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

Sack, Ulrich; Bossuyt, Xavier; Andreeva, Hristina; Antal‐Szalmás, Péter; Bizzaro, Nicola; Bogdanos, Dimitrios P.; Borzova, Elena; Conrad, Karsten; Dragon-Durey, Marie-Agnès; Eriksson, Catharina; Fischer, Katarzyna; Haapala, Anna‐Maija; Heijnen, Ingmar; Herold, Manfred; Klotz, Werner; Kozmar, Ana; Kuna, Andrea Tešija; Hoyos, Marcos López; Malkov, V.; Musset, Lucile; Nagy, Eszter; Rönnelid, Johan; Shoenfeld, Yehuda; Sundic, Tatjana; Tsirogianni, Alexandra; Uibo, Raivo; Sousa, Maria José Rego de; Damoiseaux, Jan

doi:10.1186/s13317-020-00134-0

Cited by 20 publications

(14 citation statements)

References 36 publications

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“…The reliability of the test result, obviously, is essential and requires implementation of high-quality ANCA assays and continuous monitoring of assay quality by IQC and EQC. In particular demands for appropriate IQC should be further defined by organizations involved in accreditation of clinical laboratories ( 25 , 26 ). The use of assay-independent controls at 2–3 levels might become mandatory.…”

Section: Discussionmentioning

confidence: 99%

“…However, the requirements are primarily based on assays used in clinical chemistry and are ill-defined for autoantibody testing ( 25 ). Recently, a European hand-out on accreditation for laboratories involved in autoantibody testing has been formulated by the European Autoimmunity Standardization Initiative (EASI) ( 26 ). The hand-out is primarily focused on commercially available assays for clinical purposes.…”

Section: Implementation Of Anca Assays In Clinical Practicementioning

confidence: 99%

“…Besides, or possibly instead of, kit-controls, kit-independent controls, either derived commercially or home-made, should be included ( 30 ), preferentially to be used in the same dilution as patient material and by taking into account long-term stability. Replacement of the kit-control by an independent control, however, implies a modification of the assay and requires additional validation efforts according to the IVD-R ( 20 , 26 ). In addition, distinct controls for multiple ANCA levels will enable to identify errors in different areas of the measuring range.…”

Section: Quality Controlmentioning

confidence: 99%

“…There exist multiple (inter)national organizations that facilitate EQC or proficiency testing. In some countries, there is a difference between EQC, which is performed on a voluntary basis, and proficiency testing, which is obligatory and involves restrictive measures ( 26 ). Participation in EQC, however, is mandatory for all parameters that are within the scope of ISO 15189 accreditation ( 20 ).…”

Section: Quality Controlmentioning

confidence: 99%

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ANCA Testing in Clinical Practice: From Implementation to Quality Control and Harmonization

Damoiseaux

2021

Front. Immunol.

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Analyses for the presence of anti-neutrophil cytoplasmic antibodies (ANCA) are important in the diagnostic work-up of patients with small vessel vasculitis. Since current immuno-assays are predominantly designed for diagnosis of patients with ANCA-associated vasculitis (AAV), implementation in routine clinical practice, internal and external quality control, and harmonization are focused on this particular use. However, ANCA testing may also be relevant for monitoring therapy efficacy and for predicting a clinical relapse in AAV patients, and even for diagnostic purposes in other clinical situations. In the current review, the topics of implementation, quality control, and standardization vs. harmonization are discussed while taking into account the different applications of the ANCA assays in the context of AAV.

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Section: Discussionmentioning

confidence: 99%

Section: Implementation Of Anca Assays In Clinical Practicementioning

confidence: 99%

Section: Quality Controlmentioning

confidence: 99%

Section: Quality Controlmentioning

confidence: 99%

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ANCA Testing in Clinical Practice: From Implementation to Quality Control and Harmonization

Damoiseaux

2021

Front. Immunol.

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“…Furthermore, integrating FI based iQC charts into the routine ANA IIF workflow offers a solution to current shortcomings of autoimmune laboratory testing in achieving ISO 15189 accreditation and could bring this branch of autoimmunity closer to other immunometric assays and their well-established rules (64,65,(67)(68)(69). To this end, it is the responsibility of the laboratory autoimmunologist to evaluate and control all the variables that have a potential impact on the total processing of the HEp-2 IIF test (70,71).…”

Section: Quality Assessementmentioning

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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How to report the antinuclear antibodies (anti-cell antibodies) test on HEp-2 cells: guidelines from the ICAP initiative

et al. 2021

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

Cited by 20 publications

References 36 publications

ANCA Testing in Clinical Practice: From Implementation to Quality Control and Harmonization

ANCA Testing in Clinical Practice: From Implementation to Quality Control and Harmonization

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

How to report the antinuclear antibodies (anti-cell antibodies) test on HEp-2 cells: guidelines from the ICAP initiative

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