digene HPV Genotyping PS Test

用于对HC2检测为阳性的样本进行HPV基因分型检测

Features

分别检测HPV16、18和45型
针对每个基因型别的高特异性RNA探针
经临床验证的杂交捕获技术
定性检测结果
符合欧盟体外诊断98/79/EC指令

Product Details

通过CE认证的digene HPV Genotyping PS Test使用杂交捕获技术检测高危人乳头瘤病毒（HPV）16、18和45型，可在研究应用中用于检测高危型HPV阳性的样本。

Performance

digene HPV Genotyping PS Test利用成熟的二代杂交捕获技术分别检测HPV 16、18和45型，不检测低于10⁸个拷贝的其他HPV型别（参见图1. Analytical specificity of HPV 16, 18, and 45 Genotyping PS probes to high-risk HPV genotypes和Analytical specificity of HPV 16, 18, and 45 Genotyping PS probes to low-risk HPV genotypes）。

Principle

digene HPV Genotyping PS Test是使用微孔板化学发光进行信号放大的体外核酸杂交检测，可对子宫颈样本中的3种高危HPV DNA进行定性检测。digene HPV Genotyping PS Test是针对digene HC2 High-Risk HPV DNA Test检测结果为阳性的样本的辅助检测，进一步检测是否为16、18和45型。

Procedure

The digene HPV Genotyping PS Test utilizes the familiar format of Hybrid Capture 2 (HC2) chemistry, using type-specific oligoribonucleotides, antibody capture, and qualitative chemiluminescent signal detection.

The digene HPV Genotyping PS Test, performed in triplicate for each cervical specimen, genotypes for 3 high-risk types (16, 18, and 45) of HPV DNA in cervical specimens. After denaturation, specimens are hybridized with specific HPV RNA probes which target the full HPV genome. The resultant RNA:DNA hybrids are captured onto the surface of a microplate well coated with antibodies specific for RNA:DNA hybrids. In the digene HPV Genotyping PS Test, the formation of hybrids and their subsequent capture onto the surface of the microplate occur simultaneously during a single step. Immobilized hybrids then react with specific alkaline phosphotase-conjugated and are detected with a chemiluminescent substrate using the DML 2000 or DML 3000 instrument.

Applications

The digene HPV Genotyping PS Test is a reflex test intended for the qualitative detection of high-risk HPV types 16, 18, and 45 following a positive digene HC2 High-Risk HPV DNA Test result. The digene HPV Genotyping PS Test may be used for testing women in cervical cancer screening programs.