NCT04778553

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

Clinical Evaluation of the iMOST Analyzer - Matrix Study Comparing Capillary and Venous Whole Blood

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Essenlix Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

These studies demonstrate that the iMOST X-1 system yields equivalent results to the Horiba predicate system when using either capillary and venous blood specimens. Furthermore, there are three alternative methods of capillary blood sampling for the iMOST and all have direct applicability to the iMOST system. As has been published in the peer reviewed literature, different fingerstick sample collection methods yield slightly different CBC results, specifically the WBC and the WBC Differential. The iMOST employs an integrated software algorithm with which the use can employ site specific calibration constants to correctly match the selected capillary blood specimen to the venous specimen for the WBC test results. All three methods of blood collection are thus described in the "Instructions for Use".

Conditions

• Hematologic Tests

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	iMOST X-1 Hematology Analyzer	The X-1 is a point of care automated hematology analyzer

Timeline

• Start date: 2020-10-19
• Primary completion: 2020-12-09
• Completion: 2021-01-21
• First posted: 2021-03-03
• Last updated: 2021-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study