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Article Index

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