IVDR Performance Evaluation TROPT Sensitive and Intermediate Precision cobas h 232

IVDR Performance Evaluation TROPT Sensitive and Intermediate Precision cobas h 232 - Performance evaluation TROPT Sensitive en cobas h 232

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49463

Enrollment

250

Registered

2020-04-23

Start date

2020-07-09

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart infarction myocardial infarction

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: New-onset typical chest pain and other symptoms suggestive of acute coronary syndromes

Exclusion criteria

Exclusion criteria: Age

Design outcomes

Primary

Measure	Time frame
The primary goal in this study is to determine the limit of detection of TROPT Sensitive.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Netherlands

Outcome results