The present invention relates to a method for assessing the causative drugs of drug hypersensitivity reactions in a human subject, comprising the steps of: incubating the leukocytes with the culprit drugsits metabolites,quantifying the level of human granulysin in the sample to indicate the culprit drugsits metabolite as antigens for lymphocytes activation in the sample.

The present invention directs to incubating lymphocytes with a suspected drugits metabolite(s) in vitro to form a reactantthe use of oligonucleotide primers, probes,capturedetection antibodies against the granulysin which is produced by the activated lymphocytes. The sensitivity of granulysin is 77.3-81.8the specificity is 92.9-95.7.

In the past decade, severe adverse drug reactions accounted for ~70 compensation of Taiwan Drug Relief Foundation. This invention can provide a saferapid in vitro diagnostic method for identifying causalitive drug(s) especially for severe cutaneous adverse reactions. This invention could preventdecrease the incidence of the drugs hypersensitivitytoward personalized medicine.