NCT04458155

Li-Hep vs. Non-Li-Hep Coated Transfer Device

Sample Comparison With Siemens® Point-of-care Device for Cardiac Troponin I Assay by Using a Heparin Coated Transfer Device vs. Non-heparin Coated Transfer Device at the Emergency Department (Validation Study 2.0)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: VieCuri Medical Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This study is a prospective, diagnostic, cohort study within the standard care of acute coronary syndrome (ACS) patients. It compares the analytical performance of Siemens® point-of-care high sensitive troponin I testing in venous, plasma and capillary sample types. The investigators hypothesize that there is a good correlation between the Siemens® POC HS cTnI assay results for the three sample types and that the bias between different POC sample types reduces from \~10% to ≤ 5% when using heparinized transfer device for the capillary sample.

Detailed description

In September 2019, the validation study 1.0 started, in which the cTnI result of the Siemens POC device on three sample types are compared. Interim analysis of the sample comparison was performed by regression analysis using Passing and Bablock, and calculating the Pearson correlation coefficient. The Li-hep Plasma vs Li-hep venous blood show a very good correlation of 1.00-1.03 with an R of \>0.99, so the results between these sample types can be used interchangeably. For the capillary sample vs the Li-hep sample (both blood and plasma) the slope is 8-12% higher. With a 8-12% higher response, the capillary test results may not be interchangeably used with the other 2 sample types. It is remarkable that capillary samples give a higher response, since it was anticipated that the result may be slightly lower due to the possible dilution by interstitial fluid. The investigators hypothesize that the presence of the Li-heparin anti-coagulant in the venous draw lead to a slight reduction of the apparent cTnI concentration. By using a heparin coated transfer device for the capillary samples instead of an uncoated transfer device, this hypothesis will be tested.

Conditions

• Acute Coronary Syndrome
• Chest Pain
• Myocardial Infarction
• Cardiac Ischemia

Interventions

Type	Name	Description
DEVICE	Siemens® Point-of-care high sensitive troponin I analyzer	Point-of-care (POC) high sensitive troponin I (HS cTnI) analysis in whole blood, plasma and capillary whole blood with the Siemens® device.

Timeline

• Start date: 2020-06-18
• Primary completion: 2020-12-19
• Completion: 2021-04-01
• First posted: 2020-07-07
• Last updated: 2022-06-10

Locations

1 site across 1 country: Netherlands