Compare Atellica VTLi reference plasma separation membrane with at least one alternative plasma separation membrane using hs-cTnI values from capillary whole blood from fingerstick, Li-Hep whole blood and plasma from venipuncture.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The differences between the filters will be analysed using Passing-Bablok
regression, according to CLSI EP09c from the Clinical and Laboratory Standards
Institute. The parameter to be assessed is the significance of the
Passing-Bablok regression, which is performed for each different sample type.
Additionally, for each sample type, the measurement results of the filters
should demonstrate a correlation coefficient (R) of at least 0.95
Furthermore, the venous whole blood and plasma results as a function of
hematocrit for the alternative filter(s) will be analyzed.
Secondary outcome
not applicable
Background summary
The Atellica VTLi Test System, including the analyzer, associated disposable
single- use hs-cTnI Reagent Cartridges, docking station and service software,
are already CE marked IVD products. The Atellica VTLi hs-cTnI Reagent
Ccartridge uses a filter membrane to separate the plasma and the blood cells.
The CE marked cartridges use membranes of a single supplier/production
location. Differences between suppliers and/or production locations can lead to
variation in assay performance of the membranes.
This study is designed to compare membranes from different production locations
and/or manufacturers.
Study objective
Compare Atellica VTLi reference plasma separation membrane with at least one
alternative plasma separation membrane using hs-cTnI values from capillary
whole blood from fingerstick, Li-Hep whole blood and plasma from venipuncture.
Study design
This study requires the following procedures to be conducted: at least 50
patients will be included, with cTnI concentrations distributed over the
measurement range. A maximum of 100 patients will be included to fill the
desired ranges. Part of the testing will be done near the bedside of the
patient and part will be done at the central laboratory.
For each patient, the following sample sources will be collected:
• Capillary whole blood from fingerstick with an uncoated transfer device
• Li-Hep venous whole blood
• Li-Hep venous plasma (generated from the Li-Hep venous whole blood)
One (1) replicate needs to be tested for the capillary samples per plasma
separation membrane. A maximum of 2 finger sticks per patient will be performed.
Two (2) replicates need to be tested per membrane per patient for both venous
plasma and venous whole blood samples.
The time at which each sample is obtained and tested will be recorded.
Subjects will be selected for hs-cTnI concentrations across the measurement
range.
The number of sample sets in the different ranges are targeted at:
• >=15 sample sets 2-40 ng/L, of which at least 5 around the medical decision
point: 16-40 ng/L
• >=8 sample sets 41-200 ng/L
• >=8 sample sets 201-1250 ng/L
Hematocrit (Hct) values will be obtained from the Laboratorium Information
system.
The Atellica VTLi hs-cTnI test results must not be used for patient diagnosis
or treatment, and are for study purposes only.
Study burden and risks
This is a low risk IVD study. All blood samples will be collected using
standard blood collection techniques used for venipuncture and fingerstick.
Most of the patients will have an indwelling cannula from which blood samples
are drawn. In some cases an additional venipuncture is required to be performed
as part of this study. The fingerstick sample, taken only for study purposes,
may result in a small pain at the side of the fingertip, but this pain is
usually of short duration and tolerated very well.
Troponin tests available on central lab-systems carry the burden of associated
logistics to get a sample to the lab and the result reported back to the
physician, which significantly impacts the time to a disposition decision.
Point-of-care (POC) assays have the potential to shorten this turn-around time,
enabling more rapid decision making. Using this specific POC analyzer,
biomarker results can be obtained within 10 minutes, aiding in the early
diagnosis of Myocardial Infarction (MI).
High Tech Campus 29
Eindhoven 5656 AE
NL
High Tech Campus 29
Eindhoven 5656 AE
NL
Listed location countries
Inclusion criteria
• >=22 years old
• Patients presenting at the coronary care unit with suspected/diagnosed ACS
and thus having suspected elevated cTnI values
• Patients willing and able to sign informed consent form
Exclusion criteria
• Patients younger than 22 years
• Patients requiring emergency treatment
• Patients with cognitive impairment or inability to understand study
information
• Patients previously enrolled in this study
• Pregnant or breastfeeding women
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 | NL81218.075.22 |