Task and finish group Allocation of laboratory tests to different - - PowerPoint PPT Presentation

Task and finish group “Allocation of laboratory tests to different models for performance specifications” (TFG-DM).

Models defined by the EFLM Conference in Milano

• Model 1. Based on the effect of analytical

performance on clinical outcomes

• Model 2. Based on components of biological

variation of the measurand

• Model 3. Based on state-of-the-art

2

Statements of the Milano meeting

• “There is general agreement that some of these

[models] are better suited for certain measurands than for others.”

• “It is therefore recommended that a list be made

allocating measurands to different models.”

• “Preference should be given to models 1 and 2. In

some situations, it can be advantageous to combine the different models.”

• “Some measurands could have different performance

specifications defined when the test has multiple intended clinical applications.”

3

TFG - DM

• Terms of Reference: To allocate different tests to

different models recognized in the Strategic Conference Consensus Statement and to give an

• verview and a reason for why tests are

allocated to the different models.

• Deliverable: To produce a list of laboratory tests

allocated to the different performance specifications (starting with the most common) to be put on the EFLM website. To publish a paper describing the rationale behind listing the different tests in the different model groups.

4

Work-flow

• 1. Elaborate a strategy for allocating the

analytes to the different models:

– identify objective criteria – describe the rationale for those criteria

• 2. Apply the criteria to the most frequently

requested analytes (see next slide for the 20 most frequently requested serum measurands in my Institution)

5

1) Possible criteria

• 1. The measurand has a central role in

diagnosis and monitoring of a specific disease  outcome criteria;

• 2. The measurand has a high homeostatic

control  BV criteria;

• 3. Neither central diagnostic role nor

sufficient homeostatic control  state-of- the-art.

6

Criteria for applicability of BV data

(preliminary proposal, to be developed)

• Existence and grade of homeostatic control.

– For analytes without a real homeostatic control I expect high intra-individual variability, large differences in the BV of different individuals, large differences among results of BV studies (urinary measurands or inflammatory markers are, in my

• pinion, examples of this kind of analytes)
• Existence of reliable BV data

7

For each measurand

8

Do outcome data exist? YES Are they valid? YES Assign to “outcome” category NO Do valid BV data exist? YES Assign to BV category NO Assign to the state-of- the-art category

20 most frequently requested serum measurands (decreasing order)

• Creatinine
• ALT
• AST
• Glucose
• Potassium
• Sodium
• Calcium
• Gamma-GT
• CRP
• Total Bilirubin
• Urea
• CK
• Total cholesterol
• Triglycerides
• Total protein
• LDH
• ALP
• HDL-cholesterol
• Uric acid
• TSH

9

These 20 tests represent about 50% of the work

• f my Laboratory

How to proceed

• Discussion on the criteria

– How to identify the main clinical use of an analyte – How to interpret the existing BV data to evaluate the homeostatic control of the analyte. Which numbers will indicate excessive CVI heterogeneity

• Collaboration with TFG-BV for the

prioritization and the sharing of BV data

10