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Published in: Autoimmunity Highlights 2/2012

01-08-2012 | Review Article

Missing links in high quality diagnostics of inflammatory systemic rheumatic diseases

It is all about the patient!

Authors: Allan S. Wiik, Nicola Bizzaro

Published in: Autoimmunity Highlights | Issue 2/2012

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Abstract

The aim of this review is to focus attention on high quality diagnostics of systemic inflammatory rheumatic diseases. Though many steps in the diagnostic process from the first visit in a doctor’s office till a final diagnosis have been established a lot of things still must be done to improve quality assurance and secure fast and safe transmission of data from one step to the next. Some procedures inherent in early high quality diagnostics need to be worked out. A number of elements can be improved, some stumble stones can be removed, and a tighter collaboration between actors at different levels in the line of action in clinical and laboratory medicine can be organized. Several proposals have been made by international working groups such as the IUIS International Autoantibody Standardization Committee, and the EASI steering group in collaboration with their national EASI teams. Practical exercises carried out for more than three decades by the European Consensus Finding Study Group have proven to very useful. The review points at several principles worked out by these international expert groups can be useful in actual daily practice also in rheumatology. The hope is that the presentation will give rise to a continued discussion on how to link different parts of the diagnostic process together and strengthen collaboration between all teams involved in the diagnostic chain. The ultimate measure of success will be better clinical outcomes for patients and increased satisfaction in their families.
Literature
1.
go back to reference Humbel RL (1993) Detection of antinuclear antibodies by immunofluorescence, part 1. In: Maini RN, van Venrooij WJ (eds) Manual of biological markers of disease, section A2. Kluwer, Dordrecht, pp 1–16 Humbel RL (1993) Detection of antinuclear antibodies by immunofluorescence, part 1. In: Maini RN, van Venrooij WJ (eds) Manual of biological markers of disease, section A2. Kluwer, Dordrecht, pp 1–16
2.
go back to reference Wiik A, Høier-Madsen M, Forslid J, Charles P, Meyrowitsch (2010) Antinuclear antibodies: a contemporary nomenclature using HEp-2 cells. J Autoimmun 35:276–90 Wiik A, Høier-Madsen M, Forslid J, Charles P, Meyrowitsch (2010) Antinuclear antibodies: a contemporary nomenclature using HEp-2 cells. J Autoimmun 35:276–90
3.
4.
go back to reference Shoenfeld Y, Cervera R, Gershwin ME (2008) Diagnostic criteria in autoimmune diseases. Humana Press, TotowaCrossRef Shoenfeld Y, Cervera R, Gershwin ME (2008) Diagnostic criteria in autoimmune diseases. Humana Press, TotowaCrossRef
5.
go back to reference Wiik AS, Gordon TP, Kavanaugh AF, Lahita RG, Reeves W, van Venrooij WJ, Wilson MR, Fritzler M, The IUIS/WHO/AF/CDC Committee for the Standardization of Autoantibodies in Rheumatic and Related Diseases (2004) Cutting edge diagnostics in rheumatology: the role of patients, clinicians, and laboratory scientists in optimizing the use of autoimmune serology. Arthritis Rheum (Arthritis Care Res) 51:291–298CrossRef Wiik AS, Gordon TP, Kavanaugh AF, Lahita RG, Reeves W, van Venrooij WJ, Wilson MR, Fritzler M, The IUIS/WHO/AF/CDC Committee for the Standardization of Autoantibodies in Rheumatic and Related Diseases (2004) Cutting edge diagnostics in rheumatology: the role of patients, clinicians, and laboratory scientists in optimizing the use of autoimmune serology. Arthritis Rheum (Arthritis Care Res) 51:291–298CrossRef
6.
go back to reference Wiik AS (2005) Anti-nuclear autoantibodies: clinical utility for diagnosis, prognosis, monitoring, and planning of treatment strategy in systemic immunoinflammatory diseases. Scand J Rheumatol 34:260–268PubMedCrossRef Wiik AS (2005) Anti-nuclear autoantibodies: clinical utility for diagnosis, prognosis, monitoring, and planning of treatment strategy in systemic immunoinflammatory diseases. Scand J Rheumatol 34:260–268PubMedCrossRef
7.
go back to reference Fries JF (1984) The chronic disease data bank: first principles to future directions. J Med Philos 9:161–180PubMedCrossRef Fries JF (1984) The chronic disease data bank: first principles to future directions. J Med Philos 9:161–180PubMedCrossRef
8.
go back to reference Wiik AS, Fritzler MJ (2008) Laboratory tests in rheumatic disorders. In: Hochberg MC, Silman AJ, Smolen JS, Weinblatt ME, Weisman MH (eds) Rheumatology, 4th edn. Mosby Elsevier, Edinburg, pp 219–232 Wiik AS, Fritzler MJ (2008) Laboratory tests in rheumatic disorders. In: Hochberg MC, Silman AJ, Smolen JS, Weinblatt ME, Weisman MH (eds) Rheumatology, 4th edn. Mosby Elsevier, Edinburg, pp 219–232
9.
go back to reference Wiik A, Cervera R, Haass M, Kallenberg C, Khamashta M, Meroni PL et al (2006) European attempts to set guidelines for improving diagnostics of autoimmune rheumatic disorders. Lupus 15:391–396PubMedCrossRef Wiik A, Cervera R, Haass M, Kallenberg C, Khamashta M, Meroni PL et al (2006) European attempts to set guidelines for improving diagnostics of autoimmune rheumatic disorders. Lupus 15:391–396PubMedCrossRef
10.
go back to reference Tozzoli R, Bizzaro N (2012) The clinical autoimmunologist and the laboratory autoimmunologist: the two sides of the coin. Autoimmun Rev. Epub ahead of print Tozzoli R, Bizzaro N (2012) The clinical autoimmunologist and the laboratory autoimmunologist: the two sides of the coin. Autoimmun Rev. Epub ahead of print
11.
go back to reference Bossuyt X, Louche C, Wiik A (2008) Standardisation in clinical laboratory medicine: an ethical reflection. Ann Rheum Dis 67:1061–1063PubMedCrossRef Bossuyt X, Louche C, Wiik A (2008) Standardisation in clinical laboratory medicine: an ethical reflection. Ann Rheum Dis 67:1061–1063PubMedCrossRef
12.
go back to reference Chan EKL, Fritzler MJ, Wiik A, Andrade LEC, Reeves WH, Tincani A, Meroni PL, The IUIS/WHO/AF/CDC Committee for the Standardization of Autoantibodies in Rheumatic and Related Diseases (2006) AutoABSC.Org—Autoantibody Standardization Committee in 2006. Autoimmun Rev 6:577–580CrossRef Chan EKL, Fritzler MJ, Wiik A, Andrade LEC, Reeves WH, Tincani A, Meroni PL, The IUIS/WHO/AF/CDC Committee for the Standardization of Autoantibodies in Rheumatic and Related Diseases (2006) AutoABSC.Org—Autoantibody Standardization Committee in 2006. Autoimmun Rev 6:577–580CrossRef
13.
go back to reference Shoenfeld Y, Cervera R, Haass M, Kallenberg C, Khamashta M, Meroni PL, Piette J-C, Schmidt R, Wiik A (2007) EASI—The European Autoimmunity Standardisation Initiative: a new initiative that can contribute to agreed diagnostic models of diagnosing autoimmune disorders throughout. Ann N Y Acad Sci 1109:138–144PubMedCrossRef Shoenfeld Y, Cervera R, Haass M, Kallenberg C, Khamashta M, Meroni PL, Piette J-C, Schmidt R, Wiik A (2007) EASI—The European Autoimmunity Standardisation Initiative: a new initiative that can contribute to agreed diagnostic models of diagnosing autoimmune disorders throughout. Ann N Y Acad Sci 1109:138–144PubMedCrossRef
14.
go back to reference van Venrooij WJ, Charles P, Maini RN (1991) The consensus workshops for the detection of autoantibodies to intracellular antigens in rheumatic diseases. J Immunol Methods 140:181–189PubMedCrossRef van Venrooij WJ, Charles P, Maini RN (1991) The consensus workshops for the detection of autoantibodies to intracellular antigens in rheumatic diseases. J Immunol Methods 140:181–189PubMedCrossRef
15.
go back to reference Meroni PL, Schur PH (2010) ANA screening: an old test with new recommendations. Ann Rheum Dis 69:1420–1422PubMedCrossRef Meroni PL, Schur PH (2010) ANA screening: an old test with new recommendations. Ann Rheum Dis 69:1420–1422PubMedCrossRef
16.
go back to reference Kavanaugh A (2001) The utility of immunologic laboratory tests in patients with rheumatic diseases. Arthritis Rheum 44:2221–2223PubMedCrossRef Kavanaugh A (2001) The utility of immunologic laboratory tests in patients with rheumatic diseases. Arthritis Rheum 44:2221–2223PubMedCrossRef
17.
go back to reference Fritzler MJ (2010) The antinuclear antibody test: last or lasting gasp? Arthritis Rheum 63:19–22CrossRef Fritzler MJ (2010) The antinuclear antibody test: last or lasting gasp? Arthritis Rheum 63:19–22CrossRef
18.
go back to reference Bizzaro N, Wiik A (2004) Appropriateness in antinuclear antibody testing: from clinical request to strategic laboratory practice. Clin Exp Rheumatol 22:349–355PubMed Bizzaro N, Wiik A (2004) Appropriateness in antinuclear antibody testing: from clinical request to strategic laboratory practice. Clin Exp Rheumatol 22:349–355PubMed
19.
go back to reference Arbuckle MR, McClain MT, Rubertone MV, Scofield RH, Dennis GJ, James J et al (2003) Development of auto-antibodies before the clinical onset of systemic lupus erythematosus. New Engl J Med 349:1526–1533PubMedCrossRef Arbuckle MR, McClain MT, Rubertone MV, Scofield RH, Dennis GJ, James J et al (2003) Development of auto-antibodies before the clinical onset of systemic lupus erythematosus. New Engl J Med 349:1526–1533PubMedCrossRef
20.
go back to reference Mariz HA, Sato EI, Barbosa SH, Rodrigues SH, Dellavance A, Andrade LEC (2011) Pattern on the antinuclear antibody HEp-2 test is a critical parameter for discriminating antinuclear antibody-positive healthy individuals and patients with autoimmune rheumatic diseases. Arthritis Rheum 63:191–200PubMedCrossRef Mariz HA, Sato EI, Barbosa SH, Rodrigues SH, Dellavance A, Andrade LEC (2011) Pattern on the antinuclear antibody HEp-2 test is a critical parameter for discriminating antinuclear antibody-positive healthy individuals and patients with autoimmune rheumatic diseases. Arthritis Rheum 63:191–200PubMedCrossRef
21.
go back to reference Wiik A, Lam K (2000) On the usability of extended DOORS for education and training, quality assurance and consensus formation. The EU CANTOR project HC 4003 (HC). Deliverable D09.1, version 2.1. The European Commission; 2001 Wiik A, Lam K (2000) On the usability of extended DOORS for education and training, quality assurance and consensus formation. The EU CANTOR project HC 4003 (HC). Deliverable D09.1, version 2.1. The European Commission; 2001
22.
go back to reference Wiik A, Charles P, Meyrowitsch J (2011) Multi-centre collaboration is needed to reach a unified and strictly defined classification of IIF HEp-2 cell staining patterns. In: Conrad K, Chan EKL, Meroni PL, Shoenfeld Y (eds) Autoantigens, autoantibodies, autoimmunity, vol 7. Pabst, Lengerich, pp 634–646 Wiik A, Charles P, Meyrowitsch J (2011) Multi-centre collaboration is needed to reach a unified and strictly defined classification of IIF HEp-2 cell staining patterns. In: Conrad K, Chan EKL, Meroni PL, Shoenfeld Y (eds) Autoantigens, autoantibodies, autoimmunity, vol 7. Pabst, Lengerich, pp 634–646
23.
go back to reference Conrad K, Schössler W, Hiepe F, Fritzler MJ (2007) Autoantibodies in systemic autoimmune diseases. A diagnostic reference, 2nd edn. Pabst, Lengerich Conrad K, Schössler W, Hiepe F, Fritzler MJ (2007) Autoantibodies in systemic autoimmune diseases. A diagnostic reference, 2nd edn. Pabst, Lengerich
24.
go back to reference Stinton LM, Eystathioy T, Selak S, Chan EK, Fritzler MJ (2004) Autoantibodies to protein transport and messenger RNA processing pathways: endosomes, lysosomes, Golgi complex, proteasomes, assemblyosomes, exosomes and GW bodies. Clin Immunol 110:30–44PubMedCrossRef Stinton LM, Eystathioy T, Selak S, Chan EK, Fritzler MJ (2004) Autoantibodies to protein transport and messenger RNA processing pathways: endosomes, lysosomes, Golgi complex, proteasomes, assemblyosomes, exosomes and GW bodies. Clin Immunol 110:30–44PubMedCrossRef
25.
go back to reference Hiemann R, Büttner T, Krieger T, Roggenbuck D, Sack U, Conrad K (2009) Challenges of automated screening and differentiation of non-organ specific autoantibodies on HEp-2 cells. Autoimmunity Rev 9:17–22CrossRef Hiemann R, Büttner T, Krieger T, Roggenbuck D, Sack U, Conrad K (2009) Challenges of automated screening and differentiation of non-organ specific autoantibodies on HEp-2 cells. Autoimmunity Rev 9:17–22CrossRef
26.
go back to reference Egerer K, Roggenbuck D, Hiemann R, Weyer MG, Büttner T, Radau B (2010) Automated evaluation of autoantibodies on human epithelial-2 cells as an approach to standardize cell-based immuno-fluorescence tests. Arthritis Res Ther 12:R40PubMedPubMedCentralCrossRef Egerer K, Roggenbuck D, Hiemann R, Weyer MG, Büttner T, Radau B (2010) Automated evaluation of autoantibodies on human epithelial-2 cells as an approach to standardize cell-based immuno-fluorescence tests. Arthritis Res Ther 12:R40PubMedPubMedCentralCrossRef
27.
go back to reference Tan EM, Feltkamp TE, Smolen JS, Butcher B, Dawkins R, Fritzler MJ et al (1997) Range of antinuclear antibodies in “healthy” individuals. Arthritis Rheum 40:1601–1611PubMedCrossRef Tan EM, Feltkamp TE, Smolen JS, Butcher B, Dawkins R, Fritzler MJ et al (1997) Range of antinuclear antibodies in “healthy” individuals. Arthritis Rheum 40:1601–1611PubMedCrossRef
28.
go back to reference Kavanaugh A, Russell T, Reveille J, Solomon DH, Homburger HA (2000) Guidelines for clinical use of the antinuclear antibody test and tests for specific autoantibodies to nuclear antigens. Arch Pathol Lab Med 124:71–81PubMed Kavanaugh A, Russell T, Reveille J, Solomon DH, Homburger HA (2000) Guidelines for clinical use of the antinuclear antibody test and tests for specific autoantibodies to nuclear antigens. Arch Pathol Lab Med 124:71–81PubMed
29.
go back to reference Fritzler MJ, Wiik A (2006) Autoantibody assays, testing, and standardization. In: Rose NR, Mackay IR (eds) The autoimmune diseases, 4th edn. Elsevier, Amsterdam, pp 1011–1022CrossRef Fritzler MJ, Wiik A (2006) Autoantibody assays, testing, and standardization. In: Rose NR, Mackay IR (eds) The autoimmune diseases, 4th edn. Elsevier, Amsterdam, pp 1011–1022CrossRef
30.
go back to reference Ghirardello A, Villalta D, Morozzi G, Galeazzi M, Gerli R et al (2011) Diagnostic accuracy of currently available anti-double-stranded DNA antibody assays. An Italian multicentre study. Clin Exp Rheumatol 29:50–56PubMed Ghirardello A, Villalta D, Morozzi G, Galeazzi M, Gerli R et al (2011) Diagnostic accuracy of currently available anti-double-stranded DNA antibody assays. An Italian multicentre study. Clin Exp Rheumatol 29:50–56PubMed
31.
go back to reference Sack U, Conrad K, Csernok E, Frank I, Hiepe GF, Krieger T, German EASI (European Autoimmunity Standardization Initiative) et al (2009) Autoantibody detection using indirect immunofluorescence on HEp-2 cells. Dtsch Med Wochenschr 134:1278–1282PubMedCrossRef Sack U, Conrad K, Csernok E, Frank I, Hiepe GF, Krieger T, German EASI (European Autoimmunity Standardization Initiative) et al (2009) Autoantibody detection using indirect immunofluorescence on HEp-2 cells. Dtsch Med Wochenschr 134:1278–1282PubMedCrossRef
32.
go back to reference Damoiseax J, Tervaert JW, Derksen R, Hamann D, Hooijkaas H, Klasen I et al (2009) Autoantibody standardization in the Netherlands. Ann N Y Acad Sci 1173:10–14CrossRef Damoiseax J, Tervaert JW, Derksen R, Hamann D, Hooijkaas H, Klasen I et al (2009) Autoantibody standardization in the Netherlands. Ann N Y Acad Sci 1173:10–14CrossRef
33.
go back to reference Cervera R, Plaza A (2009) Guias de pratica clinica y laboratorio.Anticuerpos y enfermedades autoimmune. Sweden Diagnostics, Barcelona Cervera R, Plaza A (2009) Guias de pratica clinica y laboratorio.Anticuerpos y enfermedades autoimmune. Sweden Diagnostics, Barcelona
34.
35.
go back to reference Wiik AS (2003) Appropriateness in autoantibody testing in clinical medicine. Clin Chim Acta 333:177–180PubMedCrossRef Wiik AS (2003) Appropriateness in autoantibody testing in clinical medicine. Clin Chim Acta 333:177–180PubMedCrossRef
36.
37.
go back to reference Laposata M (2004) Patient-specific narrative interpretations of complex clinical laboratory evaluations: who is competent to provide them? Clin Chem 50:471–472PubMedCrossRef Laposata M (2004) Patient-specific narrative interpretations of complex clinical laboratory evaluations: who is competent to provide them? Clin Chem 50:471–472PubMedCrossRef
38.
go back to reference Shoenfeld Y, Gershwin ME, Meroni PL (2007) Autoantibodies, 2nd edn. Elsevier, Amsterdam Shoenfeld Y, Gershwin ME, Meroni PL (2007) Autoantibodies, 2nd edn. Elsevier, Amsterdam
39.
go back to reference Satoh M, Chan JY, Ross SJ, Cerebelli A, Cavazzana I, Franceschini F et al (2011) Autoantibodies to survival of motor neuron complex in patients with polymyositis: immunoprecipitation of D, E, F and G proteins without other components of small nuclear ribonucleoproteins. Arthritis Rheum 63:1972–1978PubMedPubMedCentralCrossRef Satoh M, Chan JY, Ross SJ, Cerebelli A, Cavazzana I, Franceschini F et al (2011) Autoantibodies to survival of motor neuron complex in patients with polymyositis: immunoprecipitation of D, E, F and G proteins without other components of small nuclear ribonucleoproteins. Arthritis Rheum 63:1972–1978PubMedPubMedCentralCrossRef
40.
go back to reference Zieve G, Fury M, Janssen EJR (1993) Analysis of autoimmune sera by immuno-precipitation of cellular RNPs. In: van Venrooij WJ, Maini RN (eds) Manual of biological markers of disease, section A7. Kluwer, Dordrecht Zieve G, Fury M, Janssen EJR (1993) Analysis of autoimmune sera by immuno-precipitation of cellular RNPs. In: van Venrooij WJ, Maini RN (eds) Manual of biological markers of disease, section A7. Kluwer, Dordrecht
41.
go back to reference Kuwana M, Kaburaki J, Okano Y, Tojo T, Homma M (1994) Clinical and prognostic associations based on serum antinuclear antibodies in Japanese patients with systemic sclerosis. Arthritis Rheum 37:75–83PubMedCrossRef Kuwana M, Kaburaki J, Okano Y, Tojo T, Homma M (1994) Clinical and prognostic associations based on serum antinuclear antibodies in Japanese patients with systemic sclerosis. Arthritis Rheum 37:75–83PubMedCrossRef
42.
go back to reference Kuwana M, Kaburaki J, Mimori T, Kawakami Y, Tojo T (2000) Longitudinal analysis of autoantibody response to topoisomerase I in systemic sclerosis. Arthritis Rheum 43:1074–1084PubMedCrossRef Kuwana M, Kaburaki J, Mimori T, Kawakami Y, Tojo T (2000) Longitudinal analysis of autoantibody response to topoisomerase I in systemic sclerosis. Arthritis Rheum 43:1074–1084PubMedCrossRef
43.
go back to reference Mierau R, Moinzadeh P, Riemekasten G, Melchers I, Reichenberger F et al (2011) Frequency of disease-associated and other nuclear autoantibodies in patients of the German network for systemic scleroderma: correlation with clinical features. Arthritis Res Ther 13:R172PubMedPubMedCentralCrossRef Mierau R, Moinzadeh P, Riemekasten G, Melchers I, Reichenberger F et al (2011) Frequency of disease-associated and other nuclear autoantibodies in patients of the German network for systemic scleroderma: correlation with clinical features. Arthritis Res Ther 13:R172PubMedPubMedCentralCrossRef
44.
go back to reference Walker UA, Tyndall A, Czirja′k L, Denton C, Farge-Bancel D, Kowal-Bielecka O, Müller-Ladner U, Bocelli-Tyndall C, Matucci-Cerinic M, EUSTAR et al (2007) Clinical risk assessment of organ manifestations in systemic sclerosis: a report from the EULAR scleroderma trials and research group database. Ann Rheum Dis 66:754–763 Walker UA, Tyndall A, Czirja′k L, Denton C, Farge-Bancel D, Kowal-Bielecka O, Müller-Ladner U, Bocelli-Tyndall C, Matucci-Cerinic M, EUSTAR et al (2007) Clinical risk assessment of organ manifestations in systemic sclerosis: a report from the EULAR scleroderma trials and research group database. Ann Rheum Dis 66:754–763
45.
go back to reference Koenig M, Joyal F, Fritzler MJ, Roussin A, Abrahamowicz M, Boire G et al (2008) Autoantibodies and microvascular damage are independent predictive factors for the progression of Raynaud’s phenomenon to systemic sclerosis: a twenty-year prospective study of 568 patients, with validation of proposed criteria for early systemic sclerosis. Arthritis Rheum 58:3902–3912PubMedCrossRef Koenig M, Joyal F, Fritzler MJ, Roussin A, Abrahamowicz M, Boire G et al (2008) Autoantibodies and microvascular damage are independent predictive factors for the progression of Raynaud’s phenomenon to systemic sclerosis: a twenty-year prospective study of 568 patients, with validation of proposed criteria for early systemic sclerosis. Arthritis Rheum 58:3902–3912PubMedCrossRef
46.
go back to reference Koenig M, Fritzler MJ, Targoff IN, Troyanov Y, Sénecal J-L (2007) Heterogeneity of autoantibodies in 100 patients with autoimmune myositis: insights in clinical features and outcomes. Arthritis Res Ther 9:R78PubMedPubMedCentralCrossRef Koenig M, Fritzler MJ, Targoff IN, Troyanov Y, Sénecal J-L (2007) Heterogeneity of autoantibodies in 100 patients with autoimmune myositis: insights in clinical features and outcomes. Arthritis Res Ther 9:R78PubMedPubMedCentralCrossRef
47.
go back to reference Tan EM, Smolen JS, McDougal JS, Butcher BT, Conn D, Dawkins R et al (1999) A critical evaluation of enzyme immunoassays for detection of antinuclear antibodies of defined specificity I. Precision, sensitivity, and specificity. Arthritis Rheum 42:455–464PubMedCrossRef Tan EM, Smolen JS, McDougal JS, Butcher BT, Conn D, Dawkins R et al (1999) A critical evaluation of enzyme immunoassays for detection of antinuclear antibodies of defined specificity I. Precision, sensitivity, and specificity. Arthritis Rheum 42:455–464PubMedCrossRef
48.
go back to reference Tan EM, Smolen J, McDougal JS, Fritzler MJ, Gordon T, Hardin JA et al (2002) A critical evaluation of enzyme immunoassays for detection of antinuclear antibodies of defined specificities. II. Potential for quantitation of antibody content. J Rheumatol 29:68–74PubMed Tan EM, Smolen J, McDougal JS, Fritzler MJ, Gordon T, Hardin JA et al (2002) A critical evaluation of enzyme immunoassays for detection of antinuclear antibodies of defined specificities. II. Potential for quantitation of antibody content. J Rheumatol 29:68–74PubMed
49.
go back to reference Fritzler MJ, Wiik A, Tan EM, Smolen JS, McDougal JS, Chan EK et al (2003) A critical evaluation of enzyme immunoassay kits for detection of antinuclear antibodies of defined specificities. III. Comparative performance characteristics of academic and manufacturer’s laboratories. J Rheumatol 30:2374–2381PubMed Fritzler MJ, Wiik A, Tan EM, Smolen JS, McDougal JS, Chan EK et al (2003) A critical evaluation of enzyme immunoassay kits for detection of antinuclear antibodies of defined specificities. III. Comparative performance characteristics of academic and manufacturer’s laboratories. J Rheumatol 30:2374–2381PubMed
50.
go back to reference Van der Cruyssen B, Hoffman IE, Zmierczak H, van den Berghe M, Kruithof E, de Rycke L et al (2005) Anti-citrullinated peptide antibodies may occur in patients with psoriatic arthritis. Ann Rheum Dis 64:1145–1149CrossRef Van der Cruyssen B, Hoffman IE, Zmierczak H, van den Berghe M, Kruithof E, de Rycke L et al (2005) Anti-citrullinated peptide antibodies may occur in patients with psoriatic arthritis. Ann Rheum Dis 64:1145–1149CrossRef
52.
go back to reference van Venrooij WJ, van Beers JJ, Pruijn GJ (2011) Anti-CCP antibodies: the past, the present and the future. Nat Rev Rheumatol 7:391–398PubMedCrossRef van Venrooij WJ, van Beers JJ, Pruijn GJ (2011) Anti-CCP antibodies: the past, the present and the future. Nat Rev Rheumatol 7:391–398PubMedCrossRef
53.
go back to reference Wiik AS, van Venrooij WJ, Pruijn GJM (2010) All you wanted to know about anti-CCP but were afraid to ask. Autoimmun Rev 10:90–93PubMedCrossRef Wiik AS, van Venrooij WJ, Pruijn GJM (2010) All you wanted to know about anti-CCP but were afraid to ask. Autoimmun Rev 10:90–93PubMedCrossRef
54.
go back to reference Bizzaro N, Tonutti E, Tozzoli R, Villalta D (2007) Analytical and diagnostic characteristics of 11 2nd- and 3rd-generation immunoenzymatic methods for the detection of antibodies to citrullinated proteins. Clin Chem 53:1527–1533PubMedCrossRef Bizzaro N, Tonutti E, Tozzoli R, Villalta D (2007) Analytical and diagnostic characteristics of 11 2nd- and 3rd-generation immunoenzymatic methods for the detection of antibodies to citrullinated proteins. Clin Chem 53:1527–1533PubMedCrossRef
55.
go back to reference ISO 15189:2003. Medical laboratories: particular requirements for quality and competence. ISO, Geneva, 2003 ISO 15189:2003. Medical laboratories: particular requirements for quality and competence. ISO, Geneva, 2003
56.
go back to reference Bizzaro N, Tozzoli R, Tonutti E, Piazza A, Manoni F, Ghirardello A et al (1998) Variability between methods to determine ANA, anti-dsDNA and anti-ENA autoantibodies: a collaborative study with the biomedical industry. J Immunol Methods 219:99–107PubMedCrossRef Bizzaro N, Tozzoli R, Tonutti E, Piazza A, Manoni F, Ghirardello A et al (1998) Variability between methods to determine ANA, anti-dsDNA and anti-ENA autoantibodies: a collaborative study with the biomedical industry. J Immunol Methods 219:99–107PubMedCrossRef
57.
go back to reference Villalta D, Bizzaro N, Platzgummer S, Antico A, Tampoia M, Camogliano L et al (2005) Accuracy of semiquantitative immunoenzymatic methods in quantitation of anti-topoisomerase I (Scl-70) antibodies. Clin Rheumatol 24:453–459PubMedCrossRef Villalta D, Bizzaro N, Platzgummer S, Antico A, Tampoia M, Camogliano L et al (2005) Accuracy of semiquantitative immunoenzymatic methods in quantitation of anti-topoisomerase I (Scl-70) antibodies. Clin Rheumatol 24:453–459PubMedCrossRef
58.
go back to reference Clinical and Laboratory Standards Institute (2006) Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline, 2nd ed. CLSI document I/LA2-A2. Wayne, PA: CLSI Clinical and Laboratory Standards Institute (2006) Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline, 2nd ed. CLSI document I/LA2-A2. Wayne, PA: CLSI
59.
go back to reference Bayer PM, Bauerfeind S, Bienvenu J, Fabien N, Frei PC, Gildburd B (1999) Multicenter evaluation study on an new HEp2 ANA screening enzyme immune assay. J Autoimmun 13:89–93PubMedCrossRef Bayer PM, Bauerfeind S, Bienvenu J, Fabien N, Frei PC, Gildburd B (1999) Multicenter evaluation study on an new HEp2 ANA screening enzyme immune assay. J Autoimmun 13:89–93PubMedCrossRef
60.
go back to reference Rondell JMM, Van Gelder M, Van der Leeden H, Dinkelaar RB (1999) Different strategies in the laboratory diagnosis of autoimmune disease: immunofluorescence, enzyme-linked-immunosorbent assay or both? Ann Clin Biochem 36:189–195CrossRef Rondell JMM, Van Gelder M, Van der Leeden H, Dinkelaar RB (1999) Different strategies in the laboratory diagnosis of autoimmune disease: immunofluorescence, enzyme-linked-immunosorbent assay or both? Ann Clin Biochem 36:189–195CrossRef
61.
go back to reference Tonutti E, Bassetti D, Piazza A, Visentini D, Poletto M, Bassetto F et al (2004) Diagnostic accuracy of ELISA methods as an alternative test to indirect immunofluorescence for the detection of antinuclear antibodies. Evaluation of five commercial kits. Autoimmunity 37:171–176 Tonutti E, Bassetti D, Piazza A, Visentini D, Poletto M, Bassetto F et al (2004) Diagnostic accuracy of ELISA methods as an alternative test to indirect immunofluorescence for the detection of antinuclear antibodies. Evaluation of five commercial kits. Autoimmunity 37:171–176
62.
go back to reference Forsman RW (1996) Why is the laboratory an afterthought for managed care organizations? Clin Chem 42:813–816PubMed Forsman RW (1996) Why is the laboratory an afterthought for managed care organizations? Clin Chem 42:813–816PubMed
63.
go back to reference Tan EM (1993) International cooperative activities in the standardization of antinuclear antibodies. Manual of biological markers of disease, vol A1. Kluwer Academic Publishers, Dordrecht, pp 1–5 Tan EM (1993) International cooperative activities in the standardization of antinuclear antibodies. Manual of biological markers of disease, vol A1. Kluwer Academic Publishers, Dordrecht, pp 1–5
64.
go back to reference Smolen JS, Butcher B, Fritzler MJ, Gordon T, Hardin J, Kalden JR et al (1997) Reference sera for antibuclear antibodies. II. Further definition of antibody specificities in international antinuclear antibody reference sera by immunofluorescence and Western blotting. Arthritis Rheum 40:413–418PubMedCrossRef Smolen JS, Butcher B, Fritzler MJ, Gordon T, Hardin J, Kalden JR et al (1997) Reference sera for antibuclear antibodies. II. Further definition of antibody specificities in international antinuclear antibody reference sera by immunofluorescence and Western blotting. Arthritis Rheum 40:413–418PubMedCrossRef
65.
go back to reference Carey RN (2006) User verification of performances for precision and trueness; approved guideline. Clinical and Laboratory Standard Institute (CLSI) document EP15-A2, 2nd edn. CLSI:ISBN 1-56238-000-0, Wayne Carey RN (2006) User verification of performances for precision and trueness; approved guideline. Clinical and Laboratory Standard Institute (CLSI) document EP15-A2, 2nd edn. CLSI:ISBN 1-56238-000-0, Wayne
Metadata
Title
Missing links in high quality diagnostics of inflammatory systemic rheumatic diseases
It is all about the patient!
Authors
Allan S. Wiik
Nicola Bizzaro
Publication date
01-08-2012
Publisher
Springer International Publishing
Published in
Autoimmunity Highlights / Issue 2/2012
Print ISSN: 2038-0305
Electronic ISSN: 2038-3274
DOI
https://doi.org/10.1007/s13317-012-0029-0

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