Minicare I-20 cTnI usability testing in the ambulance setting at Witte Kruis.

The Minicare I-20 is designed to detect troponin-I levels within 10 minutes.
Performed at the Point Of Care (POC) by paramedics or physicians, it provides
an additional piece of diagnostic information that can positively impact the
efficiency of patient treatment. In particular for patients where no clear
ST-abnormalities show on the ECG but suspicious physiological symptoms are
observed, determining the troponin level on site can be a powerful aid in the
diagnosis of the condition of the patient. It will allow the attending
healthcare professional to assess the best care center (normal hospital or
hospital with PCI center) for the patient

The purpose of the study is to examine how the Minicare I-20 fits into the
ambulance workflow. Relevant process data of the ambulance workflow was
collected (stage 1) looking specifically into chest pain patients. This second
stage will focus on performing cTnI tests in the ambulance workflow using the
Philips Minicare I-20 system. The aim is to:
* Determine how the system can be integrated into the ambulance workflow.
* Measure the usability performance of the system under ambulance conditions
(RH, temperature, sunlight, portability, storage, etc.).

The Usability tests focus on measuring usability performance by performing
capillary (finger stick) sampling in the ambulance flow. Performing tests with
patient samples in the ambulance flow will generate vital data on the
performance and usability of the Minicare I-20 in this use environment.
The test will be performed in or near a (non-moving) ambulance, typically
during the time the ambulance crew is *on scene* performing their routine care
for the suspected ACS patient.

The study objectives are:
* Gather Analyzer performance data
o Performing a Minicare cTnI test in the available time window (between
arriving at the patient and depart).
o Monitor success / failure rate.
* Gather usability performance data
o System usability under ambulance conditions: varying RH and temperature
conditions, and varying lighting conditions
o Cartridge storage: at ambulance station and in the ambulance
o Cartridge disposal
o Analyzer usability: storage in ambulance, portability
o User acceptance
* Part of the usability study is to gather feasibility and usability feedback
on prototypes of dedicated transport cases. The cases provide a means for
cooled storage for the cartridges, possibly charging of the analyzer and
potentially connectivity of the analyzer to the Ambulance IT. The cases also
allow easy and safe transport of the analyzer to the patient.
* Quality assurance in the ambulance setting (performing weekly QC tests)

* The impact on the patient is limited to collecting one finger stick sample.
The total time needed to prepare the system and collect a blood sample is less
than 2 minutes
* Patients will be informed and give consent for inclusion in the study. They
will be offered to reconsider their participation after they have received
initial treatment.
* Patient information will be collected and anonymized before being made
available to investigators other than the medical personnel involved with the
study.
* On occasion ambulance staff will be interviewed by an investigator to analyze
usability acceptance.