Human Papillomavirus (15 Types) Genotyping Test Kit (Multicolor Fluorescence PCR) CE-IVD, Price on request

Catalog No : ATB-200180017
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Product name Human Papillomavirus (15 Types) Genotyping Test Kit (Multicolor Fluorescence PCR) CE-IVD, Price on request
Catalog No ATB-200180017
Supplier’s Catalog No 200180017
Supplier Toneker
Source antigen Human HPV
Reactivity HPV
Cross reactivity None
Applications Qualitative RT-PCR
Molecular weight N/A
Storage -15°C to -25°C
Other names Human Papillomavirus Genotyping Test Kit 15 Types (Multicolor Fluorescence PCR)
Grade Molecular diagnostic grade
Purity N/A
Form Liquid
Reactivity life 12 months when stored properly according to instructions
Note For Professional In Vitro diagnostics
Description This product is used for in vitro qualitative detection of human papillomavirus (HPV) (including 15 genotypes, namely HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66 and 68) DNA in cervical exfoliated cells and their typing. HPV is a circular double-stranded DNA virus which mainly exists in human skin, mucous membranes and amorphous areas of female cervical epithelial cells and can infect the reproductive tract in various ways. The accurate determination of HPV depends on molecular biotechnology. There are two main HPV typing methods at present, namely hybridization and polymerase chain reaction (PCR). This product is applicable for the auxiliary diagnosis of infection with HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66 and 68. The test results shall not be used as the only index for evaluating the patient's condition which, instead, must be analyzed comprehensively in combination with the patient's clinical manifestations and other test methods. As no relevant clinical trials have been done, this product shall not be used for clinical purposes related to cervical cancer screening. [Test Principle] This product is based on multiplex fluorescent PCR technology, in which a real-time fluorescent PCR instrument is used to detect 15 types of HPV and human β-globin (HBB) genes in 4 kinds of PCR reaction mixtures with four fluorescence channels (FAM, JOE (or HEX), ROX and CY5). In HPV16/58/35/HBB-PCR reaction mixture, FAM is used for the detection of HPV16, JOE (or HEX) for HPV58, ROX for HPV35 and CY5 for HBB. In HPV18/33/ 51/66-PCR reaction mixture, FAM is used for the detection of HPV18, JOE (or HEX) for HPV33, ROX for HPV51 and CY5 for HPV66. In HPV45/59/39/56-PCR reaction mixture, FAM is used for the detection of HPV45, JOE (or HEX) for HPV59, ROX for HPV39 and CY5 for HPV56. In HPV31/52/68/53-PCR reaction mixture, FAM is used for the detection of HPV31, JOE (or HEX) for HPV52, ROX for HPV68 and CY5 for HPV53. HBB, as an internal reference, is used to monitor the sample collection, DNA extraction and PCR inhibiting factors. The PCR detection system provides anti-contamination uracil glycosylase and dUTP to exclude false positive results.