Primary objective of the study is to compare the readings of the different sample types (venous whole blood, plasma and capillary) for the three different analytes (BNP / NT-proBNP / D-dimer) on the Atellica VTLi system, according to CLSI EP09c…
ID
Source
Brief title
Condition
- Heart failures
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome consists of the regression parameters (including slope and
associated 95% confidence interval) of a regression analysis of the measurement
results of the Atellica VTLi System. The regression used for this will be the
Passing-Bablok method or other regression method recommended by CLSI EP09c. The
regression parameters will be calculated for the combinations of sample types,
as follows:
• Venous whole blood / capillary
• Venous whole blood / venous plasma
• Capillary / Venous Plasma
This analysis will be performed for all three analytes (BNP, NT-proBNP and
D-dimer), thus resulting in 9 regressions. The correlation coefficient will
also be determined for each of the 9 data sets.
In addition, the bias in Bland-Altman plots of samples above the limit of
quantification (LoQ) will be determined for the different pairs of samples.
Secondary outcome
The secondary outcome is a graph and bias determination of the differences
between venous whole blood and plasma measurements, using a Bland-Altman
analysis. Hematocrit (x-axis) will be plotted against the percent difference
between whole blood and plasma results (y-axis). Analysis by regression will
determine the possible bias and maximum hematocrit value.
Analysis of data from the method comparison study will consist of the above
regression parameters based on Passing-Bablok analysis and an associated
correlation coefficient for each analyte, comparing the measurement results on
reference equipment (x-axis) with the measurement results on the Atellica VTLi
System (y-axis).
Background summary
The Atellica VTLi BNP/NT-proBNP/D-Dimer Test System is a portable test system
for in vitro diagnostic use in the quantitative measurement of B-type
natriuretic peptide (BNP), N-Terminal pro B-type natriuretic peptide (NT-proBNP
) and/or D-dimer in fresh human capillary (fingerstick) whole blood, venous
whole blood or plasma using the Atellica VTLi Immunoassay Analyzer. This test
system is intended for point of care (POC) and central laboratory use and
consists of a dedicated reagent test cartridge, analyzer and associated docking
station and service software. The BNP and NT-proBNP tests can be used as an aid
in the diagnosis of heart failure and as an aid in assessing the severity of
heart failure (HF). The D-dimer test can be used as an aid in the diagnosis of
deep vein thrombosis and pulmonary embolism.
For the development of this new method, it is necessary to establish that the
results in different sample types (venous whole blood, plasma and capillary)
are equivalent. This information is currently not available as the system has
just been developed, and is now being validated and verified. Promising results
have been found from previous (pre)clinical studies with a different test
configuration, with good correlations between the different sample types for
the 3 analytes.
Study objective
Primary objective of the study is to compare the readings of the different
sample types (venous whole blood, plasma and capillary) for the three different
analytes (BNP / NT-proBNP / D-dimer) on the Atellica VTLi system, according to
CLSI EP09c guidelines.
Secondary Objective is to analyze blood-plasma differences as a function of
hematocrit (Hct) values.
Frozen plasma samples will also be used for a method comparison study with
reference equipment; hereby the measurement results of the Atellica VTLi test
system in plasma will be compared with measurement results on reference
equipment for the three analytes, according to CLSI-EP09c guidelines.
Study design
In this study, the concentrations of BNP, NT-proBNP and D-dimer are measured in
capillary, venous whole blood and plasma samples with the Atellica VTLi test
system. Patients who meet the inclusion and exclusion criteria will be
approached for participation. There is no intervention other than taking a
finger prick and extra blood tubes.
The BNP and NT-proBNP venous whole blood and plasma tests will be performed
with blood from an EDTA collection tube, the D-dimer venous whole blood and
plasma tests will be performed with blood from the citrate collection tube.
Study burden and risks
The patient undergoes a finger prick, during which it is possible that a slight
pain in the finger is experienced for a very short time (about 1 minute). In
addition, with a venous blood sample (which usually takes place routinely), two
tubes of blood (<4 mL) are taken. Therefore, the burden of participation is
very low and the risk involved in participating in the study is negligible. On
the other hand, exactly this patient population would benefit from accurate and
rapid diagnostics for BNP, NT-proBNP and D-dimer at the point of care, i.e. the
product that can be developed through these study.
High Tech Campus 29 room P.628.A
Eindhoven 5656 AE
NL
High Tech Campus 29 room P.628.A
Eindhoven 5656 AE
NL
Listed location countries
Age
Inclusion criteria
Age>/= 22 year; and
Patients with suspected or diagnosed heart failure, deep vein thrombosis and/or
pulmonary embolism; and
Competent patients who have given consent and signed for participation.
Exclusion criteria
Age< 22 year; or
Patients with cognitive impairment or inability to understand study
information; or
Patients who are unwilling or unable to give written consent; or
Patients previously enrolled in this study; or
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81329.000.22 |