Analytical and Clinical Performance Testing Plan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

679 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-20

Study Completion Date

2019-08-25

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Hematology Hematologic Test

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hematology Analyzer - OLO

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.

Hematology Analyzer - OLO

Intervention Type DEVICE

Complete blood counts from OLO will be determined from analysis of whole blood samples

Hematology Analyzer - Predicate

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.

Hematology Analyzer - Predicate

Intervention Type DEVICE

Complete blood counts from Predicate will be determined from analysis of whole blood samples

Interventions

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Hematology Analyzer - OLO

Complete blood counts from OLO will be determined from analysis of whole blood samples

Intervention Type DEVICE

Hematology Analyzer - Predicate

Complete blood counts from Predicate will be determined from analysis of whole blood samples

Intervention Type DEVICE

Eligibility Criteria

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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

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

* 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

Minimum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes