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Background and aims: to assess the sensitivity and specificity for the basophil activation test (BAT) and the detection of drug-specific antibodies (IgE) in the retrospective diagnosis of β-lactam allergy by using assay- specific thresholds as resulted from the performance of receiver operating characteristics curve (ROC) analysis and to describe a sequential algorithm that might increase diagnostic sensitivity and reduce the number of patients that should undergo drug challenge tests by the joint use of in vivo and in vitro diagnostic tests. Methods: 37 patients with suspected β-lactam immediate-type hypersensitivity reactions were tested for the culprit drug. 31 healthy controls were similarly tested. BAT was performed with Flow2Cast technique (Bühlmann Laboratories, Switzerland). Drug-specific IgE antibodies were detected using “sandwich”-type radio-immunoassay (RIA) with sepharose as solid phase (Pathologie Université „H. Poincare”, France). Results: ROC curve analysis identifies an optimal threshold>1.9 for RIA positivity, with 70.3% sensitivity and 90.3% specificity. For BAT, an optimal threshold>1.97 yields 51.4% sensitivity and 90.3% specificity. 89.18% of the patients were diagnosed by the combined use of skin tests and in vitro tests results, while 10.82% of the patients had negative tests results. Conclusions: RIA seems to have higher sensitivity than BAT (70.3% versus 51.4%) for β-lactams. The joint use of allergy diagnostic tests has 89.18% sensitivity. A combination of allergologic skin tests, detection of antibiotic- specific antibodies, followed by BAT may be suitable for investigating β-lactam hypersensitivity reactions since no diagnostic test has absolute diagnostic accuracy. Rezumat Premise şi obiective: evaluarea sensibilităţii şi specificităţii testului de activare a bazofilelor (BAT) şi a determinării anticorpilor specifici (IgE) în diagnosticul retrospectiv al hipersensibilităţii la β-lactamine folosind criterii diagnostice stabilite prin efectuarea analizei curbelor ROC (receiver operating characterisitics curve) şi prezentarea unui algoritm diagnostic cu sensibilitate maximă care să reducă numărul de pacienţi supuşi testelor de provocare. Metodă: 37 pacienţi cu hipersensibilitate de tip imediat la β-lactamine au fost testaţi in vivo şi in vitro pentru antibioticul incriminat în istoric. 31 subiecţi sănătoşi au fost testaţi similar. BAT a fost efectuat prin tehnica Flow2Cast (Bühlmann Laboratories, Switzerland). Determinarea anticorpilor IgE specifici a fost efectuată prin radio-imundozare “sandwich” (RIA) pe gel solid cu sefaroză (Pathologie Université „H. Poincare”, France). Rezultate: Analiza ROC defineşte un prag optim >1.9 pentru pozitivitatea RIA, cu sensibilitate de 70.3% şi specificitate de 90.3%. Pentru BAT, un index optim>1.97 prezintă sensibilitate de 51.4% şi specificitate de 90.3%. La 89.18% dintre pacienţi diagnosticul a fost confirmat prin utilizarea combinată a testelor cutanate şi a celor in vitro, în timp ce 10.82% dintre pacienţi au avut toate testele negative. Concluzii: RIA pare să aibă o sensibilitate superioară BAT (70.3% versus 51.4%) pentru β-lactamine. Utilizarea simultană a testelor diagnostice alergologice prezintă sensibilitate de 89.18%. Sumarea testelor cutanate cu detectarea anticorpilor specifici, urmate de BAT, este o secvenţă potrivită pentru diagnosticul reacţiilor de hipersensibilitate induse de β-lactamine, niciun test diagnostic prezentând acurateţe perfectă.

Basophil activation test versus radio-immunoassay in the diagnosis of β-lactam immediate-type hypersensitivity reactions