palermo – april 26, 2014 controlling the quality of diagnostic tests e. bravi

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Palermo – April 26, 2014 Controlling the quality of diagnostic tests E. Bravi

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Page 1: Palermo – April 26, 2014 Controlling the quality of diagnostic tests E. Bravi

Palermo – April 26, 2014

Controlling the quality of diagnostic tests

E. Bravi

Page 2: Palermo – April 26, 2014 Controlling the quality of diagnostic tests E. Bravi

Palermo – April 26, 2014

Precision & Accuracy

In the fields of science, engineering, industry, and statistics, the ACCURACY of a measurement system is the degree of closeness of measurements of a quantity to that quantity's actual (true) value.  

The PRECISION of a measurement system, related to reproducibility and repeatability, is the degree to which repeated measurements under unchanged conditions show the same results.

Although the two words, precision and accuracy, can be synonymous in colloquial use, they are deliberately contrasted in the context of the scientific method.

Page 3: Palermo – April 26, 2014 Controlling the quality of diagnostic tests E. Bravi

Palermo – April 26, 2014

Precise and accurate

Precise

Accurate

Neither precise, nor accurate

Precision and accuracy

Page 4: Palermo – April 26, 2014 Controlling the quality of diagnostic tests E. Bravi

Palermo – April 26, 2014

Purpose of the exercise

To check how the performance of different test results may influence the follow-up of patients submitted to a Gluten Free Diet in various clinical settings.

Page 5: Palermo – April 26, 2014 Controlling the quality of diagnostic tests E. Bravi

Palermo – April 26, 2014

Materials available

7 vials containing ready-to-use samples. Samples must not be diluted Each sample has a different anti-tTG concentration Anti-tTG concentration is unknown

Page 6: Palermo – April 26, 2014 Controlling the quality of diagnostic tests E. Bravi

Palermo – April 26, 2014

Protocol

1. Each centre will be assigned a code by MediCel

2. Register data results into the provided spreadsheet

3. Complete the spreadsheet and send it back to the evaluation centre

4. The evaluation centre will provide all participants with overall and their results

Page 7: Palermo – April 26, 2014 Controlling the quality of diagnostic tests E. Bravi

Palermo – April 26, 2014

Assay Protocol

1. Allow all reagents to reach room temperature

2. Run your own assay as usual

3. Include unknown samples as ready-to-use specimens

4. Register data results into the provided spreadsheet

Page 8: Palermo – April 26, 2014 Controlling the quality of diagnostic tests E. Bravi

Palermo – April 26, 2014

Page 9: Palermo – April 26, 2014 Controlling the quality of diagnostic tests E. Bravi

Palermo – April 26, 2014

Page 10: Palermo – April 26, 2014 Controlling the quality of diagnostic tests E. Bravi

Palermo – April 26, 2014

How to report results

Page 11: Palermo – April 26, 2014 Controlling the quality of diagnostic tests E. Bravi

Palermo – April 26, 2014

Interpretation

Results will be used as follows:

All values:To generate a consensus Mean.To define acceptability range (Mean ± 2 St. Dev.)

and for each method:To calculate Mean and Standard Deviation

Page 12: Palermo – April 26, 2014 Controlling the quality of diagnostic tests E. Bravi

Palermo – April 26, 2014

Overall data - Example of graph

+2 St Dev

Mean

-2 St. Dev

* * * * * * * * * *

1 2 3 4 5 6 7 8 9 10

Cumulative Mean

* Your lab

Lab #

Page 13: Palermo – April 26, 2014 Controlling the quality of diagnostic tests E. Bravi

Palermo – April 26, 2014

Questions?

Thanks for your attention