Analytical and Clinical Performance Testing Plan

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

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