acute myocardial infarction heart attack
Conditions
Interventions
For investigation of TnT hs levels (stability over time at various storage
conditions) up to 70 ml of blood will be taken one time.
Sponsors
Roche Diagnostics GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: -Subject age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 24.0 ng/L to HEoMR: | — |
Secondary
| Measure | Time frame |
|---|---|
| Prolonged sample stability evaluation for frozen storage conditions of up to 7 years. | — |
Countries
Netherlands
Outcome results
None listed