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ARCHITECT STAT High Sensitive Troponin I Assay · 1 trial · 2 indications
The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Area Under the Curve (AUC). The Area Under the Curve that was assessed, is used to determine the optimum clinical sensitivity and specificity for the ARCHITECT STAT High Sensitive Troponin-I assay. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).
The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Sensitivity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).
The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Specificity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).
The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Negative Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).
The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Positive Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).
| Arm | Type | Description |
|---|---|---|
| ARCHITECT STAT High Sensitive Troponin I Assay testing | EXPERIMENTAL | All subjects will have their blood tested by the investigational ARCHITECT STAT High SensitiveTroponin I assay. |
| Name | Type | Description |
|---|---|---|
| ARCHITECT STAT High Sensitive Troponin I Assay | DEVICE | Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay. Results obtained will be used to assess the prognosis of subjects for risk of ACM/MACE in the timeframes (30 days and 90 days) after the Emergency Department visit. Troponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit. |
Inclusion Criteria: * presenting to the Emergency Department with symptoms consistent with or suggestive of Acute Coronary Syndrome (ACS) defined as at least 5 minutes of chest pain (or symptoms consistent with myocardial ischemia) up to 6 hours prior to initial evaluation. * an Electrocardiogram (...
ARCHITECT STAT High Sensitive Troponin I Assay is used for the evaluation of patients with Acute Coronary Syndrome and Acute Myocardial Infarction. It is a diagnostic assay designed to measure high sensitive troponin I levels, which are biomarkers released during cardiac injury. The assay is intended to aid in the diagnosis and risk assessment of these cardiovascular conditions.
ARCHITECT STAT High Sensitive Troponin I Assay is developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker symbol ABT. Abbott is a global healthcare company that develops diagnostic assays and other medical products. The assay is part of Abbott's ARCHITECT line of diagnostic instruments and reagents.
ARCHITECT STAT High Sensitive Troponin I Assay is in Phase 3 clinical development. It is an investigational diagnostic assay, not yet approved by regulatory authorities. The Phase 3 trial, which has been completed, was designed to evaluate the assay's performance in patients with Acute Coronary Syndrome and Acute Myocardial Infarction.
ARCHITECT STAT High Sensitive Troponin I Assay has one completed clinical trial registered under NCT01608100, titled 'Evaluation of a New Cardiac Biomarker Assay'. This Phase 3 study enrolled 1101 participants in the United States, including adults aged 18 years and older with Acute Coronary Syndrome or Acute Myocardial Infarction. The trial was not randomized, double-blind, or controlled.
ARCHITECT STAT High Sensitive Troponin I Assay is a diagnostic test that measures high sensitive troponin I, a protein released into the blood when heart muscle is damaged. Elevated levels indicate myocardial injury, helping clinicians diagnose Acute Coronary Syndrome and Acute Myocardial Infarction. The assay is designed for use with Abbott's ARCHITECT immunoassay analyzers.