Analytical validation of the basophil activation test
Analytical validation determines the accuracy of the testing procedure from the draw of the blood sample to the reporting of the results. There are several important components of the analytical validation of a basophil activation test90:
It is important to note that regulations and reimbursement/coverage by healthcare systems vary for flow cytometry based assays in different parts of the world. In the United States, BAT is used as a diagnostic test as a part of clinical decision making in allergy practices that has the capabilities of a high-complexity flow cytometry laboratory93-95. At the time of this review there are such set-ups in private clinical practice as well as academic institutions. In Europe, the BAT is mostly used in research and has been adopted as a clinical test in some countries, such as Sweden, Spain, Germany and Italy. Basophil testing has gained acceptance throughout the world, including South Africa, Eastern Europe and South America. Many allergy clinics use in house procedures (also referred to as “Laboratory Developed Tests”) detecting CD63, others use kits that are commercially available.