Clinical Diagnostic Performance of the SpinChip hs-cTnI test
Research type
Research Study
Full title
Clinical Diagnostic Performance of the SpinChip high-sensitivity cardiac troponin I (SpinChip hs-cTnI) test
IRAS ID
334678
Contact name
Alasdair Gray
Contact email
Sponsor organisation
SpinChip Diagnostics
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
Research Summary: During a heart attack, cardiac muscle cells are injured and release the protein troponin I (cTnI) into the bloodstream. Hence, measuring cTnI levels in the blood is routinely performed in hospital laboratories to aid in the diagnosis of heart attack (Acute Myocardial Infarction [AMI]).
The SpinChip high-sensitivity cardiac Troponin I (hs-cTnI) test is intended for near-patient testing for subjects arriving at the hospital emergency department (ED) and Emergency Assessment areas with acute chest discomfort or other symptoms suggestive of Acute Myocardial Infarction (AMI). The results are obtained within 10 minutes.
The purpose of this study is to investigate the diagnostic performance of the SpinChip hs-cTnI test in the emergency department and Emergency Assessment areas, providing data regarding safety and accuracy of the novel testing system compared to the diagnostic performance of established clinically validated laboratory hs-cTnI assays.
Up to 1200 subjects arriving at the hospital emergency department and Emergency Assessment areaswith acute chest discomfort or other symptoms suggestive of Acute Myocardial Infarction (AMI) will be recruited to the study. Each subjects’ involvement in the study will be a screening/enrolment visit where venous blood samples will be collected from the subjects for measuring cTnI at up to 4 timepoints. A follow-up contact will be performed by the study site after 30 days to inquire about the subjects’ health status.
Summary of Results:
The aim of this research project was to assess the performance of a new near-patient test which measures cardiac troponin I in blood. Measurements of troponin in blood are used as an aid in the diagnosis of acute myocardial infarction (“heart attack”). The title of the study was "Clinical Diagnostic Performance of the SpinChip high-sensitivity cardiac troponin I (SpinChip hs-cTnI) test" and was performed by the company bioMérieux in collaboration with hospital emergency departments in six European countries (UK, Norway, Sweden, Denmark, Switzerland and Germany). The purpose of this study was to evaluate the performance of the SpinChip hs-cTnI test, as an aid in diagnosing a heart attack compared to tests that are already used routinely in hospitals. The SpinChip hs-cTnI test is intended to be performed close to the patient (near-patient test), and the results may be obtained within 10 minutes. The SpinChip test is processed and analysed using the SpinChip Analyzer.
A total of 1551 subjects participated in the study from July 2024 to September 2025. The enrolled participants were adult patients (>18 years old) that were admitted to the Emergency Department (ED) with symptoms (e.g., chest pain) which could be related to a heart attack. The patients followed the normal clinical routine and in addition blood samples for the study were collected at the time of arrival and then after 1, 2 and 3 hours after arrival at the ED. The troponin level in the blood samples was measured using the SpinChip test and the hospital’s standard troponin test. In addition, the patient was followed up with a telephone call 30 days after the hospitalization to record any new heart attacks and confirm that the patient was still alive. An independent committee composed of cardiologists also examined patient records, standard troponin test results and current medical guidelines to determine whether the patient had experienced a heart attack or not. The SpinChip test result was compared to the diagnosis determined by the independent committee for each study participant. The results from the SpinChip test were not used for medical treatment of the study participants at the time of their hospital visit, nor was it used by the independent committee to determine the final diagnosis.
The results from the study demonstrated that the (SpinChip hs-cTnI) test was able to diagnose heart attack with the same accuracy as the standard hospital and laboratory tests on the market. The tests also performs similarly for males and females.
Further the data from the study demonstrated that the SpinChip hs-cTnI test is safe to use. There were no harmful events that were linked to the SpinChip test or SpinChip Analyser reported during the study neither for the users nor for the subjects.
The conclusion from the study is that the SpinChip hs-cTnI test can be used as intended; as an aid to diagnose heart attack together and that it performs as well as other standard hospital tests currently used to diagnose heart attack. The data generated in the study will be used to obtain approval for use of this test in hospital emergency departments in the EU (CE-mark).
In this study, there was no direct benefit to the participants. The anticipated clinical benefits are for future patients where rapid, high sensitivity measurements of troponin may facilitate a faster diagnosis of a heart attack in the Emergency Department. In addition to the anticipated benefits for the patients, shortening both the patient’s time to diagnosis and length of stay at the emergency department may potentially lead to significant cost savings for the healthcare system. Thank you to all study participants who donated blood samples for the study.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
24/WM/0242
Date of REC Opinion
19 Dec 2024
REC opinion
Further Information Favourable Opinion