Evaluation of MDW for Early Detection of Sepsis, Clinical Validity
Evaluation of MDW for Early Detection of Sepsis, Clinical Validity
The purpose of this study is to confirm the clinical validity and the performance of the
 Monocyte Width Distribution (MDW) parameter to detect the development of sepsis in a
 prospective study of Emergency Department (ED) adults who have blood draw including Complete
 Blood Count with differential (CBC-DIFF) ordered upon presentation in a Spanish & French
 hospital and to verify cut-off for Tri-potassium ethylenediaminetetraacetic acid (K3EDTA).
To confirm the clinical validity and performance of the Monocyte Width Distribution (MDW)
 parameter to detect the development of sepsis in a prospective study of ED adults who have
 blood draw including CBC with Differential ordered upon ED presentation. Septic patients are
 identified as those with values equal to or above the MDW threshold and non-septic patients
 are those with MDW values below the threshold. As the anticoagulant used at the sites is
 K3EDTA, the cut-off value will be assessed using sepsis cases and all corresponding
 non-sepsis to confirm optimal cut-off.

 To explore the added value of this parameter in a patient diagnostic pathway that includes
 the use of procalcitonin (PCT) or C reactive protein (CRP) for the identification of septic
 patients All enrolled subjects will have PCT/ CRP assay performed per protocol Plasma will be
 aliquot and stored frozen for subsequent testing at Beckman Coulter for other sepsis
 biomarker tests (additional PCT& CRP tests and interleukin-6 (IL-6) on the sponsor's devices
Inclusion Criteria:

 -  CBC-DIFF upon presentation

 -  Adults (18-89) of all races & ethnicities

 -  Signed Informed Consent

 Exclusion Criteria:

 -  Previously enrolled

 -  Incomplete Informed Consent

 -  Subject discharged <4 hours from presentation

 -  PCT or CRP not performed per protocol

 -  Pregnancy

 -  Prisoners

 -  Subjects Under Custody or Guardianship