Performance Evaluation Study

Performance Evaluation Protocol for Sight Diagnostics' OLO CBC Analyzer by Ichilov Oncology Daily Care Center

This study aims to establish OLO's performance accuracy of CBC results for finger prick samples across the OLO reportable range, and particularly around relevant medical decision points

Study Overview

• Status: Unknown
• Conditions: Hematology
• Intervention / Treatment: Diagnostic test: Fingerstick blood draw

Detailed Description

This study aims to establish OLO's performance accuracy of CBC results for finger prick samples across the OLO reportable range, and particularly around relevant medical decision points.

The evaluation will include two studies:

1. A matrix study will compare a capillary sample collected via finger prick with a venous sample collected into a blood tube, both scanned on OLO.
2. A method comparison study will compare Sight OLO to the site reference analyzer using a venous sample collected into a blood tube.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Oncologic patient

Description

Inclusion Criteria:

• Blood samples will be collected from oncologic patients older than 18 years old arriving at the oncologic daily care center of Ichilov hospital, with predefined normal and abnormal blood counts

Exclusion Criteria:

• Patient younger than 18 years old
• Visibly hemolyzed specimens (sample plasma should be checked for hemolysis by technician while selection of specimen from tube racks).
• Visibly clotted specimens (Reasonable to assume that samples processed with clinical reported results are not clotted).
• A sample that is not successfully scanned on OLO within 3 attempts (e.g. rejected due to irregular cell morphology, or microscopically visible hemolysis).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult Oncology Patients; Adult oncology patients	Diagnostic test: Fingerstick blood draw; Each participant shall be pricked twice in order to perform CBC test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CBC Comparison	Comparison between CBC results obtained from the Sight OLO and the reference device in venous and capillary samples covering medical decision points relevant to onclology patient	Immediately after sample collection is completed

Collaborators and Investigators

• Sponsor: Sight Diagnostics
• Collaborators: Tel Aviv Medical Center
• Investigators: Principal Investigator: Yochay Eshel, Sponsor GmbH

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (ACTUAL): November 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Hematology
• Other Study ID Numbers: PR0156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No