TABLE VIII.F.5.
Evidence for the use of basophil activation testing in allergic rhinitis
| Study | Year | LOE | Study design | Study groups | Clinical endpoint | Conclusion |
|---|---|---|---|---|---|---|
| Schmid et al.971 | 2014 | 1b | Open RCT | SAR to grass pollen (n = 24);
|
Clinical measures of allergy, basophil sensitivity, basophil reactivity. | Basophil sensitivity changes correspond to clinical changes in allergy symptoms in patients on SCIT. Basophil reactivity did not change. |
| Van Overtvelt et al.978 | 2011 | 1b | RCT | SAR to grass pollen (n = 89);
|
BAT using CD203c at 2 and 4 months of treatment. | BAT using CD203c did not correlate with patient response. |
| Zidarn et al.977 | 2015 | 2b | Cohort | Moderate-severe SAR to grass pollen;
|
BAT using CD63 as marker for basophil response. Evaluated after 1st pollen season, after 2nd pollen season, and 1–2 years after finishing 3–5 years of SCIT. | BAT significantly decreased with SCIT; remains decreased 1–2 years after 3–5 years of SCIT treatment. BAT is an objective measure of response to AIT and is a stable marker of allergen response over a long period. |
| Zidarn et al.976 | 2012 | 2b | Cohort |
|
CD-sens, CD63 responsiveness. Tested before and after pollen season. | CD-sens 10-fold higher in symptomatic patients. Significant difference between CD63 responsiveness in those with positive NPT vs negative NPT. CD-sens a good predictor of allergic rhinitis symptoms in those sensitized to Timothy grass pollen. |
| Lesniak et al.974 | 2016 | 3b | Case-control | Allergy patients (n = 30) diagnosed by clinical symptoms, SPT, or serum IgE.
|
BAT, basophil reactivity. | Sensitivity for basophil reactivity 83%–100%; specificity 78%–89%; PPV 75%–87%; and NPV 89%–100%. BAT may replace NPT when NPT is contraindicated. Small numbers of patients used needs to be validated in larger study. |
| Ando et al.979 | 2015 | 3b | Case-control |
|
CD203c expression on basophils when stimulated with Japanese cedar pollen. | CD203c expression has diurnal variation and should be considered when using CD203c as a marker. This was also shown in basophils derived from marrow of mice-models. |
| Campo et al.308 | 2015 | 3b | Case-control |
|
NPT, serum sIgE, BAT. | NPT positive in all AR and 10/12 LAR. Serum sIgE positive in AR, negative in LAR. BAT positive in AR and in 8/12 LAR. NPT remains the gold standard, but if unable to be done, BAT should be considered. |
| Gomez et al.318 | 2013 | 3b | Case-control |
|
BAT, nasal sIgE, NPT. | AR: BAT sensitivity 85%, specificity 93%. LAR: BAT sensitivity 50%, specificity 93%. BAT diagnosed at least 50% of cases of LAR to D. pteronyssinus and was more sensitive than detection of nasal sIgE and less time-consuming than NPTs. |
| Ozdemir et al.972 | 2011 | 3b | Case-control |
|
Discrimination of pollen allergic individuals from controls using CD203c expression as marker of allergy; cutoff values of 14%. Performed during off-season. | BAT CD203c can be used to test for grass allergens if conventional measures not available. |
| Nopp et al.969 | 2009 | 3b | Case-control |
|
CD-sens. | CD-sens decreases during early phases of treatment. No change in basophil reactivity. CD-sens good objective measure to use to assess response to AIT. |
| Ocmant et al.968 | 2007 | 3b | Case-control |
|
Tested both CD63 and CD203c expression using prescribed protocol. | 100% sensitivity for both CD63 and CD203c in cat-allergic patients. CD203 is as reliable as CD63 for diagnosis of patients with IgE-mediated allergy to cat. |
| Sanz et al.967 | 2001 | 3b | Case-control |
|
Skin tests, BAT, histamine release tests, leukotriene production. | Significant correlation between skin tests and BAT (r = 0.72, p < 0.001). Positive and significant correlation between BAT and histamine release tests (r = 0.80, p < 0.001); allergen-specific LTC4, LTD4, LTE4 production (r = 0.7, p < 0.001); and the occurrence of serum sIgE (r = 0.71, p < 0.001). BAT is a highly reliable technique in the diagnosis of allergy to inhalant allergens. BAT sensitivity = 93.3%, specificity = 98.4%, when using a cutoff point of 15% activated basophils as positive result. |
| Lesniak et al.973 | 2015 | 4 | Case series | 12 patients with AR sensitized to birch or mites | Blood sample tested 1, 4, and 24 hours after sampling compared to SPT, sIgE, and NPT. | No differences in ROC characteristics between tests. BAT can be a useful approach to determine the clinically relevant allergen in sensitized patients. |
| Nopp et al.970 | 2013 | 4 | Case series | SAR to grass pollen (n = 26) | CD-sens, nPIF. | Positive nPIF and positive CD-sens in 92%. Positive nasal symptom scores and positive CD-sens scores in 85%. Subjects tested twice: CD-sens 100% reproducible vs 78% for nasal symptom scores and 94% for nPIF. CD-sens results reproducible and correlate well with other allergen testing methods. Has potential for diagnosis and follow-up after treatment. |
| Nopp et al.975 | 2006 | 4 | Case series |
|
CD-sens, SPT, NPT, IgE antibody concentration. | CD-sens correlates significantly with SPT, NPT, and IgE antibody concentration. CD-max (reactivity) did not correlate with any sensitization measures. CD-max varies substantially between patients and does not correlate to treatment or other allergy testing measures. Using CD-sens as a quantitative measure of response to therapy or to complement other testing methods is more reliable. |
AIT = allergen immunotherapy; AR = allergic rhinitis; BAT = basophil activation test; CD-sens = EC50 for allergen concentration inverted and multiplied by 100; HDM = house dust mite; IgE = immunoglobulin E; LAR = local allergic rhinitis; LOE = level of evidence; LTC4, LTD4, LTE4 = leukotriene C4, D4, E4; nPIF = nasal peak inspiratory flow; NPT = nasal provocation test; NPV = negative predictive value; PPV = positive predictive value; RCT = randomized controlled trial; ROC = receiver operating characteristic; SAR = seasonal allergic rhinitis; SCIT = subcutaneous immunotherapy; sIgE = specific immunoglobulin E; SLIT = sublingual immunotherapy.