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 overview 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 opinion, examples of this kind of analytes) • Existence of reliable BV data 7

For each measurand Assign to “ outcome ” YES Do outcome data YES Are they valid? category exist? NO Assign to BV YES Do valid BV data category exist? NO Assign to the state-of- the-art category 8

20 most frequently requested serum measurands (decreasing order) These 20 tests represent • Creatinine • Urea about 50% of the work • ALT • CK of my Laboratory • AST • Total cholesterol • Glucose • Triglycerides • Potassium • Total protein • Sodium • LDH • Calcium • ALP • Gamma-GT • HDL-cholesterol • CRP • Uric acid • Total Bilirubin • TSH 9

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 CV I heterogeneity • Collaboration with TFG-BV for the prioritization and the sharing of BV data 10