Pruebas de VPH para el Tamizaje del Cáncer Cervicouterino

La infección persistente por el virus del papiloma humano (VPH) es la causa principal de cáncer de cuello uterino en las mujeres. El VPH, transmitido sexualmente, es una infección muy común y la mayoría de las personas pueden tenerla alguna vez en su vida. En algunas mujeres, el VPH va persistir por mucho tiempo y si no se detecta y trata, la infección puede desarrollarse en lesiones precancerosas y posiblemente progresar a cáncer de cuello uterino.

La prueba de VPH es usada para el tamizaje del cáncer cervicouterino. Es más sensible y eficaz que otras pruebas de detección, y puede identificar con precisión las mujeres con alto riesgo de desarrollar cáncer de cuello uterino. Hay deferentes productos de pruebas de VPH disponibles. Para facilitar la toma de decisiones por los directores de los programas de cáncer cervicouterino en la selección de una prueba de VPH para su uso en sus programas, las tablas siguientes proporcionan información sobre las principales pruebas del VPH disponibles, junto con sus principales características.

Nombre de la prueba, Nombre de la compañía, Situación normativa, y Tipos de VPH detectados. (Tabla 1)
Formato de los resultados, Controles internos para la adecuación de la muestra, Recopilación de medios, Volumen por prueba, Lectura del ensayo, Equipo necesario para procesar la prueba. (Tabla 2)
Tamaño del lote, Tiempo de procesamiento, Número máximo de pruebas procesadas en 8 horas por el día, Condiciones de conservación y uso de la plataforma para otras pruebas (Tabla 3)

Haga un clic en las pestañas de abajo para acceder a cada una de las Tablas.

Descargar las tres tablas en un documento.

Para más información sobre las pruebas de VPH, chequear el Manual de VPH de la OPS y el material educativo del cancer cervicouterino en la pagina de la web sobre el Cáncer Cervicouterino

HPV Test name	Company name	Regulatory Status	Type of Assay	HPV 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 name

Company name

Regulatory Status

Type of Assay

HPV 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

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 name	Format of result	Internal Control for Sample Adequacy (if yes, specify)	Collection media/volume per test	Assay 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 name

Format of result

Internal Control for Sample Adequacy (if yes, specify)

Collection media/volume per test

Assay 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

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)

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

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 name	Batch size -specimens per run	Total processing time (Time to result)	Maximum number of tests processed in 8 hr day	Storage Conditions Assay reagent stability/storage requirements	Other 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

HPV Test name

Batch size -specimens per run

Total processing time (Time to result)

Maximum number of tests processed in 8 hr day

Storage Conditions Assay reagent stability/storage requirements

Other 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

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

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

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*

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

6,5

PCR reagents at -20 C

Anyplex II HPV28

6.5 h

PCR reagents at -20 C

Multimetrix Multiplex HPV Genotyping Kit

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

fHPV Typing

Trovagene Urine-based HPV test

13 High-risk HPV Real-Time PCR kit

3 h

192

-20°C

PreTect HPV-Proofer

CERVIMAX IHC/WB/FC/IC

NucliSENS easyQ

$48

2 h

192

PapType