Performance Evaluation Study

Sight Diagnostics

Status

Unknown

Conditions

Hematology

Treatments

Diagnostic Test: Fingerstick blood draw

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04618848

PR0156

Details and patient eligibility

About

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

Full 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:

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.
A method comparison study will compare Sight OLO to the site reference analyzer using a venous sample collected into a blood tube.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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).