Table 2.
Commercially a vailable HPV tests.
| Molecular target | Type differentiation | Test name | Principle | Manufacturer |
|---|---|---|---|---|
| HPV DNA (full genome) | High-risk types as a group, not type-differentiating | Hybrid Capture 2 HPV DNA Test | Hybridization | QIAGEN, Gaithersburg |
| CareHPV Test | hybridization | QIAGEN, Gaithersburg | ||
| HPV DNA (L1 ORF) | High-risk types as a group, not type-differentiating | Amplicor HPV Test | PCR | Roche, Branchburg |
| Cervista HPV HR Test1 | Hybridization (Invader)2 | Hologic, Madison | ||
| HPV DNA (L1 ORF) | Differentiate 13 or more high-risk types | CLART | Reverse line-blot Hybridization on PCR products | Genomica, Coslada |
| INNO-LiPa HPV Genotyping | Reverse line-blot Hybridization on PCR products | Innogenetics, Gent | ||
| Linear Array HPV Genotyping Test | Reverse line-blot Hybridization on PCR products | Roche, Branchburg | ||
| Digene HPV Genotyping RH Test (RUO) | Reverse line-blot Hybridization on PCR products | Digene, Hilden | ||
| HPV DNA (E1 ORF) | Differentiate 13 or more high-risk types | Infniti HPV-HR QUAD Assay | Microarray on PCR products | Autogenomics, Carlsbad |
| PapilloCheck | Microarray on PCR products | Greiner Bio-one, Frickenhausen | ||
| HPV DNA (L1 ORF) | Limited type differentiation - HPV 16/18 | Cervista HPV Test1 CORBAS 4800 HPV Test Real Time High Risk (HR) HPV Test |
Hybridization Real-time PCR Real-time PCR |
Hologic, Madison Roche, Pleasanton Abbott, Des Plaines |
| HPV E6/E7 mRNA | 14 high-risk types as a group, not type-differentiating | APTIMA HPV Assay | TMA | GenProbe, San Diego |
| HPV E6/E7 mRNA | Limited type differentiation – HPV 16/18/31/33/45 | NucliSENS EasyQ HPV3 | NASBA | BioMerieux, Marcy-l'Étoile |
| PreTect HPV-Proofer3 | NASBA | Norchip, Klokkarstua |
NASBA = nucleic acid sequence-based amplification; TMA = transcription-mediated amplification.
Also targets E6 and E7.
The “Invader” reaction involves two simultaneous isothermal reactions. A primary reaction is based on hybridization with two sequence-specific oligos to the same target, creating a single-nucleotide overlap. The overlap together with its 5' flap will be cleaved. In the secondary reaction, the cleaved flap combines with a fuorescence resonance energy transfer (FRET) probe that generates a fuorescent signal.
As a result, each released 5' flap from the primary reaction cycles on and of the FRET probes, enabling the secondary reaction to further amplify the target-specific signal to 1–10 million-fold.
Same technology marketed under different brand names in different countries.