NCT04618848

Performance Evaluation Study

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Sight Diagnostics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematology

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Fingerstick blood draw	Each participant shall be pricked twice in order to perform CBC test

Timeline

• Start date: 2020-11-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2020-11-06
• Last updated: 2020-11-06

Regulatory

• FDA-regulated device study