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womanCACUVPH

Persistent infection with Human Papilloma Virus (HPV) is the main cause of cervical cancer in women. HPV is a very common, sexually transmitted infection, which most people will have during their lifetime.  In some women, HPV infection will persist over time, and if this goes undetected and untreated, it can lead to precancerous cervical lesions and possibly progress to cervical cancer.

HPV testing is used for cervical cancer screening.  It is more sensitive and effective than other screening tests, and can accurately identify women at high risk of developing cervical cancer. There are several HPV testing products available. To aid decision making by cervical cancer program managers in selecting an HPV test for use in their programs, the following charts provide information on the main HPV tests available, along with their main characteristics.

  1. Test name, Company name, Regulatory Status, Type of assay and HPV Types detected. (Table 1)
  2. Format of results, Internal controls for sample adequacy, Collection media, Volume per test, Assay read-out, Equipment needed to process the test. (Table 2)
  3. Batch size, Processing time, Maximum number of tests processed in 8 hr day, Storage conditions and use of the platform for other tests. (Table 3)

Click on the tabs above to access each one of the charts

Download the three tables in one document pdf here .

For more information about HPV testing check the PAHO HPV Testing Manual and the cervical cancer health education materials in the Cervical Cancer page.

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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

HPV Test nameFormat of resultInternal Control for Sample Adequacy (if yes, specify)Collection media/volume per testAssay Read-out (automated, manual-visual, manual-screen)Platform/Equipment needed to process the test
Cervista HPV HR Positive, negative, indeterminate Yes, human HIST2H2BE ThinPrep, 2 mL software processing of fluorescent signal Thermal cycler, fluorescence plate reader, PC with Call Reporter software
Cervista HPV 16/18 Positive, negative, indeterminate Yes, human HIST2H2BE ThinPrep, 2 mL software processing of fluorescent signal Thermal cycler, fluorescence plate reader, PC with Call Reporter software
APTIMA HPV Negative, positive, invalid Yes. Non-infectious RNA transcript (more like external control) 1 mL ThinPrep (2000 processor) Pap Test vials containing PreservCyt Solution. Specimens processed using the ThinPrep 3000 processor or other instruments have not been evaluated RLU from Luminometer Tigris or Panther system
AMPLICOR HPV test positive, negative Yes, human beta-globin 0.25 mL ThinPrep, SurePath (Validated on common liquid based cytology media Absorbance Thermocycler, Amplicor hybridization/detection unit
LINEAR ARRAY HPV Genotyping Test positive/negative for each of the types Yes, ß-globin Thin-Prep 1 mL (can be adapted for any DNA extract from STM, SurePath, FFPE) manual visual Thermocycler, waterbath, shaker, automated hybrization (for high throughput)
Cobas HPV test High-risk HPV positive/negative. Separate HPV16 and 18 results optional in the same test Yes, ?-globin PreservCyt, 1 mL (adaptable to other specimen types with input adjustments) automated automated extractor (cobas 4800x) and RT-PCR detection unit (cobas 4800z)
Xpert HPV HPV 16 and HPV 18/45 in two distinct detection channels. HPV 31, 33, 35, 39, 51, 52, 56, 58, 59, 66 and 68 in a pooled result Yes PreservCyt® Solution, 1 mL   cartridge processor
BD HPV Onclarity Assay 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 - pooled as well as individual types 16, 18, 31, 45, 51, 52 and type groups 33/58, 56/59/66, 35/39/68 Yes, beta globin 0.5 ml LBC media (BD SurePath™, Hologic PreservCyt®) - BD Onclarity cervical brush automated BD Viper LT System
Digene HC2 (Hybrid Capture 2) HPV DNA test high-risk HPV positive/negative No HC2 Specimen Collection Device (cervical brush and STM). PreservCyt Solution or BD SurePath (only CE-IVD mark) automated signal detection and RLU cut-off setting orbital shaker, plate washer, luminometer
HPV genotyping RH and LX kit positive/negative for each of the types Yes, B-Globin STM or PreservCyt Manual, visual manual: waterbath, orbital shaker automated: ProfiBlot 48T (Tecan)
careHPV test qualitative (pos/neg for hr HPV) No careHPV Collection Medium (50 ?l) Automatic (plus/minus display on Test Controller) Test Controller, Luminometer, shaker, magnetic plate holder
OncoE6 Cervical Test positive or negative by type Yes (no indicated) "Dry" Polyester tipped cervical swab ("Dacron" swab). PreservCyt ("Thinprep") media. Self collection (for example, via "Delphi Screener") Visual readout ~ 1 meter of bench space; Small non-refrigerated microcentrifuge; slow tube rotator (AC or battery) P1000 / P200 pipettors, pipet tips, gloves, kim wipe, etc.
Real TimeHigh-Risk HPV Pooled for any type, identification of 16 and 18 Yes, human beta-globin PreservCyt, Sure Path, Abbott Cervi-Collect (400 µL) automated Abbott m2000rt, m2000 System software
INNO-LiPA HPV Genotyping Extra* positive/negative for each of the types Yes, MHC gene various manual, visual (software available Liras) Thermocycler, waterbath, shaker, automated hybrization (for high throughput)
HPV DIRECT FLOW CHIP + E-BRID system   Yes ("housekeeping human gene fragment") Cytological swabs in PBS, cervical cells in liquid cytology media (any), FFPE tissues automated signal detection with hybriSpot 24, manual read with hybriSpot 12 Thermocycler. Microcentrifuge. Thermostatic bath or heating block.DNA flow/chip processor: hybriSpot 12 (semiautomated) or hybriSpot 24 (automated)
PapilloCheck HPV-Screening individual type identification Yes (human gene ADAT1)   automated (scanner) Extractor, thermocycler,hybridization chamber, waterbath, CheckScanner
PapilloCheck High-risk individual type identification Yes (human gene ADAT1)   automated (scanner) Extractor, thermocycler, hybridization chamber, waterbath, CheckScanner
HPV4A ACE Screening kit positive/negative separately for HPV6/11, HPV16, HPV18 or other high risk types Yes Thin-Prep, SurePath manual (bands on gel) Thermocycler, capillary gel electrophoresis
Anyplex II HPV28 positive, negative for individual types, with high, intermediate and low titers Yes Thin-Prep, SurePath automated, sofware interpretation Nimbus IVD (DNA extractor), STARlet (liquid handler), CFX96 (real-time thermal cycler)
Multimetrix Multiplex HPV Genotyping Kit positive, negative for individual types No (only negative and hyb control) Liquid-based cervical cytology specimen automated (luminex) thermomixer, heated incubator, Luminex LX100
CLART HPV 2 type-specific identification Yes, human CFTR gene liquid cytology, swabs, paraffin-embedded tissue automated (image analysis with SAICLART) Thermocycler, microcentrifuge, extractor, thermoblock, CAR (Clinical Arrays Reader) or autoclart
fHPV Typing   Yes, human STR      
Trovagene Urine-based HPV test     Urine, 30 ml    
13 High-risk HPV Real-Time PCR kit Quantitative detection of 13 High Risk HPV types Yes ThinPrep or SurePath, 1 mL manual read out of real-time plots from software DNA extraction equipt, Thermal cycler
PreTect HPV-Proofer type-specific identification Yes, mRNA from human U1 snRNP protein A (U1A) Exfoliated cervical cells in PreTect, ThinPrep or SurePath (volume/test not specified) Automated software required Fluorescent reader and PreTect analysis software package
CERVIMAX IHC/WB/FC/IC   no   manual, visual  
NucliSENS easyQ positive/negative for the 5 hr types intended for cervical specimens collected in PreservCyt automated, pos neg call Real-time NASBA Amplification Platform  
PapType positive/negative for each type Yes ThinPrep 800ml flow data interpreted by "Qplot software" Flow cytometer

HPV Test nameBatch size -specimens per runTotal processing time (Time to result)Maximum number of tests processed in 8 hr dayStorage Conditions Assay reagent stability/storage requirementsOther tests that can be processed using the same platform
Cervista HPV HR   6-7 hours (with 4 hour "walk away" time)   -30°C and -15°C. Cervista HPV16/18
Cervista HPV 16/18       -30°C and -15°C. Cervista HPV HR
APTIMA HPV TIGRES: 100 to 250, PANTHER: 180     Aptima reagents: 2°C to 8°C and 15°C to 30°C ThinPrep: 2°C to 30°C for up to 60 days Trichomonas, HSV1, -2,
AMPLICOR HPV test 96 well plate     Reagents 2°C to 8°C HIV, CT/NG
LINEAR ARRAY HPV Genotyping Test       4°C  
Cobas HPV test 8, 24 48, 72 or 96 samples 5 h/94 samples   4°C HSV1 and 2 MRSA/SA Test, EBV, HIV, CMV, VZV WNV and others
Xpert HPV Jan-80 1h 471 Kits stored 2-28 C Transport at 2-30 C Store 2-30 C for up to 6 months after collection trichomonas, clamydia
BD HPV Onclarity Assay 1-46 samples   120 30 days-30° C (SurePath, PreservCyt, co-collection device) 12 months-30° C (extraction and PCR reagents) CT/GC (planned HSV1&2, Trichomonas)
Digene HC2 (Hybrid Capture 2) HPV DNA test 88 samples 6-7 h for 88 samples, manual (4.5 - 5.5 hours for 352 using RCS automated platform, according to slides)   HC2 kits should be stored at 2-8°C STM samples can be stored for: Up to 2 weeks at room temperature Up to an additional week (3 weeks total) at 2-8°C Up to three months at -20°C PreservCyt specimens may be held for up to 3 months at 2-30°C HPV HR/LR Test CT/GC assay
HPV genotyping RH and LX kit       all reagents at 2-8°C  
careHPV test 80 2.5 h 240 careHPV Test kit between 4°C and 25°C. Clinical specimens in careHPV Collection Medium between 15°C and 30°C for 14 days or between 2°C and 8°C for 30 days No
OncoE6 Cervical Test 15+ 2.5h 45+ 24 months at 15-25°C (no cold chain required) Shorter term elevated temperature storage (> 30°C) permissible Leftover sample can be stored for years at neg. 70°C  
Real TimeHigh-Risk HPV 24 to 96        
INNO-LiPA HPV Genotyping Extra* 20     neg 20° and 4°C  
HPV DIRECT FLOW CHIP + E-BRID system 24 rx     PCR reagents at -20°C, Hybridization reagents at 2 8°C -
PapilloCheck HPV-Screening 12 to 48 5 hours      
PapilloCheck High-risk 12 to 48 5 hours      
HPV4A ACE Screening kit 48 6,5 96 PCR reagents at -20 C  
Anyplex II HPV28 48 6.5 h 96 PCR reagents at -20 C no
Multimetrix Multiplex HPV Genotyping Kit 94   188 neg 20° and 4°C  
CLART HPV 2         CMA (KRAS, BRAF, PI3K, NRAS, iKRAS); STIs; PneomVIr; PneumoCLART bacteria; ENTHERPEX (HSV and enterovirus); EnteroBac; SeptiBac
GenoFlow HPV Array     64    
fHPV Typing   4h      
Trovagene Urine-based HPV test          
13 High-risk HPV Real-Time PCR kit 96 3 h 192 -20°C  
PreTect HPV-Proofer          
CERVIMAX IHC/WB/FC/IC          
NucliSENS easyQ $48 2 h 192    
PapType