TY - JOUR
T1 - How to report the antinuclear antibodies (anti-cell antibodies) test on HEp-2 cells: guidelines from the ICAP initiative
AU - von Muhlen, C.A.
AU - Garcia-De La Torre, I.
AU - Infantino, M.
AU - Damoiseaux, J.
AU - Andrade, L.E.C.
AU - Carballo, O.G.
AU - Conrad, K.
AU - Francescantonio, P.L.C.
AU - Fritzler, M.J.
AU - Herold, M.
AU - Klotz, W.
AU - Cruvinel, W.D.
AU - Mimori, T.
AU - Satoh, M.
AU - Musset, L.
AU - Chan, E.K.L.
N1 - Funding Information:
The authors wish to express their gratitude to all persons who collaborated with examples of ANA Test Reports and/or with comments regarding ANA reporting in their respective laboratories and countries.
Publisher Copyright:
© 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
PY - 2021/12
Y1 - 2021/12
N2 - Results of the anti-nuclear antibodies-indirect immunofluorescence assay (anti-cell antibodies test) on HEp-2 cell substrates should be communicated to clinicians in a standardized way, adding value to laboratory findings and helping with critical clinical decisions. This paper proposes a test report based on the practices informed by 118 laboratories in 68 countries, with recommendations from the International Consensus on ANA Patterns (ICAP) group. Major focus is placed on the report format containing endpoint titers, immunofluorescence patterns together with anti-cell (AC) nomenclature, remarks on follow-up or reflex testing, and possible other autoantibody associations. ISO 15,189 directives were integrated into the test report. Special situations addressed include serum screening dilutions and endpoint titers, relevance of immunofluorescence patterns with special attention to cytoplasmic patterns, mixed and compound patterns, and how to report different titers corresponding to multiple patterns or autoantibodies in the same sample. This paper suggests a subtitle for the HEp-2-IIFA, namely anti-cell antibodies test, which could gradually substitute the original outdated ANA nomenclature. This ICAP pro forma report represents a further step in harmonizing the way relevant clinical information could be provided by laboratories.
AB - Results of the anti-nuclear antibodies-indirect immunofluorescence assay (anti-cell antibodies test) on HEp-2 cell substrates should be communicated to clinicians in a standardized way, adding value to laboratory findings and helping with critical clinical decisions. This paper proposes a test report based on the practices informed by 118 laboratories in 68 countries, with recommendations from the International Consensus on ANA Patterns (ICAP) group. Major focus is placed on the report format containing endpoint titers, immunofluorescence patterns together with anti-cell (AC) nomenclature, remarks on follow-up or reflex testing, and possible other autoantibody associations. ISO 15,189 directives were integrated into the test report. Special situations addressed include serum screening dilutions and endpoint titers, relevance of immunofluorescence patterns with special attention to cytoplasmic patterns, mixed and compound patterns, and how to report different titers corresponding to multiple patterns or autoantibodies in the same sample. This paper suggests a subtitle for the HEp-2-IIFA, namely anti-cell antibodies test, which could gradually substitute the original outdated ANA nomenclature. This ICAP pro forma report represents a further step in harmonizing the way relevant clinical information could be provided by laboratories.
KW - ANA patterns
KW - ANA test report
KW - Anti-cell antibodies test
KW - International Consensus on ANA Patterns
KW - HEp-2 cell indirect immunofluorescence assay (HEp-2 IIFA)
KW - Report of ANA test
KW - INDIRECT IMMUNOFLUORESCENCE
KW - INTERNATIONAL CONSENSUS
KW - ANTI-DFS70 ANTIBODIES
KW - PEGYLATED INTERFERON
KW - HEALTHY-INDIVIDUALS
KW - AUTOANTIBODIES
KW - PATTERN
KW - ANA
KW - DIAGNOSIS
KW - STANDARDIZATION
U2 - 10.1007/s12026-021-09233-0
DO - 10.1007/s12026-021-09233-0
M3 - Article
C2 - 34625914
SN - 0257-277X
VL - 69
SP - 594
EP - 608
JO - Immunologic Research
JF - Immunologic Research
IS - 6
ER -