- Comm HLA gene typing detection series (SSP) - Accu HLA gene typing detection series (qPCR) - Gold HLA gene typing detection series(SBT) - Next HLA gene typing detection series(NGS)
Detection principle:
Design specific primers and probes based on the known gene sequence of human major histocompatibility antigen molecules. When the primer sequence can fully match the target sequence, the primers undergo polymerase chain reaction. Special nucleic acid fragments will be replicated and amplified, while the probe will bind to the target sequence and generate fluorescence through the decomposition of polymerase. Fluorescence reaction indicates the presence of a target gene sequence that matches specific primers in the sample, otherwise it is not.
Detection significance:
HLA-B * 5801 is a type of HLA-B locus, and multiple domestic and foreign studies have shown that HLA-B * 5801 is highly associated with allopurinol, a commonly used drug for treating gout and hyperuricemia, in Asian populations, especially Han populations. People with the genetic marker HLA-B * 5801 are at a much higher risk of developing blindness, Steven Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN) with a clinical mortality rate of up to 30% when taking this medication. Therefore, by detecting whether the HLA-B * 5801 allele is carried, the risk of patients using allopurinol to induce SJS/TEN can be reduced. (The US FDA and medical regulatory authorities in Japan, Taiwan, and other regions have explicitly required doctors to undergo HLA-B * 5801 genetic testing before using Allopurinol on Asian populations, and this test has been included in medical insurance coverage.)
Product features:
Specific: Based on the fluorescent probe PCR method, the specificity is higher than that of ordinary PCR and fluorescent dye PCR methods
Accuracy: Amplify using three reaction wells, each containing specific primers and probes as well as internal control primers and probes, to maximize the differentiation of HLA-B * 5801 type
Convenient: Easy to operate, no need for electrophoresis
Time saving: The detection time is short, about one hour to complete the detection
Reliable: Quality control passed, results are reliable
Anti pollution: No need for electrophoresis to prevent contamination during the electrophoresis process
Detection process:
Result interpretation:
Each sample needs to undergo three tube reactions simultaneously: MIX1, MIX2, and MIX3.
Analysis project | Internal control/Ct | MIX1 Ct | MIX2 Ct | MIX3 Ct | Result determination |
Detection wavelength | HEX | CY5 | CY5 | CY5 | |
Sample to be tested | ≤35 | >35 | / | / | B5801DNAnegative |
/ | ≤30 | ≤30 | >35 | B5801DNApositive | |
>35 | >30 | >30 | >30 | Retesting | |
≤35 | 35>Ct>30 | 35>Ct>30 | 35>Ct>30 | Retesting notes1 |
Note: "/" indicates not considering
Note 1: If the same result is still obtained, it will be judged as negative
Ordering information:
Product number | Product Name | Specifications | Medical device registration certificate number |
Pharmcogenomics™ 002 | HLA-B*5801 Typing Kits | 20T / Kit | Registration certificate number: National Machinery Registration No. 20233400486 |
Contact information:
Address: 225300, East Side, 2nd Floor, G75, Phase 4, Yaocheng, Taizhou Pharmaceutical High tech Zone, Jiangsu Province
Phone: 0523-86201335 Extension product consultation: 8010
Fax: 0523-86201325
Website: www.wehelpinc.com
Email: sales@wehlepinc.com (Product Consultation)