H232: Analytical Validation of the Roche Cardiac Reader

D-dimer, troponin T and NT-proBNP are three laboratory tests that are
frequently ordered in emergency situations (suspected thrombosis / pulmonary
embolism, myocardial infarction, heart failure). The standard procedure in
which tubes are sent to the laboratory for measurements are time-consuming, and
might slow down decision making. The Roche cardiac reader H232 is a
point-of-care device, which has the advantage that these parameters can be
measured at the bedside of the patient. This saves time and can thus save
health costs.

Primary Objective: To assess the analytical performance of the cardiac reader
Secondary Objective(s): To assess the user friendliness of the device
(handling, analytical speed).

We will assess the analytical performance of the roche cardiac reader. This
includes 3 analytes: D-dimer, NT-pro-BNP and Troponin T. For each analyte we
will need 50 samples in order to make a proper method comparison.
Blood for measurement of these analytes in our daily routine (roche cobas
platform) is drawn in lithium heparine tubes (Greiner) with gel. Blood for
measurement on the H232 cardiac reader has to be drawn in a hepine tube without
get. Therefore, we have to collect an additional tube for validation purposes.
The study is designed as follows:

- Each patient for whom one of the analytes of interest is ordered (d-dimer,
NT-pro-BNP, troponin T) will be asked to donate extra blood:
o 1 lithium heparine tube (without gel) in case of NT-pro BNP or
Troponin T
o 1 lithium heparine tube (without gel) and 1 sodium citrate tube in
case of d-dimer.
- The material will be send to the lab, the standard tube (with gel) will be
processed as usual (measurement of analyte on the Roche Cobas).
The materials will be centrifuged first to generate plasma.
- The lithium heparine tube without gel will be used for measurement on the
H232 cardiac reader. For this measurement, 150ul of
uncentrifuged blood is needed
- The sodium citrate tube (only in case of a d-dimer measurement) will be
centrifuged to generate plasma. The plasma will be kept
refrigerated until measurement on the Innovance platform.
- The patient details will be anonimised, only a lab number and a result for
both methods will be recorded.
- For each analyte, a sample with a high and low test result, generated with
the reference method, will be selected and measured 5 times in
a row on the H232 (reproducibility measurement).
- The generated results will be analysed statistically.

Drawing additional blood sample from existing vena puncture

There is a need for point of care testing, since it offers shorter turn around
times and therefore faster decision making. With this study we hope to improve
patient management in the near future. These benefits outweight the very small
risks that are concerned with the small volume of extra blood collection for
the individual patients.