Bio-Speedy® HLA-B * 57: 01 Real-Time PCR Screening Kit is based on the detection of HLA-B * 57: 01 allele by human quantitative real-time polymerase chain reaction (qPCR) targeting SNP (Single Nucleotide Polymorphism) in human samples.
The qPCR threshold cycle (Cq) value, which targets the HLA-B * 57: 01 allele, is lower than the qPCR Cq targeted to the ancestral allele, indicating HLA-B * 57: 01 positivity. In other words, if the Cq value of the reaction performed with the “Mutant Oligo Mix” is lower than the Cq value of the “Wild Oligo Mix”, the HLA-B * 57: 01 test applied to the patient sample is the resultant positive.
INTENDED USE
Bio-Speedy® HLA-B * 57: 01 Real-Time PCR Screening Kit is used to test for HLA-B * 57: 01 allele presence in humans. Patients carrying the HLA-B * 57: 01 allele are at risk of exhibiting hypersensitivity (HSR) to the “Abacavir” antiretroviral agent used to treat AIDS-mediated HIV-1 (human immunodeficiency virus) infection.
The hypersensitivity reaction seen in HLA (human leukocyte antigen) -B * 57: 01 allele may be fatal. Therefore, this drug (Abacavir) is not used in patients who are HLA-B * 57: 01 test result positive.