Primary objectiveThe objective of this study is to demonstrate the 12 month stability of cTnT in native serum, Li-heparin plasma and K2-EDTA plasma samples at -20 ± 5 °C, > 4 hours at 15 to 25 °C, > 24 hours at 2 to 8°C and > 12 months for…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sample stability acceptance criteria:
All measurements will be visualized in a scatter plot over time, as
relative/absolute change from baseline T0. Regression will be performed per
matrix. A linear regression analysis will be conducted to determine an
appropriate equation that models the percent recovery or absolute deviation as a
function of time. The best-fit model determined will be plotted on the
scatterplot and the regression equation, coefficient of determination (R2), and
one-sided 95% confidence limits for the model at each time point will be
reported.
Regression analyses will yield an estimation for slope and intercept as well as
one-sided 95% confidence intervals. Acceptance is assessed via the intercept of
the confidence interval of linear regression and the 90% or 110% limit (100% +-
most conservative acceptance limit).
Additional analysis as outlined above might be required for registration by
authority (FDA). As these requirements will become clarified after study end
these additional analysis will be conducted during registration phase of the
product under investigation.
Freeze and thaw acceptance criteria:
Mean measuring value of the four repetitions will be compared for each sample
using T0 (fresh never frozen) as well as T1 (sample stress period start) time
point. This comparison will refer to a one time freeze and thaw cycle including
a limited sample storage time. Based on the analyte concentration the following
acceptance criteria will be applied: LEoMR to 24.0 ng/L: <= 2.40 ng/L deviation,
>24.0 ng/L to HEoMR: <= 10 % deviation.
Secondary outcome
Prolonged sample stability evaluation for frozen storage conditions of up to 7
years.
Background summary
Sample stability information is part of the information provided in the method
sheet. Although it is required for the launch of the product, the requirements
for its determination vary from country to country. In the US, several specific
requirements apply as samples need to be native, fresh never frozen, and
determination of sample stability needs to be performed separately for each
sample type.
Therefore, a sample stability study will be performed to verify the stability
of cTnT for use with the Elecsys Troponin T hs Gen 6 assay. The MDPs for use
with the Elecsys Troponin Gen 6 hs has not yet been determined and will be
determined as part of the Reference Range Study (CIM RD005476). However, a
method comparison of the current Elecsys Troponin hs as well as the new assay
under investigation allow to estimate the future MDP range that is used in this
study to predominantly select samples within or around this important value
range. Furthermore the samples for sample stability testing should cover the
measuring range. The study will comprise data that should be used for the
Method Sheet showing sample stability for up to 12 months. Remaining samples
will be transferred to Roche for further evaluation of sample stability of
frozen specimens for up to 7 years.
Study objective
Primary objective
The objective of this study is to demonstrate the 12 month stability of cTnT in
native serum, Li-heparin plasma and K2-EDTA plasma samples at -20 ± 5 °C, > 4
hours at 15 to 25 °C, > 24 hours at 2 to 8°C and > 12 months for < -60°C as
well as - 15°C to - 25°C storage. Stability will be determined
for each sample type separately.
Additional Objective
For long term sample stability testing (up to 7 years) done at -15°C to -20°C
as well as < -60°C remaining samples will be shipped to Roche for further
analysis in a separate study setting.
Study design
Study Familiarization
In this part of the Study Protocol the site personnel should get acquainted
with the system and reagents, the experimental design and/or WebCAEv. If the
experiments performed in the Study Familiarization do not meet the target
acceptance criteria, the root cause has to be found before the other study
parts can start. The data of the Study Familiarization experiments are not used
for evaluation of performance claims.
Main Trial (sample collection)
Sample collection as outlined in section 9.2. of the research protocol.
Main Trial (sample measurement / stability evaluation)
Sample measurement as outlined in section 9.2 of the research protocol.
Intervention
For investigation of TnT hs levels (stability over time at various storage
conditions) up to 70 ml of blood will be taken one time.
Study burden and risks
This study is a non-interventional evaluation of an investigational in-vitro
diagnostic product and results will not influence any treatment decision.
Therefore, for purposes of this study the definition of an adverse event (AE)
is restricted to such related to the blood draw. The sites performing the blood
draw are experienced in their day-to-day use following the manufacturer*s
instructions of CE labelled routine equipment. Therefore, no AEs (except those
relating to the blood draw) are anticipated for this study.
The determination of troponine T helps cardiologists to predict and diagnose
heart diseases. A constant improvement of such assays helps to improve medical
decision making for upcoming patient generations. Since sample stability data
is a pre-requisite for product registration the risk of the participating
subjects might be justified by the future benefit of patients by an improved
troponine T assay.
Nonnenwald 2
Penzberg 82377
DE
Nonnenwald 2
Penzberg 82377
DE
Listed location countries
Age
Inclusion criteria
Lower end of the Measuring range to 4.8 ng/L; >= 3 samples
>4.8 to 7.2 ng/L, >= 2 samples
19.2 to 18.8 ng/L, >= 2 samples
113.6 to 170.4 ng/L, >= 2 samples
>4.8 to 170.4 ng/L, >= 3 samples
>170.4 to 3000 ng/L, >= 1 sample
>3000 to 6000 ng/L, >= 1 sample
8550 to 9500 ng/L (upper 10% of the measuring range), >= 1 sample
Sample appearance: non-hemolytic, non-icteric, non-lipemic
Written Informed consent given.
Subject age >= 21 years
Exclusion criteria
-Subject age < 21 years
-No written informed consent.
-Not able to provide 20 to 30 ml of blood (depending on the blood
collection tube type used), most preferred 2 or 3 times 20 to 30ml of
blood to collect more than one specimen type.
-Sample do not match requested analyte concentration.
-Sample do not match quality requirements (i.e. icteric, lipemic,
hemolytic)
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL81841.058.22 |