Atellica VTLi sepsis biomarker sample comparison study

Conditions: infectious diseases
sepis
10019815

Registration Number: NL-OMON51331

Lead Sponsor: Siemens Healthineers

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

• Patients >= 18 years old
• Patients presenting at the hospital with suspected/ diagnosed infectious
disease
• Patients able and willing to provide written informed consent

Exclusion Criteria

• Patients younger than 18 years
• Patients requiring emergency treatment
• Patients with cognitive impairment or inability to understand study
information
• Patients previously enrolled in this study
• Pregnant or breastfeeding women

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To compare Atellica VTLi Sepsis values from capillary whole blood to<br /><br>anticoagulated whole blood and plasma from venipuncture.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To correlate the blood and plasma outcomes on the Atellica VTLi Sepsis tests to<br /><br>the corresponding biomarker levels measured on the routine analyzers in the<br /><br>laboratory. Also, to evaluate results of the sepsis tests as function of<br /><br>hematocrit (Hct) values.</p><br>