Validation of inducible basophil biomarkers: Time, temperature and transportation.
Theodore Kim,Jing Yu,Henry Li,Mark D. Scarupa,Richard L. Wasserman,Athena Economides,Martha V. White,Carla Ward,Atul Shah,Douglas H. Jones,Melinda Rathkopf,Kelly Frye,Ahmet Aybar,Shahrooz Shayegan,Benjamin Enav,Laura Ispas,Denise Loizou,David Fitzhugh,James M. Tracy,James Friedlander,Zachary Jacobs,Jonathan Matz,David B.K. Golden,Donald McNeil,William McCann,Christopher Copenhaver,Jeffrey M. Factor,Raavi Gupta,Oral Alpan,Matthew Plassmeyer,Søren Ulrik Sønder +30 more
TL;DR: In this paper, the authors examined if it is possible to extend this window to 1 day allowing for shipment of samples between laboratories and confirmed that the stability can be extended to samples shipped overnight to the laboratory.
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Abstract: Background The short stability window of several hours from blood collection to measuring basophil activation has limited the use of flow cytometry-based basophil activation assays in clinical settings. We examine if it is possible to extend this window to 1 day allowing for shipment of samples between laboratories. Several options exist for reporting the results including reporting all the measured values directly, calculating ratios and reporting a single value covering all measured results. Each of these options have different stability and value to the physician. Methods Whole blood samples from peanut allergic patients were stimulated with four different peanut concentrations at Day 0, Day 1, and Day 2. Samples were stored under temperature-controlled conditions. Flow cytometry was used to analyze the samples. The basophil activation and degranulation were measured as percentage of positive CD63 basophils and CD203c MFI fold change. Shipped samples were transported under ambient conditions. Results The results show that CD63 is a stable marker at Day 1. The CD203c ratio decreases significantly at Day 1. Calculating the CD63/IgE ratio proves to be more stable than CD63 alone. The most stable readouts are the semi-quantitative results and the trajectory of the dose response curve. Finally, we confirmed that the stability can be extended to samples shipped overnight to the laboratory. Conclusions It is possible to extend the stability of the basophil activation assay to 1 day for samples stored at 18-25°C as well as samples shipped under ambient conditions as long as the temperature is within the 2-37°C range.
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Citations
Innovative robust basophil activation test using a novel gating strategy reliably diagnosing allergy with full automation.
TL;DR: In this article, a novel gating strategy with three antibodies (FceRIα, CD203c, CD63) was established and compared with the published protocol (12 antibodies).
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The Basophil Activation Test for Clinical Management of Food Allergies: Recent Advances and Future Directions.
Daniela Briceno Noriega,Malgorzata Teodorowicz,Huub F. J. Savelkoul,Janneke Ruinemans-Koerts +3 more
TL;DR: The basophil activation test (BAT) is an ex vivo functional assay that measures by flow cytometry the degree of basophils degranulation after stimulation with an allergen as mentioned in this paper.
Basophil activation test in food allergy: is it ready for real-time?
Tarun Keswani,Sarita U. Patil +1 more
TL;DR: Basophil activation testing (BAT) is an effective biomarker for diagnosis and monitoring of food allergy as mentioned in this paper, however, significant limitations of BAT have prevented widespread use, and addressing these limitations will increase the future application and adoption of BAT in food allergy.
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Validation of inducible basophil biomarkers: Time, temperature and transportation.
Theodore Kim,Jing Yu,Henry Li,Mark D. Scarupa,Richard L. Wasserman,Athena Economides,Martha V. White,Carla Ward,Atul Shah,Douglas H. Jones,Melinda Rathkopf,Kelly Frye,Ahmet Aybar,Shahrooz Shayegan,Benjamin Enav,Laura Ispas,Denise Loizou,David Fitzhugh,James M. Tracy,James Friedlander,Zachary Jacobs,Jonathan Matz,David B.K. Golden,Donald McNeil,William McCann,Christopher Copenhaver,Jeffrey M. Factor,Raavi Gupta,Oral Alpan,Matthew Plassmeyer,Søren Ulrik Sønder +30 more
TL;DR: In this paper, the authors examined if it is possible to extend this window to 1 day allowing for shipment of samples between laboratories and confirmed that the stability can be extended to samples shipped overnight to the laboratory.
Towards an FDA-cleared basophil activation test
Oral Alpan,Richard L. Wasserman,Theodore Kim,Amy Liebl Darter,Atul Shah,Douglas H. Jones,Don McNeil,Henry Li,L Ispas,Melinda M. Rathkopf,Elena Perez,Dareen Siri,M. O'Connor,Matthew L. Plassmeyer,Kimberly Romito,Christina Pettibone,Sean O’Reilly,Søren Ulrik Sønder,Gerald E. Marti +18 more
TL;DR: In this article , the authors proposed Epitope mapping and basophil activation test (BAT) as a means of establishing better clinical correlations, but neither has received FDA clearance for widespread distribution.
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Hans Jürgen Hoffmann,Alexandra F. Santos,Cristobalina Mayorga,Anna Nopp,Bernadette Eberlein,Marta Ferrer,Paul Rouzaire,Didier G. Ebo,Vito Sabato,Maria L. Sanz,Tatjana Pecaric-Petkovic,Sarita U. Patil,Oliver Hausmann,Wayne G. Shreffler,Peter Korošec,Edward F. Knol +15 more
TL;DR: The nature of basophil activation as an ex vivo challenge makes it a multifaceted and promising tool for the allergist, and it ought to precede challenge testing.
Basophil activation test discriminates between allergy and tolerance in peanut-sensitized children
Alexandra F. Santos,Abdel Douiri,Abdel Douiri,Natalia Bécares,Shih-Ying Wu,Alick Stephens,Suzana Radulovic,Susan M H Chan,Susan M H Chan,Adam T. Fox,George Du Toit,Victor Turcanu,Gideon Lack +12 more
TL;DR: In this paper, the basophil activation test (BAT) was used as a diagnostic marker for peanut allergy and its performance was evaluated in relation to allergy versus tolerance to peanut and validated in an independent population (n = 65).
Sustained outcomes in oral immunotherapy for peanut allergy (POISED study): a large, randomised, double-blind, placebo-controlled, phase 2 study
R. Sharon Chinthrajah,Natasha Purington,Sandra Andorf,Andrew Long,Katherine O'Laughlin,Shu Chen Lyu,Monali Manohar,Scott D. Boyd,Robert Tibshirani,Holden T. Maecker,Marshall Plaut,Kaori Mukai,Mindy Tsai,Manisha Desai,Stephen J. Galli,Kari C. Nadeau +15 more
TL;DR: It is suggested that peanut OIT could desensitise individuals with peanut allergy to 4000 mg peanut protein but discontinuation, or even reduction to 300 mg daily, could increase the likelihood of regaining clinical reactivity to peanut.
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