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. Author manuscript; available in PMC: 2020 Jun 10.
Published in final edited form as: Int Forum Allergy Rhinol. 2018 Feb;8(2):108–352. doi: 10.1002/alr.22073

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);
  1. SCIT;

  2. Open control

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);
  1. SLIT tablet;

  2. Placebo

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;
  1. SCIT (n = 30);

  2. No treatment (n = 20)

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
  1. Positive skin test and sIgE to Timothy grass pollen (n = 26);

  2. Positive NPT (n = 13);

  3. Negative NPT (n = 13);

  4. Nonsensitized healthy controls (n = 10)

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.
  1. Birch-positive, HDM-negative (n = 15);

  2. Birch-negative, HDM-positive (n = 15)

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
  1. SAR patients (n = 18);

  2. Controls (n = 11)

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
  1. AR patients (n = 12);

  2. LAR patients (n = 12);

  3. Controls (n = 12);

Tested to olive tree pollen
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
  1. LAR patients (n = 16);

  2. AR patients (n = 14);

  3. NAR patients (n = 10);

  4. Controls (n = 14);

Tested to D. pteronyssinus
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
  1. SAR to grass pollen (n = 31);

  2. Healthy non-atopic controls (n = 9)

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
  1. Patients sensitized to Timothy grass (n = 14);

  2. Patients sensitized to birch (n = 19);

Treated with conventional or ultra-rush AIT.
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
  1. Cat-allergic patients (n = 20);

  2. Controls (n = 19)

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
  1. AR or asthma patients sensitized to HDM (n = 53);

  2. AR or asthma patients sensitized to grass (n = 51);

  3. Atopic, non-allergic patients (n = 24);

  4. Healthy controls (n = 38)

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
  1. SAR to Timothy grass (n = 27) by clinical history, positive SPT, and sIgE;

  2. Patients receiving anti-IgE for 4 years (n = 7)

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.