Quantitative Validation Overview



|Author: |Document Number: |Equ51-03 |

|Validation Committee | | |

| |Effective (or Post) Date: |19-Dec-2008 |

|Review History |Date of last review: |13-Feb-2020 |

| |Reviewed by: |Heidi Hanes |

|SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific |

|processes and/or specific protocol requirements. Users are encouraged to ensure compliance with local laws and study protocol |

|policies when considering the application of this document. If you have any questions contact SMILE. |

SMILE Precision Requirements-Chemistry

|SMILE Precision Requirements-Chemistry |Document Number |230 |

| |Effective Date |19 Dec 2008 |

|Subject |Page |1 of 1 |

|Guidelines for performing precision testing on a chemistry analyzer | | |

| |Supercedes |New |

|Review History |Date of last review: |19 Dec 2008 |

| |Reviewed by: |Erin Gover |

| |Version # [0.0] |Revision Date |Description (notes) |

|Revision History | |[dd/mm/yy] | |

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SMILE Chemistry Precision Requirements

PRECISION is reproducibility - the agreement of the measurements of replicate runs of the same sample. Replication experiments are performed to estimate the imprecision or random error of the analytical method.

I. Short -Term (Within Run/Day)

A. Sample:

1. Two levels (Low / High or Normal / Abnormal)

2. Patient or quality control

B. Testing: Run each sample 20 times on the same run, if possible, or at a minimum within the same day.

C. Acceptability criteria:

1. Calculate the coefficient of variation (CV) for each level using 20 data points.

2. Compare to manufacturer’s stated precision claims found in the package insert.

3. If manufacturer’s precision cannot be met, it is acceptable to attain precision that is ................
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