The objective of this evaluation is to confirm the specifications for limit of detection, lot-to-lot variation and influence of the sample material (Li-heparin vs. EDTA blood) of TROPT Sensitive in comparison to Elecsys TnThs and for intermediate…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary goal in this study is to determine the limit of detection of TROPT
Sensitive.
Secondary outcome
Beside the limit of detection (C95) further cut-points will be determined with
the overall data of the method comparison to Elecsys TnThs by Probit analysis
The lot-to-lot variability will be determined with the pairs of values
resulting from the parallel measurement of different TROPT Sensitive lots in
the method comparison experiment
The comparability of heparin blood to EDTA blood will be determined with the
pairs of values resulting from the parallel measurement of different TROPT
Sensitive lots with these two sample materials in the method comparison
experiment
The intermediate precision of TROPT Sensitive and of cobas h 232 will be tested
Background summary
The medical need of cardiac troponin T determination is well described and
TROPT Sensitive is a well-established assay. The original performance
evaluation of TROPT Sensitive was carried out from April to November 1996 at
five study sites with two lots. At this time the definition of acute myocardial
infarction and unstable angina pectoris was different to the current
definition. Therefore, the intended scope of TROPT Sensitive as an aid in
diagnosis of myocardial infarction has to be validated with the current
clinical setting using the current patient population applying the latest
definition for the diagnoses and conducted with the specific users of the
assay. All these have changed since 1996. Therefore, the assay has to be
re-evaluated to fulfill the requirement for certification according to IVDR.
The re-determination of the intermediate precision of TROPT Sensitive in a
general ward will be used to determine the intermediate precision for the
assays of the cobas h 232 system as well.
Study objective
The objective of this evaluation is to confirm the specifications for limit of
detection, lot-to-lot variation and influence of the sample material
(Li-heparin vs. EDTA blood) of TROPT Sensitive in comparison to Elecsys TnThs
and for intermediate precision of the assay. Supportively, in all method
comparisons CARDIAC POC Troponin T is measured.
Furthermore, demographic data and clinical performance figures of TROPT
Sensitive will be evaluated in an explorative analysis which is done for
information only.
In the reference range part of the study it shall be shown that all samples
that are below the 99th percentile of the reference method Elecsys TnThs are
found negative with TROPT Sensitive.
For cobas h 232 it shall be demonstrated that reliable results can be obtained
by near patient users with basic skills in a general ward using Roche CARDIAC
POC Troponin T, Roche CARDIAC proBNP+ and Roche CARDIAC D-Dimer.
Study design
Due to the observational study design no diagnosis will be made, no treatment
will be initiated and no medical decision will be taken.
From patients with chest pain complaints that have consented to participate 20
ml additional blood is drawn into EDTA or LiHeparine tubes. These materials
will be used to perform analytical and diagnostic validation of the troponin
tests.
Study burden and risks
The only burden for all patients is an additional loss of 20 ml of blood. In
some cases collected during a venipuncture for routine care, in other cases an
additional venipuncture is necessary.
Sandhofer Str. 116
Mannheim 68305
DE
Sandhofer Str. 116
Mannheim 68305
DE
Listed location countries
Age
Inclusion criteria
New-onset typical chest pain and other symptoms suggestive of acute coronary
syndromes
Exclusion criteria
Age <21 years
Self-declared pregnancy
Breast-feeding women
Relative or spouse of the investigator
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73090.100.20 |