The diagnosis of a drug hypersensitivity reaction (DHR) is complex. The first step after taking the clinical history is to look for a sensitization to confirm or exclude the diagnosis and to identify the culprit drug. Skin tests are the primary means of detecting sensitization in DHR, but are associated with a risk for a severe reaction and may be contraindicated. In vitro tests offer the potential to support or confirm a diagnosis of DHR and influence medical decision making. For immediate-type DHR, a few validated assays for measurement of specific IgE (sIgE) are commercially available to a limited number of drugs. In addition, several home-made sIgE radioimmunoassays have been used in other studies. The sensitivity of the sIgE assay is drug-dependant and generally low (0–85%) for betalactams and reported heterogeneous for other drugs ranging from 26% for chlorhexidine and 44% for suxamethonium to 92% for chlorhexidine. However, as all these studies included patients, in whom DHR was confirmed only by skin tests and not by provocation, the results have to be interpreted carefully and may be unreliable. Determination of mediators during an acute phase of a reaction may indirectly support the diagnosis of a DHR by demonstrating mast cell and basophil mediator release. Negative in vitro tests do not exclude a DHR or imputability of a drug, but a positive result may support causality and eliminate the necessity for a drug provocation test. Unfortunately, evidence is limited with a lack of well-controlled studies in larger numbers of well-phenotyped patients, which results in susceptibility for bias and a need for future multicenter studies.

药物超敏反应 (DHR) 的诊断很复杂。获取临床病史后的第一步是寻找致敏物以确认或排除诊断并确定罪魁祸首。皮肤试验是检测 DHR 致敏性的主要方法，但与发生严重反应的风险相关，可能是禁忌的。体外测试提供了支持或确认 DHR 诊断和影响医疗决策的潜力。对于即刻型 DHR，一些用于测量特定 IgE (sIgE) 的经过验证的测定法可用于有限数量的药物。此外，一些自制的 sIgE 放射免疫测定已用于其他研究。sIgE 检测的灵敏度依赖于药物，对于 β 内酰胺类药物通常较低（0-85%），据报道其他药物的异质性范围从 26% 的氯己定和 44% 的琥珀胆碱到 92% 的氯己定。然而，由于所有这些研究都包括患者，他们的 DHR 仅通过皮肤测试而不是通过刺激得到证实，因此必须仔细解释结果并且可能不可靠。在反应的急性期确定介质可以通过证明肥大细胞和嗜碱性粒细胞介质释放间接支持 DHR 的诊断。阴性体外试验不排除药物的 DHR 或可归因性，但阳性结果可能支持因果关系并消除药物激发试验的必要性。很遗憾，