During a heart attack, the protein troponin I is released from the heart muscle into the bloodstream. Measurements of cardiac troponin in blood are used as an aid in the diagnosis of heart attack. The SpinChip hs-cTnI test is a new high-sensitive test for measuring the amount of cardiac troponin I in the bloodstream as an aid in the diagnosis of heart attack. The purpose of this study is to establish the precision of the SpinChip hs-cTnI test when using Li-Heparin plasma and whole blood samples in the hands of the intended user in the intended use setting at multiple sites.
Cardiac troponins are widely used as a biomarker to aid in the diagnosis of acute myocardial infarction (AMI). These structural proteins are essential in regulating contraction in cardiac muscle cells, and they are sensitive and specific biochemical markers of myocardial damage. During a heart attack, cardiac muscle cells are injured and release the cardiac marker troponin I (cTnI) into the bloodstream. High-sensitive troponin tests may detect the increase of cardiac troponin in blood within hours after the symptoms of a heart attack has started. The SpinChip high-sensitivity cardiac troponin I (hs-cTnI) test is a new high-sensitive test for measuring troponin I in blood samples, and the analysis may be performed close to the patient (near-patient test). The results may be obtained within 10 minutes, compared to approximately 1 hour for normal laboratory analysis. The SpinChip Platform consists of the SpinChip hs-cTnI test and the SpinChip Analyzer and may be used at the emergency department to evaluate patients presenting with symptoms of acute myocardial infarction (chest pain). The test can use blood from finger prick or venous blood samples, either as whole blood or separated into plasma. This multisite prospective, observational, non-randomized validation study will establish the repeatability, within-laboratory precision and reproducibility of the SpinChip hs-cTnI test for Li-Heparin plasma and repeatability for Li-Heparin whole blood samples. Potential subjects will be identified based on clinical cardiac troponin levels obtained from medical records at the individual study site.
Study Type
OBSERVATIONAL
Enrollment
37
SpinChip Platform, consisting of the SpinChip hs-cTnI test (self-contained cartridge) and SpinChip Analyzer (instrument)
Akershus University Hospital, Akershus Clinical Research Center (ACR)
Lørenskog, Akershus, Norway
Vestre Viken Bærum Hospital
Sandvika, Akershus, Norway
SpinChip Diagnostics
Oslo, Oslo, Norway
Precision of the SpinChip hs-cTnI test using Li-heparin plasma and whole blood samples
Calculation of repeatability, within-laboratory precision and reproducibility of the SpinChip hs-cTnI test using cTnI results obtained from analysis of Li-Heparin plasma. Calculation of repeatability of the SpinChip hs-cTnI test using cTnI results obtained from analysis of Li-Heparin whole blood.
Time frame: 1 day
Precision of the recommended commercially available control material
Calculation of repeatability, within-laboratory precision and reproducibility of the SpinChip hs-cTnI test using cTnI results obtained from analysis of commercial control material
Time frame: 1 day
Incidence of AEs, ADEs and DDs
Evaluate safety of the SpinChip Platform, as measured by adverse events (AEs), adverse device effects (ADEs) and device deficiencies (DDs).
Time frame: 1 day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.