STATO ATTUALE DELLE TECNOLOGIE DIAGNOSTICHE PER LA MISURA DI AUTOANTICORPI: SOTTO IL SEGNO DELL ’ AUTOMAZIONE Renato Tozzoli Laboratorio di Patologia Clinica Dipartimento di Medicina di Laboratorio Azienda Ospedaliera ‘S. Maria degli Angeli’, Pordenone
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STATO ATTUALE DELLE TECNOLOGIE DIAGNOSTICHE PER LA MISURA DI AUTOANTICORPI: SOTTO IL SEGNO DELL’AUTOMAZIONE
Renato Tozzoli
Laboratorio di Patologia Clinica
Dipartimento di Medicina di Laboratorio
Azienda Ospedaliera ‘S. Maria degli Angeli’, Pordenone
THE EVOLUTION OF AUTOIMMUNE DIAGNOSTICS
1. The evolution of the role (diagnostic, prognostic, predictive) of circulating autoantibodies
2. The evolution of clinical immunology laboratories: from academic research to autoimmunity laboratories
3. The evolution of immunoassays for autoantibody detection: from 1st, to 2nd and 3rd generation
4. The evolution of immunology laboratory specialists
The evolution of clinical immunology laboratories: from academic research to autoimmunology laboratories
The evolution of autoimmunology labs: consolidation and healthcare economics
Nakamura RM, Bylund DJ.
Factors influencing changes in the Clinical Immunology Laboratory
Clin Chem 1994; 40: 2193-2204
The major factors that will influence future laboratory test are:
A) governmental regulations
B) healtcare economics
C) advances in technology
D) advances in development and use of therapeutic agents
Hoffmann GE.
Concepts for the third generation of laboratory systems
Clin Chim Acta 1988; 278: 203-16
The two key concepts of third generation systems are consolidation and integration….
Consolidation: Combining different analytical technologies or strategies on one instrument or on one group of connected instruments.
Integration: Linking analytical instruments of groups of instruments with pre- and post-analytical devices
The evolution of autoimmunology labs: consolidation and automation
Van Lente F.
Methodology and subspecialty consolidation
in the Clinical Laboratory
Clin Chem 1997; 43: 11-2
“ Automation of sample handling as well as of instrument loading and unloading can then be maximally effective. Consolidating these processes should challenge the inefficiences of the subspecialty approach. The ability to consolidate assays for performance by the fewest number of analytical instruments can only facilitate efficiency of laboratory operations”.
Tomar R.
Total laboratory automation and diagnostic immunology
Clin Diagn Lab Immunol 1999; 6: 293-4
“ The number of total laboratory automation (TLA) installations is growing but TLA has only begun to impact diagnostic immunology…..
The reasons that diagnostic immunology is not more automated, relate to the lack of standardized assays and interpretations, the low volume of such test relative to those in other laboratory sections, and the high risk/benefit ratio of investing in development……”
The evolution of autoimmunology Labs: trend of test requests
(500.000 inhabitants, West Friuli-Venezia Giulia)
No. of autoimmunity tests 1997 a
(%)
2001 b
(%)
2007 c
(%)
2012 d
(%)
<5.000 50.0 45.0 42.0 6.8
5.001-10.000 21.5 23.0 20.0 15.6
10.001-50.000 28.5 31.0 34.0 47,6
50.001-100.000 0 2.0 4.0 18,4
>100.000 0 0 0 11.6
a 1° Survey GdS-AI - 44 labs (Villalta, et al) b 2° Survey GdS-AI - 43 labs (Tozzoli, et al) c 3° Survey GdS-AI - 30 labs (Tampoia, et al) d 4° Survey GdS-AI-325 labs (Bizzaro,et al)
Evolution of immunoassay methods for the detection and measurement of autoantibodies
Tozzoli R, et al. Clin Chem Lab Med 2013;51:129-38
12 Lakos G, et al 2014 Webb T, et al, 2014 Mondejar R, et al. 2014 Infantino M, et al 2013 Miyara M, et al 2013 Noel N, et al.2013 Mahler M, et al. 2013 Bentow C, et al. 2013 Mahler M, et al. 2013 Mahler M, et al. 2012 Mahler M, et al. 2012 Mahler M, et al. 2012
Automated CLIA Instruments and Autoimmunity Bizzaro N, Tozzoli R, Villalta D. Autoimmune Diagnostics. CRAI 2014 (in press)
The role of automated platforms:
• increased workload in the autoimmunity lab
• higher throughput
• rapid testing and response (reduction of TAT)
• standardization of analytical processes
• complete traceability
• cost containement
Cortesy by: N. Bizzaro
Autoimmune diagnostics in 2014. New technologies have the potential to change
the way we do autoimmune testing
The progressive diffusion of multiplex methods: the autoantibody profiling
L’AUTOMAZIONE DEI METODI IMMUNOMETRICI MULTIPLEX
• La sostituzione dei metodi monoplex
• L’avvento dei metodi a tracciante ‘ecologico’
• L’automazione della procedura analitica
From monoplex to multiplex IMA Ekins RP. Clin Chem 1991-1998