Precision of autoantibody assays in clinical diagnostic laboratories: What is the reality?

International audienceBackgroundISO 15189 accreditation remains a challenge for specialized laboratories. In the field of autoimmunity, beside the crucial problem of absence of standardization, laboratories have to manage the analytical performances of the large panel of assays in terms of sensitivity and specificity, but also on their measurement precision for which no reference values are available on biorepositories.MethodsAs an initiative of the French EASI (European Autoimmunity Standardization Initiative) group, French clinical diagnostic laboratories were requested to participate in a survey aiming to analyze the coefficients of variation (CVs) of intra-run and inter-run variability obtained with assays quantifying 14 different autoantibodies. Two performance goals corresponding to the 90th percentile and the 50th percentile (lowest CV values reached by 90% and 50% of laboratories respectively) defined for three levels of concentration were calculated. The impact on the assay performances of the number of measurements, of the nature of the internal quality control (IQC) and the type of immunoassay, was also analyzed.Results414 and 616 values of intra-run and inter-run CVs were collected, respectively. The 50th percentile performance goals were comprised between 1.0% and 8.9% for the intra-run CVs, and between 1.8% and 14.6% for the inter-run CVs. At 90th percentile, the performance goals were comprised between 3.2% and 13.5% for the intra-run CVs, and between 7.3% and 30.8% for the inter-run CVs. CVs calculated from 10 values were similar to those obtained from more values. Higher imprecision was observed when the antibody levels of the IQC was lower than 2 fold the positive threshold. Commercial IQCs gave lower CVs than IQCs derived from patient samples.ConclusionOur results allow proposing some acceptability limits for the precision performances of the autoantibody assays, compatible with the reality of life in diagnostic laboratories and clinical care

[Advice in autoimmunity biological diagnosis: guidelines for drafting comments on biological results].

The ISO 15189 accreditation of biological analysis requires the presence of interpretation in the analysis report. The interpretation in the field of autoimmunity which includes many analyses and methods can be complex for biologists who may not have clinical data and for clinicians who may not be aware of technical difficulties. The French group of the european group EASI (European autoimmunity standardisation initiative) proposes a list of comments and advice in order to help biologists when interpreting auto-immune analyses results in several situations. These comments should be adapted to the clinical and biological situation (other biological results, clinical data…) and should alert the clinician. A dialogue between the biologist and the clinician is essential to adjust the interpretation on clinical data in order to provide a better health care for the patient