Evaluation of the LAMP-IDE-AI platform for the detection of the HLA-B*15:02 allele in clinical application.

The HLA-B*15:02 allele is strongly associated with adverse drug reactions induced by aromatic antiseizure medications such as carbamazepine and oxcarbazepine. Consequently, it is strongly recommended to test for the presence of the HLA-B*15:02 allele before prescribing these medications. Traditional HLA genotyping methods (e.g. polymerase chain reaction or Sanger sequencing) require laboratory environments and expert personnel, resulting in a typical report turnaround time of 1-2 weeks. In this study, we developed a rapid point-of-care test (POCT) using the LAMP-IDE-AI platform for the automatic detection of the HLA-B*15:02 allele within one hour. We evaluated the platform's performance using blood samples collected from 537 children presented with a convulsion, comparing the results obtained with the LAMP-IDE-AI platform to those from PCR tests and further verifying them with Sanger Sequencing. The LAMP-IDE-AI platform exhibited 100 % sensitivity, correctly detecting all 25 positive samples. Meanwhile it demonstrated a specificity of 99.8 %, with only one sample yielding a "False Positive" result. These findings suggest that the LAMP-IDE-AI platform could potentially serve as a rapid, automated, simple, and accurate POCT for detecting the HLA-B*15:02 allele in clinical application.