HPV Tests For Cervical Cancer Screening

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)

Download the three tables in one document.

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

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

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

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