Analytical and Clinical Performance Testing Plan

Sight Diagnostics

Status: Completed

Conditions: Hematology; Hematologic Test

Treatments: Device: Hematology Analyzer - OLO; Device: Hematology Analyzer - Predicate

Study type: Observational

Funder types: Industry

Identifiers

NCT03595501

PR00014

Details and patient eligibility

About

Clinical and analytical tests will be performed based on risk assessment and system specifications to verify that the performance of the investigational device is in accordance with its specifications.

Full description

Comparison and precision studies will be conducted in up to 5 clinical sites in Israel and the US, and include:

• Precision
• Sample Matrix Comparison
• Method comparison study and flagging analysis
• Reference interval range

Enrollment: 679 patients

Sex: All

Ages: 3+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

For Residual Samples:

• Specimen obtained by venipuncture or finger prick and collected into tubes normally used by the site
• Patient is at least 3 months of age
• Samples within 8 hours from phlebotomy

For Prospectively collected samples:

• Subject is at least 22 years of age
• Non-diseased individuals or, for specific studies, individuals with blood count ranges to cover indicated medical decision points and ranges
• Samples within 8 hours from phlebotomy

Exclusion criteria

Exclusion criteria post blood draw and pre sample scan - For whole blood samples:

• Visibly hemolyzed or clotted specimens
• Specimens with insufficient blood volume to complete the procedure
• Samples older than eight hours

Exclusion criteria post sample scan:

• Instrument failure or sample rejected by the instrument due to system error or sample mishandling
• The daily quality control sample measurements indicate that the assay run is outside the specifications for the instrument
• Operator related error documented in the study records
• Failure to adhere to study specifics or protocols

Trial design

679 participants in 2 patient groups

Hematology Analyzer - OLO

Description:

The investigational device is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening capillary or venous whole blood samples.

Treatment:

Device: Hematology Analyzer - OLO

Hematology Analyzer - Predicate

Description:

The predicate device is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical and reference laboratories.

Treatment:

Device: Hematology Analyzer - Predicate