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

Completed

• Conditions: Hematologic Tests

• Registration Number: NCT04778553
• Lead Sponsor: Essenlix Corporation

Brief 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".

Study Timeline

• Study Start: 2020-10-19
• Primary Completion: 2020-12-09
• Study Completion: 2021-01-21
• Status Verified: 2021-02
• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-02-26
• Last Update Submitted: 2021-02-26
• Study First Posted: 2021-03-03
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• all clinic attendees

Exclusion Criteria

• unable to provide a venous and fingerstick blood specimen

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Method Comparison of CBC Results	October- December 2020	Blood Diagnostic Tests for CBC

Trial Locations

Locations (1)

Hunterdon Medical Center; 🇺🇸 Flemington, New Jersey, United States