Performance Evaluation Study

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04618848

Enrollment

Registered

2020-11-06

Start date

2020-11-30

Completion date

2020-12-31

Last updated

2020-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematology

Keywords

Hematology

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.

Interventions

DIAGNOSTIC_TESTFingerstick blood draw

Each participant shall be pricked twice in order to perform CBC test

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Contacts

Primary ContactYochay Eshel

yochay@sightdx.com+972-52-8505747

Backup ContactTahel Naveh

tahel@sightdx.com+972-54-6412600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026