Cervista HPV HR
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Hologic GEN-PROBE
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FDA approved
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Signal Amplification detects 14 high-risk types. (Invader method/ Fluorescence resonance energy transfer FRET)
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14 high risk types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68)
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Cervista HPV 16/18
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Hologic GEN-PROBE
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FDA approved
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Signal Amplification detects and differentiates HPV 16 and HPV 18. (Invader method/ Fluorescence resonance energy transfer FRET)
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HPV 16; HPV 18
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APTIMA HPV
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Hologic GEN-PROBE
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FDA-approved for ThinPrep
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Transcription-Mediated Amplification (TMA) of mRNA E6/E7; amplicon with Hybridization Protection Assay (HPA)
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14 high risk types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68)
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AMPLICOR HPV test
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Roche
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CE marked (not available in US)
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Target amplification. (PCR/ Multiwell Plate hybridization, enzymatic color reaction)
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13 high-risk genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68)
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LINEAR ARRAY HPV Genotyping Test
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Roche
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NA RUO
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L1 consensus PCR with Line-blot assay
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37 HPV genotypes. Individual types
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Cobas HPV test
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Roche
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FDA approved CE marked
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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
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Channel 1 - HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68
Channel 2 - HPV 16 Channel 3 - HPV 18
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Xpert HPV
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Cepheid
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CE marked
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E6/E7 target amplification multiplex PCR
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14 HR types(16,18,31,33,35,39,51,52,56,58,59,66 and 68)
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BD HPV Onclarity Assay
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BD
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CE marked
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E6/E7 DNA target amplification, real type PCR
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14 HR types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68)
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Digene HC2 (Hybrid Capture 2) HPV DNA test
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Qiagen
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FDA approved
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Full HPV genome detection by HC2 compared to PCR targeting L1
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13 HR HPV Types 16,18,31,33,35,39,45,51, 52,56,58,59 and 68
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HPV genotyping RH and LX kit
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Qiagen
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L1 consensus PCR with reverse Lineblot detection
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16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82
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careHPV test
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Qiagen
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Application submitted for WHO prequalification
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Hybrid Capture 2 full-length RNA probes and signal amplification, chemiluminescence
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14 HR types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68)
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OncoE6 Cervical Test
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Arbor Vita Corporation
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CE marked
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Monoclonal antibodies in lateral-flow assay format to HPV 16/18 E6.
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16, 18
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Real TimeHigh-Risk HPV
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Abott Molecular
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CE marked
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PCR
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14 HR types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68)
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INNO-LiPA HPV Genotyping Extra*
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Innogenetics
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RUO
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SPF Target amplification. Reverse hybridization line probe assay
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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
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HPV DIRECT FLOW CHIP + E-BRID system
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Master Diagnostic (TaKaRa Shuzo Co. Ltd.)
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reverse dot blot hybridization
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HPV6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 and 82
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PapilloCheck HPV-Screening
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Greiner Bio-One
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CE marked
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PCR, amplicon hybridization on slide for type-specific detection
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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
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PapilloCheck High-risk
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Greiner Bio-One
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CE marked
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PCR, amplicon hybridization on slide for type-specific detection
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14 HR types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68)
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HPV4A ACE Screening kit
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Seegene
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CE marked
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PCR, Gel Electrophoresis
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HPV 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82
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Anyplex II HPV28
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Seegene
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CE marked
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multiplex real-time PCR with proprietary detection system
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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
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Multimetrix Multiplex HPV Genotyping Kit
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MIKROGEN (Germany) also Progen/Multimetrix
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Gp5+/6+ consensus PCR, Luminex
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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
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CLART HPV 2
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Genomica (Spain)
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CE marked
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mulit-plex PCR with visualization in low density arrays
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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)
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GenoFlow HPV Array
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DiagCor (Hong Kong)
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PCR, flow-through hybridization (cassette)
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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
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fHPV Typing
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molGENTIX (Spain)
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CE marked
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15 low risk and high risk types
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HPV 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68
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Trovagene Urine-based HPV test
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Trovagene & Strand Life Sciences (India)--kit under development, test currently performed by Trovagene laboratory
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PCR
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HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68
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13 High-risk HPV Real-Time PCR kit
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Hybribio
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multiplex real-time PCR
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16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68
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PreTect HPV-Proofer
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NorChip AS
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Multi-plex NASBA for HPV E6/E7 mRNA
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HPV 16/18/31/33/45
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CERVIMAX IHC/WB/FC/IC
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VALDOSPAN GmbH
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Antibodies E7
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specialized kits for IHC, WB, FC, IF applications
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NucliSENS easyQ
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Biomerieux
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CE-IVD
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NASBA amplification, real-time detection with molecular beacon probe
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16, 18, 31, 33, 45
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PapType
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Genera Biosystems
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PCR with labeled nucleotides on micro beads
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6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68
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