Validation of a Rapid, Robust, Inexpensive Screening Method for Detecting the HLA-B*58:01 Allele in the Prevention of Allopurinol-Induced Severe Cutaneous Adverse Reactions.
- Author:
Dinh Van NGUYEN
1
;
Christopher VIDA
;
Hieu Chi CHU
;
Richard FULTON
;
Jamma LI
;
Suran L FERNANDO
Author Information
- Publication Type:Brief Communication
- Keywords: Allopurinol hypersensitivity; HLA-B antigens; real time polymerase chain reaction; Stevens Johnson syndrome; toxic epidermal necrolysis; drug reactions with eosinophilia and systemic symptoms; severe cutaneous adverse reactions
- MeSH: Alleles*; Allopurinol; Cicatrix; DNA; HLA-B Antigens; Limit of Detection; Mass Screening*; Methods*; Real-Time Polymerase Chain Reaction; Rheumatology; Sensitivity and Specificity; Stevens-Johnson Syndrome
- From:Allergy, Asthma & Immunology Research 2017;9(1):79-84
- CountryRepublic of Korea
- Language:English
- Abstract: The HLA B*58:01 allele has been worldwide reported as a pharmacogenetic susceptibility to allopurinol-induced severe cutaneous adverse reactions (SCARs). To prevent these life-threatening conditions, the American College of Rheumatology hingly recommended that the HLA-B*58:01 be screened prior to the initiation of allopurinol therapy. Therefore, we developed a rapid, robust, inexpensive screening method using SYBR® Green real time PCR to detect the HLA-B*58:01 allele. A total of 119 samples were tested. The assay has a sensitivity of 100% (95% CI: 69.15%-100%), a specificity of 100% (95% CI: 96.67%-100%), a positive predictive value of 100% (95% CI: 69.15%-100%) and a negative predictive value of 100% (95% CI: 96.67%-100%). HLA-B*58:01 genotyping results showed 100% agreement with those obtained from Luminex SSO/SBT/SSP. The lowest limit of detection of this method is 0.8 ng/µL of DNA. The unit cost of the test is only $3.8 USD. This novel screening test using SYBR® real time PCR would be appropriate to identify individuals with the HLA-B*58:01 allele for the prevention of allopurinol-induced SCARs.
