Clinical Trial to Evaluate MDW for Early Detection of Sepsis
This study is intended to clinically verify Monocyte Distribution Width (MDW) parameter of DxH 900 Hematology Analyzer for use in early detection and risk assessment of sepsis, severe sepsis, and septic shock in critically ill patients in Emergency Department (ED). This study is also aimed to provide study supporting data for the product to be marketed in China.
- EligibilityCriteria: Inclusion Criteria:  Adult subjects (18-89 years) presenting to ED. CBC with Differential performed upon presentation as part of standard of care. Subject scheduled for at least 12 hours follow-up during ED (or inpatient, if admitted to the hospital) visit Signed the informed consent form  Exclusion Criteria:  Subjects previously enrolled in this study (i.e., re-enrollment to this study is not allowed). The subject is discharged from the hospital within 12 hours after ED visit - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 89 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients of any race and ethnicity can be enrolled to this study. Patients with a prior chronic immunosuppressive disease and subjects with hematological malignancy can also be enrolled. This study requires at least 250 sepsis subjects and 1,100 non-sepsis subjects. - SamplingMethod: Non-Probability Sample