Analytical and Clinical Performance Testing Plan

Completed

Conditions studied: Hematology, Hematologic Test

In brief

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.

Key facts

Study ID

NCT03595501

Run by

Sight Diagnostics

People needed

679

Starts

2018-06-20

Expected to finish

2019-08-25

Last updated by the study team

2021-03-04

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Columbia University — New York, New York, United States

Full record on ClinicalTrials.gov

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