TY - JOUR
T1 - Precision of autoantibody assays in clinical diagnostic laboratories
T2 - What is the reality?
AU - Senant, Marie
AU - Musset, Lucile
AU - Chyderiotis, Georges
AU - Guis-Cabanne, Laurence
AU - Damoiseaux, Jan
AU - Fabien, Nicole
AU - Dragon-Durey, Marie-Agnes
N1 - Funding Information:
We thank all biologists from the participating French DBL for sharing their data (in alphabetical order): Biomedical Laboratory of Hospital Ambroise Paré, Paris (Dr J Zhu), Biomedical laboratory of CH Alpes Leman, Contamine/Arve (Dr B Murienne), Laboratory of Immunology, Hospital Bichat, Paris (Dr P Nicaise), Private Biomedical Laboratory BIO7/Cerballiance, Lisses (Dr M Senant), Private Biomedical Laboratory Bioliance, Nantes (Dr S Le Quere), Private Biomedical Laboratory Biomnis-Eurofins, Ivry (Dr L Guis-Cabanne), Lyon, (Dr G Chyderiotis), Laboratory of Immunology of University hospital of Caen (Dr E Comby), Biomedical Laboratory of Hospital Metropole Savoie, Chambéry (Dr C Dumollard), Biomedical Laboratory of Hospital of Annecy (Dr S Boutruche), Biomedical Laboratory of Hospital Aulnay (Dr A Grenier), Biomedical Laboratory of Hospital Libourne (Dr C Castang, Dr A Francart), Laboratory of Immunology, Hospital Pontchaillou, Rennes (Dr I Bahon-Riedinger), Laboratory of Immunology, Hospital Cochin, Paris (Dr C Goulvestre), Biomedical Laboratory of Hospital Colmar (Dr F Mathiaux), Laboratory of Immunology, Hospital Pitie-Salpetriere, Paris (Dr P Ghillani-Dalbin), Laboratory of Immunology, University Hospital of Grenoble (Dr C Dumestre-Perard), Laboratory of Immunology, Hospital Georges Pompidou, Paris (Dr M-A Dragon-Durey), Laboratory of Immunology, University Hospital of Lille (Dr S Deleplanque, Dr S Dubucquoi), Laboratory of Immunology, University Hospital of Limoges (Dr G Olombel), Laboratory of Immunology, University Hospital of Lyon (Dr N Fabien, Dr C Lombard, Dr M Dechomet, Dr L Garnier), Laboratory of Immunology, Hospital Henri Mondor, Paris (Dr T Belmondo), Laboratory of Immunology, University Hospital of Nantes (Dr C Hemont), Laboratory of Immunology, Hospital Necker Enfants Malades, Paris (Dr M-A Alyanakian), Laboratory of Immunology, University Hospital of Poitiers (Dr F Jacomet), Laboratory of Immunology, Hospital Robert Debré, Paris (Dr V Guérin), Laboratory of Immunology, University Hospital of Reims (Dr D Giusti), Laboratory of Immunology, University Hospital of Rouen (Dr F Jouen), Private Biomedical Laboratory SCMB12, Grenoble (Dr Guerber), Laboratory of Immunology, Hospital Saint Antoine, Paris (Dr C Johannet), Biomedical Laboratory of St Denis (Dr F Oukil-Fernani), Laboratory of Immunology, University Hospital of St Etienne (Dr A Berger, Dr S Paul), Laboratory of Immunology, University Hospital of Tours (Dr L Decalonne, Dr H Wattier), Biomedical Laboratory of Villefranche/Saone (Dr C Dumont).
Publisher Copyright:
© 2020 The Canadian Society of Clinical Chemists
PY - 2020/9
Y1 - 2020/9
N2 - Background: ISO 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.Methods: As 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.Results: 414 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.Conclusion: Our 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.
AB - Background: ISO 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.Methods: As 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.Results: 414 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.Conclusion: Our 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.
KW - Autoantibody
KW - Laboratory accreditation
KW - Coefficient of variation
KW - Analytic performances
KW - Internal quality control
KW - BIOLOGICAL VARIATION
KW - CLASSIFICATION CRITERIA
KW - QUALITY-CONTROL
KW - LIMITS
U2 - 10.1016/j.clinbiochem.2020.05.019
DO - 10.1016/j.clinbiochem.2020.05.019
M3 - Article
C2 - 32505738
SN - 0009-9120
VL - 83
SP - 57
EP - 64
JO - Clinical Biochemistry
JF - Clinical Biochemistry
ER -