Information about the product
Narcolepsy is an autoimmune disorder that affects approximately between 0.02 – 0.05% of the population worldwide. Narcoleptic patients frequently have severe sleepiness.
The importance of the immune system and its potential role in the onset of narcolepsy has been the focus of research and debate for many years. It has described that more than 98% of narcoleptic patients with low cerebrospinal fluid hypocretin-1 carrying HLA-DQB1*06:02, frequently in combination with HLA DRB1*15:01.
Intended use
Genvinset® HLA Narcolepsy is a semi-automated in vitro diagnostic kit for qualitative detection of the HLA-DQB1*06:02 group of alleles in genomic DNA extracted from whole blood, associated with narcolepsy predisposition, by real-time PCR using TaqMan® probes technology.
Patients who can benefit from this determination are those referred by a specialist. The results of this test should not be the only ones on which the therapeutic decision is based and should be used as an aid in the diagnosis together with results of other markers of the disease.
The intended user of the kit is technical personnel trained to carry out the protocol and the interpretation of results described in the instructions for use.
Workflow
Results
Limitations
- Mutations or polymorphisms at annealing primer/probe sites are possible and may result in the lack of allele definition. Other technologies could be necessary to resolve the typing.
- Data and result interpretation should be revised by qualified personnel.
- This product is an auxiliary tool for the diagnosis of patients with suspected narcolepsy. Use these results in conjunction with clinical data and results of other tests performed on the patient.
