Evaluation of the manufacturer-dependent differences in specific immunoglobulin E results for indoor allergens

Wojtalewicz, Nathalie; Kabrodt, Kathrin; Goseberg, Sabine; Schellenberg, Ingo

doi:10.1016/j.anai.2018.07.016

Cited by 11 publications

(5 citation statements)

References 29 publications

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“…This pointed to a satisfyingly high degree of precision in the manual analyses. Nevertheless, the good results of the heterogenous in-house collective showed that differences in manual approaches do not have as high of an impact on the general interlaboratory comparability as INSTAND previously found for in vitro allergy diagnostic immunoassays [ 45 , 46 ].…”

Section: Discussionmentioning

confidence: 84%

RNA reference materials with defined viral RNA loads of SARS-CoV-2—A useful tool towards a better PCR assay harmonization

Vierbaum

Wojtalewicz

Grunert³

et al. 2022

PLoS ONE

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SARS-CoV-2, the cause of COVID-19, requires reliable diagnostic methods to track the circulation of this virus. Following the development of RT-qPCR methods to meet this diagnostic need in January 2020, it became clear from interlaboratory studies that the reported Ct values obtained for the different laboratories showed high variability. Despite this the Ct values were explored as a quantitative cut off to aid clinical decisions based on viral load. Consequently, there was a need to introduce standards to support estimation of SARS-CoV-2 viral load in diagnostic specimens. In a collaborative study, INSTAND established two reference materials (RMs) containing heat-inactivated SARS-CoV-2 with SARS-CoV-2 RNA loads of ~107 copies/mL (RM 1) and ~106 copies/mL (RM 2), respectively. Quantification was performed by RT-qPCR using synthetic SARS-CoV-2 RNA standards and digital PCR. Between November 2020 and February 2021, German laboratories were invited to use the two RMs to anchor their Ct values measured in routine diagnostic specimens, with the Ct values of the two RMs. A total of 305 laboratories in Germany were supplied with RM 1 and RM 2. The laboratories were requested to report their measured Ct values together with details on the PCR method they used to INSTAND. This resultant 1,109 data sets were differentiated by test system and targeted gene region. Our findings demonstrate that an indispensable prerequisite for linking Ct values to SARS-CoV-2 viral loads is that they are treated as being unique to an individual laboratory. For this reason, clinical guidance based on viral loads should not cite Ct values. The RMs described were a suitable tool to determine the specific laboratory Ct for a given viral load. Furthermore, as Ct values can also vary between runs when using the same instrument, such RMs could be used as run controls to ensure reproducibility of the quantitative measurements.

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Section: Discussionmentioning

confidence: 84%

RNA reference materials with defined viral RNA loads of SARS-CoV-2—A useful tool towards a better PCR assay harmonization

Vierbaum

Wojtalewicz

Grunert³

et al. 2022

PLoS ONE

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“…In this context, if should be noted that a certain variability between different methods (and laboratories) is expected, as was recently observed. 71,72 There are a large number of singleplexed diagnostics systems in the world, and four major ones can be identified (Table 15). Each has specific characteristics and performances.…”

Section: Singleplex Assaymentioning

confidence: 99%

IgE allergy diagnostics and other relevant tests in allergy, a World Allergy Organization position paper

Ansotegui

Melioli

Canonica

et al. 2020

World Allergy Organization Journal

328

275

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Currently, testing for immunoglobulin E (IgE) sensitization is the cornerstone of diagnostic evaluation in suspected allergic conditions. This review provides a thorough and updated critical appraisal of the most frequently used diagnostic tests, both in vivo and in vitro. It discusses skin tests, challenges, and serological and cellular in vitro tests, and provides an overview of indications, advantages and disadvantages of each in conditions such as respiratory, food, venom, drug, and occupational allergy. Skin prick testing remains the first line approach in most instances; the added value of serum specific IgE to whole allergen extracts or components, as well as the role of basophil activation tests, is evaluated. Unproven, non-validated, diagnostic tests are also discussed. Throughout the review, the reader must bear in mind the relevance of differentiating between sensitization and allergy; the latter entails not only allergic sensitization, but also clinically relevant symptoms triggered by the culprit allergen.

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“…25,26 Different laboratories performing allergy testing can report variable results for the same patient. 27 Finally, manufacturer differences in allergens can lead to variable serum reactivity, 10 and although the tests used in our study have been validated in dogs, 28,29…”

Section: Discussionmentioning

confidence: 96%

“…9 For example, manufacturer differences in the development of allergen extracts remains a challenge to standardized testing. 10 Testing methodologies differ and include quantification of IgE using FceR1a-based ELISA, polyclonal antibody testing, and enzyme immunometric methodology.…”

Section: Introductionmentioning

confidence: 99%

Serum immunoglobulin E responses to aeroallergens in cats with naturally occurring airway eosinophilia compared to unaffected control cats

Buller

Johnson

Outerbridge

et al. 2020

Veterinary Internal Medicne

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Background: Eosinophilic airway disease in cats is sometimes described as allergic in origin, but controversy exists in the documentation of allergy in cats and the utility of allergy testing for respiratory tract diseases. Objective: To examine serum immunoglobulin E (IgE) response to aeroallergens in cats with airway eosinophilia. Animals: Fifteen cats with idiopathic eosinophilic airway inflammation and 9 control cats. Methods: Prospective, case-control study. Surplus serum from cats with airway eosinophilia documented by bronchoscopic bronchoalveolar lavage was submitted for IgE measurement using ELISA polyclonal antibody methodology. Responses for regional allergens (fungal organisms, weeds, grasses, trees, mites, insects) were assessed. Results were reported as ELISA absorbance units with scores 0 to 79 considered negative, scores between 80 and 300 considered intermediate, and scores >300 considered positive. Results: Cats with airway eosinophilia had significantly more positive serum IgE responses (25/720) than did healthy controls (5/432, P = .02); however, the number of cats with positive IgE responses (5/15) did not differ from controls (1/9, P = .35). The allergen that most commonly resulted in positive serum IgE response in cats with airway eosinophilia was dust mite (n = 4) followed by 2 types of storage mites (n = 3 each). No control cat tested positive for these allergens. Conclusions and Clinical Importance: Serum IgE production against aeroallergens was found in some cats with eosinophilic airway inflammation, but the number of affected cats with positive results did not differ from controls. Further investigation in cats with eosinophilic, mixed, and neutrophilic airway disease in comparison to control cats is warranted.

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Evaluation of the manufacturer-dependent differences in specific immunoglobulin E results for indoor allergens

Abstract: Even though these results are promising, future EQAs have to be closely monitored to ensure this positive trend is not just a snapshot.

Cited by 11 publications

References 29 publications

RNA reference materials with defined viral RNA loads of SARS-CoV-2—A useful tool towards a better PCR assay harmonization

RNA reference materials with defined viral RNA loads of SARS-CoV-2—A useful tool towards a better PCR assay harmonization

IgE allergy diagnostics and other relevant tests in allergy, a World Allergy Organization position paper

Serum immunoglobulin E responses to aeroallergens in cats with naturally occurring airway eosinophilia compared to unaffected control cats

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