitivity must measure with imprecision of <10% CV at the medical decision point, and be able to detect troponin in a majority of healthy men and women. The Access hsTnI assay employs a new pair of monoclonal antibodies that bind different epitopes on the troponin molecule vs. Beckman Coulter’s previous assay design. This has made precise detection of very low levels of troponin possible. In addition, the new paramagnetic particle used in the design has a smoother more uniform surface, which reduces susceptibility to interferences caused by non-specific binding.
How quickly are test results turned around?
The test has a ‘time to first result’ of 17 minutes. This is the time between presentation of the sample to the analyser and when the result is returned. From a clinical standpoint, peer-reviewed research and recent updates to European Society of Cardiology Guidelines support using Access hsTnI in one and two-hour rapid diagnostic algorithms, which help physicians to either rule in or rule out myocardial infarction earlier in the course of care.
Is this kind of test used to diagnose other conditions? Is there room for diversification?
There is ongoing research in a diversity of areas that show potential to expand the clinical utility of high-sensitivity troponin assays in the future. For instance, hsTnI assays have a demonstrated ability to risk-stratify patients with stable cardiovascular disease and identify those at higher risk for future adverse events. More research, and ultimately interventional clinical trials will be needed to determine the true benefit of using hsTnI in expanded indications, but there is certainly a lot of untapped potential.
How can the test be developed further?
There will always be opportunities for improvement as technology evolves. These improvements might lead to even faster turn-around of results that support critical care in Emergency Department settings.
