Implementing point of care high-sensitivity cardiac troponin testing in the emergency department

My name is Damien Gruson. I am a professor and head of the department of clinical biochemistry in an academic hospital in Brussels, Cliniques Universitaires Saint Luc.

We need rapid and accurate cardiac troponin assay because there is an important clinical niche that the clinicians, the emergency department need for the diagnosis of myocardial infarction.

They rely on the results to make the accurate diagnosis, and as fast we can be as much we can preserve muscle and cardiac muscle. So we have this challenge and that's why we need this kind of assay.

So the key benefits of performing point-of-care fingerstick assay for troponin testing in the ED are at least at two levels. The first one is the physician having fast results on-site in the acute care facilities. I see also the benefits for the patient and the physician, the sampling will be less invalid.

You will need to collect less blood. There is prerequisite before moving forward which is confirm the performances, analytical performances, having an assay meeting the standards, low limit of quantification, confirm the clinical performances.

And I will add also evaluation of the practicabilities, so how it will fit with the user experience, nurses, doctors less familiar with laboratory tests. So how do it compares with the central lab, that's currently the need for game-changer because most of the point-of-care assay for troponin testing are less sensitive than the central lab test.

So the limit of quantification are higher than in the central lab. So we need new assay, more sensitive. So the ability of IVD manufacturers to develop high sensitive or ultrasensitive troponin assay by point of care, that's a challenge.

That's not an easy task. But I think it in the hands of the physician will be, I think, a real game-changer for the diagnosis of myocardial infarction. The key consideration when you need to transition to point of care, of course, as I already mentioned in the performances.

Ensure that we have the same performances that the central lab, analytical and clinical. Ensure that you are giving the efficient and minimum training to the staff that will use the point of care even if it's in the emergency department or in the primary care settings.

So the laboratory will play an important role in the training and the continuous education of the staff. Ensure that you are establishing a quality control policy that will be important to keep the monitoring of the performances of the instrument.

Ensure that you have the connectivity because it's really important to be able to transfer the results to the records of the patient and connectivity is already ensuring the hospital setting, it's more a challenge when you're outside of the hospital in the case of primary care, but connectivity and informatic infrastructure is really important.

You will need to assess also the legal context and the legal framework around your point of care and then the cost-benefits analysis. So in comparison, again, to the central lab assay, you will have the advantage of rapidity, less invasiveness, but what is the cost impact?

Important. And maybe additional point will be the analysis of outcome. So how will the point of care will impact the clinical outcome in comparison to central lab pathways when you need to compare both pathway in parallel also for this point.

As summary, I will say I think ultrasensitive point-of-care assay for troponin testing will offer the opportunity to physician to rapidly and accurately diagnose myocardial infarction, will change also and will impact the operation and the triage in the clinical care settings.

We are also aligned with the guidelines from scientific society with the triage that should be performed within the hour. And we have less invasive sampling for the patient, so we are matching important criteria in term of clinical benefits, patient safety, reliability, and I will say experience at large.