The importance of EN ISO 15189 accreditation of allergen-specific IgE determination for reliable<i>in vitro</i>allergy diagnosis

Lambert, Claude; Sarrat, A.; Bienvenu, F.; Brabant, Séverine; Nicaise-Roland, Pascale; Alyanakian, Marie‐Alexandra; Apoil, P.A.; Capron, Claude; Couderc, Rémy; Evrard, Bertrand; Jaby, Délia; Hémont, Caroline; Lainé, C.; Lelong, M; Mariotte, D.; Martinet, J.; Rénier, Gilles; Sainte-Laudy, J.; Tabary, Thierry; Treiner, E.; Uring‐Lambert, B.; Vigneron, C.; Vivinus, M.; Witthuhn, F.; Vitte, J.

doi:10.1111/all.12546

Cited by 27 publications

(23 citation statements)

References 23 publications

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“…The standard laboratory procedures in 2016 are based on standardized curve controls and calibrators, internationally validated cutoffs, and external quality controls. The use of in‐house pools of local patient sera is no longer recommended . Today's IgE measurements are automated, standardized, and support interlaboratory comparison …”

Section: Why Should Immunological Criteria For Abpa Diagnosis Be Updamentioning

confidence: 99%

Aspergillus fumigatus in cystic fibrosis: An update on immune interactions and molecular diagnostics in allergic bronchopulmonary aspergillosis

Carsin

Romain

Ranque

et al. 2017

Allergy

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A wide spectrum of pathological conditions may result from the interaction of Aspergillus fumigatus and the immune system of its human host. Allergic bronchopulmonary aspergillosis is one of the most severe A. fumigatus-related diseases due to possible evolution toward pleuropulmonary fibrosis and respiratory failure. Allergic bronchopulmonary aspergillosis occurs almost exclusively in cystic fibrosis or asth- | ASPERGILLUS FUMIGATUS AND ITS INTERACTION WITH THE HUMAN HOSTThe Aspergillus genus comprises 339 species of filamentous fungi ubiquitous all over the world in human environment, for example, air, soil, cereals, fruit, plants, wet and decomposing organic matter.Airborne Aspergillus spp spores are present indoors and outdoors, with an estimated 10-1000 spores inhaled daily by each human. 4,5 A growing number of Aspergillus species are recognized as pathogenic for animals and humans; yet A. fumigatus (Figure 1) The pathophysiological continuum of A. fumigatus-host interaction is mirrored by laboratory and clinical frames of "asymptomatic"colonization, "benign" IgE sensitization to A. fumigatus, through A. fumigatus-induced cough and asthma, to aspergilloma and invasive aspergilloses. However, the first two stages lack consensus definitions. The growth of A. fumigatus in the airways, also termed "car- irreversible, calls for updating the immunological criteria have been accumulating since the turn of the century. 47,52,60 These calls are supported by novel tools with enhanced performance.We will describe hereafter the issues associated with the current ABPA immunological diagnostic criteria including total serum IgE,A. fumigatus-specific IgE, and A. fumigatus-specific IgG and precipitins against A. fumigatus.

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Section: Why Should Immunological Criteria For Abpa Diagnosis Be Updamentioning

confidence: 99%

Aspergillus fumigatus in cystic fibrosis: An update on immune interactions and molecular diagnostics in allergic bronchopulmonary aspergillosis

Carsin

Romain

Ranque

et al. 2017

Allergy

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“…Generally, the results are given without errors, but recently the studies for method repeatability at different laboratories were performed. The mean coefficient of variation for all allergens, all sIgE concentrations and all laboratories was at the level of 10 % [2].…”

Section: Discussionmentioning

confidence: 88%

“…It can be notably significant, especially in the SPT, where the planimetric measurement of the wheal diameter is limited by the precision of the ruler, and it is strongly limited by the technician experience. Allergen-specific immunoglobulin E detection and quantification have become an important step in allergy detection and is validated according to the accreditation procedure under the EN ISO 15189 standard [2]. Generally, the results are given without errors, but recently the studies for method repeatability at different laboratories were performed.…”

Section: Discussionmentioning

confidence: 99%

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Thermographic imaging as alternative method in allergy diagnosis

Rok

Rokita

Tatoń

et al. 2016

J Therm Anal Calorim

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Allergen sensitization is being diagnosed by commonly available methods in clinical practice-skin prick tests (SPTs) and specific immunoglobulin E test (sIgE). Recently, a new thermographic (TH) method for the assessment of SPT was developed, and it was demonstrated that the TH measurements of forearm temperature distribution during SPT, supported by a mathematical model, offer a new quantification method of allergen-induced skin reactions. The aim of this study is a comprehensive comparison of the TH method with SPT and sIgE techniques. The studies were performed for a group of 51 patients. The SPT and sIgE examinations were done in a routine way. For TH analyses, set of thermograms of both forearms were acquired after prick and analyzed with the use of developed software. All results were converted into categorized scale for comparison. The collected results indicate high correlation coefficients between methods equal to 0.76-0.99. Sensitivity and accuracy of TH assessment in respect of both SPT and sIgE methods is at good level (0.72-0.93). Acceptable level of specificity 0.60-0.88 was also achieved for most allergic responses. Excellent agreement between SPT and sIgE methods was observed which makes the TH assessment competitive. Due to higher precision and sensitivity of digital infrared technology, possibility of making error in diagnosis is significantly reduced. Additional advantage of the TH method relies on an estimation of the skin reactivity which allows highlighting the hypersensitivity patients and automatic correction of the diagnosis.

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“…There are multiple certification bodies in each country, but just a single accreditation body, and in many European countries there is a steady increase in clinical laboratories being accredited according to the ISO 15289 standard [20]. No data exist on how many laboratories that are performing IgEanalyses are accredited, but several investigations from France, where accreditation will become compulsory in 2016 [21] illustrate the process involved in the application of ISO 15189 for the analysis of specific IgE antibodies [22].…”

Section: Regulatory Frameworkmentioning

confidence: 99%

Quality management in IgE-based allergy diagnostics

Kleine‐Tebbe¹,

Poulsen

Hamilton

2016

LaboratoriumsMedizin

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Assays for total and allergen-specific (s) IgE are essential serological tests in the diagnostic work-up of immediate type hypersensitivity reactions and atopic diseases. Technical performance characteristics and clinical utility of IgE tests have been published in international guidelines. In the USA and in Europe, IgE tests are mainly performed by accredited medical laboratories and in Germany they are also performed by allergists carrying an OIII-limited license. Both have to perform continuously internal and external quality control measures including proficiency trials twice a year (in Germany). Due to the hetero geneity of the assay's core allergen reagents, complex extracts and more recently defined allergenic molecules, and heterologous assay calibration, the results of qualitative and quantitative sIgE tests from different diagnostic manufacturers can vary considerably. Proficiency trial results are subsequently grouped according to each assay type. Passing acceptance criteria depend on national rules and regarding quality management. Future challenges include a more valid quantification of sIgE which would allow true comparisons with the international units for total IgE, and the use of harmonized allergen reagents for the most important allergen sources, which have hampered inter-assay comparability in the past. Keywords

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The importance of EN ISO 15189 accreditation of allergen-specific IgE determination for reliablein vitroallergy diagnosis

Abstract: Allergen-specific serum immunoglobulin E determination with the fluoroimmunoenzymatic method ImmunoCAP(®) is a highly repeatable, reproducible, and accurate method which may be considered as a single analyte assay in view of the EN ISO 15189 accreditation procedure.

Cited by 27 publications

References 23 publications

Aspergillus fumigatus in cystic fibrosis: An update on immune interactions and molecular diagnostics in allergic bronchopulmonary aspergillosis

Aspergillus fumigatus in cystic fibrosis: An update on immune interactions and molecular diagnostics in allergic bronchopulmonary aspergillosis

Thermographic imaging as alternative method in allergy diagnosis

Quality management in IgE-based allergy diagnostics

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