An HPV 16, 18, and 45 genotyping test based on Hybrid Capture® technology

Human papillomavirus detection and genotyping, by HC2, full-spectrum HPV and molecular beacon real-time HPV assay in an Irish colposcopy clinic

“…At least 125 distinct HPV tests have been identified, with 84 variants of the same and for more than 75% of the HPV tests currently on the market, there is no single reference publication in the peer-reviewed literature (Poljak et al, 2012). The most commonly used commercially available HPV DNA tests include Hybrid Capture 2 for high-risk HPV (HC2), (Qiagen, Hilden, Germany), (Giorgi-Rossi et al, 2011), HC2 for detection of HPV 16, HPV 18 and HPV 45 (Qiagen, Hilden, Germany), (Thai et al, 2009), the Cervista™ HR HPV test (Hologic, Bedford, MA, USA), (Youens et al, 2011), the Cervista™ HPV 16, HPV 18 test (Hologic, Bedford, MA, USA), (Einstein et al, 2011), the Cobas 4800 HPV test (Roche Diagnostics, Mannheim, Germany), (Stoler et al, 2011), Papillocheck (Greiner Bio-One, Frickenhausen, Germany), (Dalstein et al, 2009), the Full-Spectrum HPV Amplification and Detection System (GenoID, Budapest, Hungary), (Jeney et al, 2007), GenoID Real-Time HPV Assay (GenoID, Budapest, Hungary), (Takacs et al, 2008) and the Linear Array HPV Genotyping Test (Roche Diagnostics, Mannheim, Germany), (Dobec et al, 2011), to name but a few. The HC2 test and the Cervista test received FDA approval in 2003 and 2009 respectively, for triage of women with equivocal cytology graded as Atypical Squamous Cells of Undetermined Significance and for use in women 30+ years of age in addition to routine cytology screening.…”

Visual Detection of High-Risk Human Papillomavirus Genotypes 16, 18, 45, 52, and 58 by Loop-Mediated Isothermal Amplification with Hydroxynaphthol Blue Dye

“…HPV16 is by far the predominant type, causing more than 50% of cancers; HPV18 follows, causing 14%; and HPV45 causes approximately 2.8%. These genotypes are highly prevalent in all regions of the world and account for approximately 70% of all cancers of the cervix (2,13,25). HPV types 52 and 58 are rare in Western countries; however, they are prevalent in Asian populations, especially in China (5,14,15,28,29).…”

“…The Linear Array HPV genotyping test allows for the discrimination of 37 HPV genotypes. The PapilloCheck HPV screening test (Greiner Bio-One GmbH, Frickenhausen, Germany) is a PCR-based DNA microarray system for the detection and identification of 24 HPV genotypes (4,7,13,25). However, these methods might not be suitable in primary clinical settings in developing countries or for field use, because of the sophisticated instrumentation required, elaborate and complicated assay procedures, and expensive reagents.…”

Commercially available assays for multiplex detection of alpha human papillomaviruses

“…Although the proposed novel HPV-16/18/45 genotyping test still uses hc2 technology, the long transcribed RNA probes have been replaced with a mixture of approximately 150 unique oligoribonucleotides of 25 bases in length in each probe mix. A prototype of the novel HPV-16/18/45 genotyping assay showed no cross-reactivity from any tested nontargeted hr-HPV or lr-HPV types at a concentration of 10 8 per assay [80]. Even homologous type HPV-18 and HPV-45 when tested with the assay did not show cross-reactivity against each other at 10 7 copies per assay and only minimal cross-reactivity at 10 8 copies per assay.…”

“…In parallel with the development of the next-generation hc2 assay, the manufacturer has recently significantly re-engineered PST in order to significantly improve analytical specificity and allow separate detection of three targeted HPV types, but maintaining the established hc2 clinically validated sensitivity (1 pg/ml or 5000 copies per assay) in the new product [80]. Although the proposed novel HPV-16/18/45 genotyping test still uses hc2 technology, the long transcribed RNA probes have been replaced with a mixture of approximately 150 unique oligoribonucleotides of 25 bases in length in each probe mix.…”