Demonstrating Minicare, a miniaturized biophotonics platform for fast and lab-equivalent
Point-of-Care diagnostics

Heart disease is the largest single cause of death throughout the European
Union. Many patients with heart attacks (myocardial infarction) come to
hospital with chest pain. The two most important tests to determine if this
chest pain is due to a heart attack are the electrocardiogram (ECG) and the
measurement of cardiac troponin in blood.
The Lab 2 Go project is a European Union funded multicentre Research and
Development project (project nr. 621035) involving 5 hospitals in the European
Union, Philips Electronics Nederland B.V. * HandHeld Diagnostics and industrial
partners (Conworx Technology GmbH, MicroSystems (UK) Limited and Scienion AG).
Philips together with its industrial partners has developed a new point of care
analyzer (Minicare), a first test to run on the analyzer (troponin I) and
software that steers the anaylzer and connects the analyzer to the hospital
data bases. In this study the analytical performance and usability od the new
analysis platform in hopsitals is being tested and the system refined where
necessary.

The project determines the value of a novel method of measuring cardiac cTnI at
the patient*s bedside (point of care testing). The study aims to assess the
analytical and clinical performance of a point of care troponin I test using an
novel handheld analyzer (Minicare), compared to available lab based reference
systems.
The scope of the study is to validate and improve the analyzer, the test
cartridge and configuration and the software used. Furthermore work-flow and
performance studies are done to evaluate optimal use of the test system in
triage of chest pain patients.

The Lab2Go project defines 7 work packages of which work package 2 (WP2,
Analytical Performance) and work package 3 (WP3 Usability Performance &
Acceptance) are relevant to this protocol.
In WP2, the analytical charcteristics of the newly developed anlayzer and test
cartridge for measurement of troponin I are established by laboaratory staff.
The study is carried out in two cycles. The analytical performance of the
current versions of the analyzer and test cartridge as well as the software are
assessed in cycle one and modifications are made if necessary. In a second
cycle, the improved performance of the analyzer/cartridge/software are
confirmed.
In WP3, usability performance & acceptance of the newly developed anlayzer,
test cartridge and software in the hand of the intended users are established.
The study is carried uit in two cycles. The usability performance & acceptance
of the current versions of the analyzer and test cartridge are assessed in
cylcle one and modifications are made tot the analyzer, software and/or
cartdige if necessary. In a second cycle, the improved performance is
confirmed.
In both work packages blood samples from patients in the participating
hospitals are used. Part of the plasmas is sent to the central lab (the
Philips' lab on the High Tech Campus in Eindhoven). There troponin I conc. is
measured with a single routine troponin I test system. All materials leaving a
hopsital can not be traced back to an individual patient except by employees of
the collecting hospital who can trace back the sample by linking the study
number to a patient.

The maximal burden for an individual patient may be
-removal of extra blood (max 15 ml onf three ocasions) during a regular
venipuncture and/or
-finger stick (max 3 times)
-answering a few questions before venipuntcture (99th percentil study) or
-answering a few questions on the phone during a 30 day follow up (chest pain
patients).

The risk is almost neglectible and limited to side effects of a venipuncture
(which the patient undergoes anyway).
There is no benefit for a participating patient.