Harmonization of clinical interpretation of antinuclear antibody test results by solid phase assay and by indirect immunofluorescence through likelihood ratios

Bossuyt, Xavier; Claessens, Jolien; Belmondo, Thibaut; Langhe, Ellen De; Westhovens, René; Poesen, Koen; Hüe, Sophie; Blockmans, Daniel Engelbert; Fritzler, Marvin J.; Mähler, Michael; Fierz, Walter

doi:10.1016/j.autrev.2019.102386

Cited by 25 publications

(14 citation statements)

References 11 publications

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“…ANA reports should be done according to ICAP recommendations [ 16 ], at least using the nomenclature. Depending on the clinical pre-test probability, there are good arguments to report specific likelihood ratios [ 46 , 47 ] in addition to titers.…”

Section: Results Reportingmentioning

confidence: 99%

Quality and best practice in medical laboratories: specific requests for autoimmunity testing

Sack

Bossuyt

Andreeva

et al. 2020

Autoimmun Highlights

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Special conditions associated with laboratory autoimmune testing are not well compatible with recent developments in regulatory frameworks such as EN/ISO 15189 accreditation or in vitro diagnostic medical device regulation (IVD-R). In addition, international recommendations, guidelines and disease criteria are poorly defined with respect to requirements on autoantibody testing. Laboratory specialists from Austria,

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Section: Results Reportingmentioning

confidence: 99%

Quality and best practice in medical laboratories: specific requests for autoimmunity testing

Sack

Bossuyt

Andreeva

et al. 2020

Autoimmun Highlights

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“…Finally, assigning the likelihood ratio (LR) value or post-test probability of disease to the HEp-2 IIF test result represents a new reporting approach in the field of ANA testing that can facilitate the clinical interpretation of test results and, by improving the comparability of the results from different analytical methods, contribute to harmonizing autoimmune laboratory reporting (81). The CAD systems, expressing the ANA test results quantitatively as FI values make the calculation of the LR easier, especially if the relationship between pre and post-test probability is represented graphically as a function of LR (62,82).…”

Section: Discussion and Future Perspectivesmentioning

confidence: 99%

Standardization and Quality Assessment Under the Perspective of Automated Computer-Assisted HEp-2 Immunofluorescence Assay Systems

Cinquanta

Bizzaro

2021

Front. Immunol.

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The recent availability of automated computer-assisted diagnosis (CAD) systems for the reading and interpretation of the anti-nuclear antibody (ANA) test performed with the indirect immunofluorescence (IIF) method on HEp-2 cells, has improved the reproducibility of the results and initiated a process of harmonization of this test. Furthermore, CAD systems provide quantitative expression of fluorescence intensity, allowing the introduction of objective quality control procedures to the monitoring of the entire process. The calibration of the reading systems and the automated image interpretation are essential prerequisites for obtaining reproducible and harmonized IIF test results and form the basis for standardization, regardless of the computer algorithms used in the different systems. The use of automated CAD systems, facilitating control procedures, represents a step forward for the quality certification of the laboratory.

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“…For this, it would be helpful to define the pre-test probability of the clinical manifestations that warrant the request of the test. Although the concept of LR seems to be restricted to quantitative immuno-assays, it is also applicable for HEp-2 IIFA as far as fluorescence intensity values are provided [42]. Alternatively, ICAP has defined the clinical relevance of distinct HEp-2 IIFA patterns in order to support the clinician in requesting adequate follow-up tests in the context of the differential diagnosis [43].…”

Section: Harmonisationmentioning

confidence: 99%

The perspective on standardisation and harmonisation: the viewpoint of the EASI president

Damoiseaux

2020

Autoimmun Highlights

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Standardisation of immuno-assays for autoantibodies is a major challenge. Although multiple organisations participate in the generation of internationally accepted standards, adequate standardisation of assays has not yet been achieved. Harmonisation may offer an alternative approach to better align requesting, testing, reporting and interpretation of autoimmune diagnostics. The European Autoimmunity Standardisation Initiative (EASI) was founded to facilitate both standardisation as well as harmonisation of autoantibody tests, but over the years the focus has drifted away from standardisation in favour of harmonisation. In the current paper the options for harmonisation are highlighted.

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Harmonization of clinical interpretation of antinuclear antibody test results by solid phase assay and by indirect immunofluorescence through likelihood ratios

Cited by 25 publications

References 11 publications

Quality and best practice in medical laboratories: specific requests for autoimmunity testing

Quality and best practice in medical laboratories: specific requests for autoimmunity testing

Standardization and Quality Assessment Under the Perspective of Automated Computer-Assisted HEp-2 Immunofluorescence Assay Systems

The perspective on standardisation and harmonisation: the viewpoint of the EASI president

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