Near Patient Molecular Testing in Sepsis

The ability of SeptiCyte RAPID to differentiate sepsis from infection-negative systemic inflammation will be determined using retrospective physician diagnosis performed by an external panel of three physicians not involved with the care of the patients.

Inclusion criteria

• ≥18 years old on the date of ICU admission
• Systemic Inflammatory Response Syndrome (SIRS) present, as defined by the presence of two or more of the following:

• Temperature > 38°C or < 36°C
• Heart Rate > 90 beat/min
• Tachypnea > 20/min or PaCO2 < 32 mmHg
• WBC count > 12 000/mm3 or < 4 000/mm3 or > 10% immature neutrophils (bands)
• Consent to study inclusion, either by patient or legal surrogate before study-related sample processing
• Study sample collection within 24 hours of ICU admission order

Exclusion criteria

• Age less than 18 years old on the day of ICU admission
• No order to admit to ICU
• Not physically admitted to ICU
• Commencement of non-prophylactic antibiotics ≥ 24 hours prior to ICU admission
• Study sample collection > 24 hours from ICU admission order
• No clinical cultures or serologic tests obtained when sepsis was suspected
• Elective cardiac surgery patients with an expected duration in ICU of less than 24 hours
• Transfer from another ICU where subject was admitted for ≥ 24 hours.