hart attack, acute myocardial infarction
Conditions
Interventions
Elecsys TnI hs and Elecsys cMyBPC assays.
Sponsors
Roche Diagnostics GmbH
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Subjects need to be > 21 years of age. Subjects need to be able and willing to give informed consent as well as to provide at least 15 to 20 ml of blood (up to 69.5 ml). Subjects are selected by phycisian to provide samples with an analyte concetration according to the scheme below:TnI hs> 1.25 to 4 ng/L > 1 sample> 4 to 10 ng/L > 2 samples > 35 to 70 ng/L > 2 sample > 100-150 ng/L > 2 sample > 4 to 150 ng/L > 2 sample> 150 to 1000 ng/L > 1 sample> 1000-4000 ng/L > 1 sample> 4000 ng/L to 6000 ng/L, > 1 sample > 6000 ng/L to 9000 ng/L > 1 sample> 9000 ng/L to 10000 ng/L > 2 sample (upper 10% of the measuring range) cMyBP-C4 to 10 ng/L; > 1 sample > 8 ng/L to 40 ng/L, > 4 samples > 40 ng/L to 800 ng/L, > 2 samples> 800 to 4000 ng/L, > 2 samples> 4000 to 12800 ng/L, > 2 samples> 12800 ng/L to 19200 ng/L, > 1 sample > 19200 to 27000 ng/L, > 1 sample> 27000 ng/L to 30000 (upper 10% of the measuring range), > 2 samples
Exclusion criteria
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 25ml 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Sample stability is assessed by calculating the sample recovery after sample stress is applied. All time points will be compared to T0 (fresh never frozen, measured within 4 hours of blodd draw).Sufficient recovery of the analyte indicates sample stability for the analyte under the applied test condition with the product under investigation. Acceptance criteria are:cMyBP-C C1: 4 to = 10 ng/L, ± 2 ng/L C2: > 10 to = 200 ng/L, ± 20 % C3: > 200 ng/L to 30000 ng/L, ± 15 % TnI hs C1: 1.25 to = 5 ng/L, ± 1 ng/L C2: > 5 to = 60 ng/L, ±20 % C3: > 60 ng/L to 10 000 ng/L, ± 15 % | — |
Countries
Netherlands
Contacts
Public ContactHD Donner
Roche Diagnostics GmbH
Outcome results
None listed