TY - JOUR
T1 - Detection of antinuclear antibodies: recommendations from EFLM, EASI and ICAP
AU - Bonroy, Carolien
AU - Vercammen, Martine
AU - Fierz, Walter
AU - Andrade, Luis E. C.
AU - Van Hoovels, Lieve
AU - Infantino, Maria
AU - Fritzler, Marvin J.
AU - Bogdanos, Dimitrios
AU - Kozmar, Ana
AU - Nespola, Benoit
AU - Broeders, Sylvia
AU - Patel, Dina
AU - Herold, Manfred
AU - Zheng, Bing
AU - Chan, Eric Y. T.
AU - Uibo, Raivo
AU - Haapala, Anna-Maija
AU - Musset, Lucile
AU - Sack, Ulrich
AU - Nagy, Gabor
AU - Sundic, Tatjana
AU - Fischer, Katarzyna
AU - de Sousa, Maria-Jose Rego
AU - Vargas, Maria Luisa
AU - Eriksson, Catharina
AU - Heijnen, Ingmar
AU - Garcia-De La Torre, Ignacio
AU - Carballo, Orlando Gabriel
AU - Satoh, Minoru
AU - Kim, Kyeong-Hee
AU - Chan, Edward K. L.
AU - Damoiseaux, Jan
AU - Lopez-Hoyos, Marcos
AU - Bossuyt, Xavier
AU - European Federation of Laboratory Medicine (EFLM)
AU - Working Group “Autoimmunity Testing”
AU - European Autoimmune Standardization Initiative (EASI)
AU - International Consensus on Antinuclear Antibody Patterns (ICAP)
PY - 2023/6/27
Y1 - 2023/6/27
N2 - Objectives: Antinuclear antibodies (ANA) are important for the diagnosis of various autoimmune diseases. ANA are usually detected by indirect immunofluorescence assay (IFA) using HEp-2 cells (HEp-2 IFA). There are many variables influencing HEp-2 IFA results, such as subjective visual reading, serum screening dilution, substrate manufacturing, microscope components and conjugate. Newer developments on ANA testing that offer novel features adopted by some clinical laboratories include automated computer-assisted diagnosis (CAD) systems and solid phase assays (SPA).Methods: A group of experts reviewed current literature and established recommendations on methodological aspects of ANA testing. This process was supported by a two round Delphi exercise. International expert groups that participated in this initiative included (i) the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group "Autoimmunity Testing"; (ii) the European Autoimmune Standardization Initiative (EASI); and (iii) the International Consensus on ANA Patterns (ICAP).Results: In total, 35 recommendations/statements related to (i) ANA testing and reporting by HEp-2 IFA; (ii) HEp-2 IFA methodological aspects including substrate/conjugate selection and the application of CAD systems; (iii) quality assurance; (iv) HEp-2 IFA validation/verification approaches and (v) SPA were formulated. Globally, 95% of all submitted scores in the final Delphi round were above 6 (moderately agree, agree or strongly agree) and 85% above 7 (agree and strongly agree), indicating strong international support for the proposed recommendations.Conclusions: These recommendations are an important step to achieve high quality ANA testing.
AB - Objectives: Antinuclear antibodies (ANA) are important for the diagnosis of various autoimmune diseases. ANA are usually detected by indirect immunofluorescence assay (IFA) using HEp-2 cells (HEp-2 IFA). There are many variables influencing HEp-2 IFA results, such as subjective visual reading, serum screening dilution, substrate manufacturing, microscope components and conjugate. Newer developments on ANA testing that offer novel features adopted by some clinical laboratories include automated computer-assisted diagnosis (CAD) systems and solid phase assays (SPA).Methods: A group of experts reviewed current literature and established recommendations on methodological aspects of ANA testing. This process was supported by a two round Delphi exercise. International expert groups that participated in this initiative included (i) the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group "Autoimmunity Testing"; (ii) the European Autoimmune Standardization Initiative (EASI); and (iii) the International Consensus on ANA Patterns (ICAP).Results: In total, 35 recommendations/statements related to (i) ANA testing and reporting by HEp-2 IFA; (ii) HEp-2 IFA methodological aspects including substrate/conjugate selection and the application of CAD systems; (iii) quality assurance; (iv) HEp-2 IFA validation/verification approaches and (v) SPA were formulated. Globally, 95% of all submitted scores in the final Delphi round were above 6 (moderately agree, agree or strongly agree) and 85% above 7 (agree and strongly agree), indicating strong international support for the proposed recommendations.Conclusions: These recommendations are an important step to achieve high quality ANA testing.
KW - antinuclear antibodies
KW - HEp-2 indirect immunofluorescence
KW - recommendations
KW - JUVENILE IDIOPATHIC ARTHRITIS
KW - SYSTEMIC-LUPUS-ERYTHEMATOSUS
KW - INTERNATIONAL AUTOIMMUNE HEPATITIS
KW - ANA PATTERNS ICAP
KW - INDIRECT IMMUNOFLUORESCENCE
KW - HEP-2 CELLS
KW - HEALTHY-INDIVIDUALS
KW - CONSENSUS STATEMENT
KW - QUALITY-CONTROL
KW - RO/SS-A
U2 - 10.1515/cclm-2023-0209
DO - 10.1515/cclm-2023-0209
M3 - Article
C2 - 36989417
SN - 1434-6621
VL - 61
SP - 1167
EP - 1198
JO - Clinical Chemistry and Laboratory Medicine
JF - Clinical Chemistry and Laboratory Medicine
IS - 7
ER -