Performance Evaluation Study

• Conditions: Hematology
• Interventions: Diagnostic Test: Fingerstick blood draw

• Registration Number: NCT04618848
• Lead Sponsor: Sight Diagnostics

Brief Summary

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

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 Timeline

• Status Verified: 2020-11
• Study Start: 2020-11
• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-02
• Last Update Submitted: 2020-11-02
• Study First Posted: 2020-11-06
• Last Update Posted: 2020-11-06
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult Oncology Patients	Fingerstick blood draw	Adult oncology patients

Primary Outcome Measures

Name	Time	Method
CBC Comparison	Immediately after sample collection is completed	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