This page has been archived and is no longer updated. We apologize for the inconvenience. To find similar material or an updated version of the page, please visit one the following resources:
Health Topics || Country Sites || News Releases || Our New Homepage

Esta página ha sido archivada y ya no es actualizada. Pedimos disculpas por la molestia. Para encontrar material similar o una versión actualizada de la página, visite uno de los siguientes recursos:
Temas de salud || Sitios de países || Comunicados de prensa || Nuestra nueva página de inicio

Article Index

HPV Test nameCompany nameRegulatory StatusType of AssayHPV Types Detected
Cervista HPV HR Hologic GEN-PROBE FDA approved Signal Amplification detects 14 high-risk types. (Invader method/ Fluorescence resonance energy transfer FRET) 14 high risk types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68)
Cervista HPV 16/18 Hologic GEN-PROBE FDA approved Signal Amplification detects and differentiates HPV 16 and HPV 18. (Invader method/ Fluorescence resonance energy transfer FRET) HPV 16; HPV 18
APTIMA HPV Hologic GEN-PROBE FDA-approved for ThinPrep Transcription-Mediated Amplification (TMA) of mRNA E6/E7; amplicon with Hybridization Protection Assay (HPA) 14 high risk types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68)
AMPLICOR HPV test Roche CE marked (not available in US) Target amplification. (PCR/ Multiwell Plate hybridization, enzymatic color reaction) 13 high-risk genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68)
LINEAR ARRAY HPV Genotyping Test Roche NA RUO L1 consensus PCR with Line-blot assay 37 HPV genotypes. Individual types
Cobas HPV test Roche

FDA approved CE marked

Target amplification. Simultaneous detection of 14 high-risk types + specific genotyping information for types 16 and 18. PCR/ The detection of the amplicon is performed during thermal cycling using oligonucleotide probes labeled with four different fluorescent dyes

Channel 1 - HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68

Channel 2 - HPV 16 Channel 3 - HPV 18

Xpert HPV Cepheid CE marked E6/E7 target amplification multiplex PCR 14 HR types(16,18,31,33,35,39,51,52,56,58,59,66 and 68)
BD HPV Onclarity Assay BD CE marked E6/E7 DNA target amplification, real type PCR 14 HR types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68)
Digene HC2 (Hybrid Capture 2) HPV DNA test Qiagen FDA approved Full HPV genome detection by HC2 compared to PCR targeting L1 13 HR HPV Types 16,18,31,33,35,39,45,51, 52,56,58,59 and 68
HPV genotyping RH and LX kit Qiagen   L1 consensus PCR with reverse Lineblot detection 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82
careHPV test Qiagen Application submitted for WHO prequalification Hybrid Capture 2 full-length RNA probes and signal amplification, chemiluminescence 14 HR types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68)
OncoE6 Cervical Test Arbor Vita Corporation CE marked Monoclonal antibodies in lateral-flow assay format to HPV 16/18 E6. 16, 18
Real TimeHigh-Risk HPV Abott Molecular CE marked PCR 14 HR types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68)
INNO-LiPA HPV Genotyping Extra* Innogenetics RUO SPF Target amplification. Reverse hybridization line probe assay 6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 66, 68, 69, 70, 71, 73, 74, 82
HPV DIRECT FLOW CHIP + E-BRID system Master Diagnostic (TaKaRa Shuzo Co. Ltd.)   reverse dot blot hybridization HPV6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 and 82
PapilloCheck HPV-Screening Greiner Bio-One CE marked PCR, amplicon hybridization on slide for type-specific detection 24 HPV types (6, 11, 16, 18, 31, 33, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 56, 58, 59, 66, 68, 70, 73, 82
PapilloCheck High-risk Greiner Bio-One CE marked PCR, amplicon hybridization on slide for type-specific detection 14 HR types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68)
HPV4A ACE Screening kit Seegene CE marked PCR, Gel Electrophoresis HPV 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82
Anyplex II HPV28 Seegene CE marked multiplex real-time PCR with proprietary detection system Hr: 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 69, 73, 82 Lr: 6, 11, 40, 42, 43, 44, 54, 61, 70
Multimetrix Multiplex HPV Genotyping Kit MIKROGEN (Germany) also Progen/Multimetrix   Gp5+/6+ consensus PCR, Luminex HPV 6, 11, 16, 18, 26, 31, 33, 35, 39, 42, 43, 44, 45, 51, 52, 53, 56, 58, 59, 66, 68, 70, 73, 82
CLART HPV 2 Genomica (Spain) CE marked mulit-plex PCR with visualization in low density arrays

35 low risk and high risk types

(6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 62, 66, 68, 70, 71, 72, 73, 81, 83, 84, 85, 89)

GenoFlow HPV Array DiagCor (Hong Kong)   PCR, flow-through hybridization (cassette) 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66/68,73, 82 6, 11, 40/61, 42, 43/44, 54/55, 70, 57/71, 72, 81, 84/26 plus universal HPV
fHPV Typing molGENTIX (Spain) CE marked 15 low risk and high risk types HPV 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68
Trovagene Urine-based HPV test Trovagene & Strand Life Sciences (India)--kit under development, test currently performed by Trovagene laboratory   PCR HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68
13 High-risk HPV Real-Time PCR kit Hybribio   multiplex real-time PCR 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68
PreTect HPV-Proofer NorChip AS   Multi-plex NASBA for HPV E6/E7 mRNA HPV 16/18/31/33/45
CERVIMAX IHC/WB/FC/IC VALDOSPAN GmbH   Antibodies E7 specialized kits for IHC, WB, FC, IF applications
NucliSENS easyQ Biomerieux CE-IVD NASBA amplification, real-time detection with molecular beacon probe 16, 18, 31, 33, 45
PapType Genera Biosystems   PCR with labeled nucleotides on micro beads 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68