Clinical Evaluation of the iMOST-X1 Hematology Analyzer - Matrix Study

Completed

Conditions studied: Hematologic Tests

In brief

This is a method comparison study for an in vitro diagnostic device. The device is a point of care automated hematology analyzer which measures CBC parameters with a small drop of venous or capillary, e.g., fingerstick blood. The study compared the CBC results from the test device, the Essenlix iMOST X-1 to the predicate laboratory based Horiba Pentra 60C+ analyzer. The CBC parameters were hemoglobin, White Blood Cells (WBC) and the WBC Differential for Granulocytes, Neutrophils, Lymphocytes and Monocytes. The study subjects were patient donors (age 18 and older) attending the hospital clinic from whom Informed Consent had been received.

Key facts

Study ID

NCT04778553

Run by

Essenlix Corporation

People needed

60

Starts

2020-10-19

Expected to finish

2021-01-21

Last updated by the study team

2021-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• all clinic attendees

You may not qualify if…

• unable to provide a venous and fingerstick blood specimen

Where it is running

• Hunterdon Medical Center — Flemington, New Jersey, United States

Full record on ClinicalTrials.gov

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