National Reference Center (NRC) for Human papillomavirus

Important information

Assays for the detection of high-risk human papillomaviruses in the context of Belgian cervical cancer primary screening. 

The table below presents a list of molecular assays for the detection high-risk Human Papillomaviruses (hrHPV). These assays are clinically validated according to international criteria (Arbyn M. et al., Clin Microbiol Infect 20211; Arbyn M et al., ESGO Textbook of Gynaecological Oncology 20232; Dhillon et al., J Med 20233; Arbyn et al., Clin Microbiol Infect 20234). The table below is updated at least twice a year, as new scientific evidence becomes available.

Assay Manufacturer
Alinity m HR HPV Assay Abbott, Wiesbaden, Germany
Allplex II HR Seegene, Seoul, South Korea
Anyplex II HPV HR Detection Seegene, Seoul, South Korea
APTIMA HPV Assay* Hologic, Bedford, MA, USA
*in combination with another mRNA assay (APTIMA HPV16, 18, 45; Hologic) which can identify HPV16 and HPV18,45
Cobas 4800 HPV Test Roche Molecular System, Pleasanton, CF, USA
Cobas 6800 HPV Test Roche Molecular System, Pleasanton, CF, USA
HPV-Risk Assay Self-Screen BV, Amsterdam, The Netherlands
HPV Test Onclarity HPV Assay BD Diagnostics, Sparks, MD, USA
NeuMoDX Qiagen, Ann Arbor, MI, USA
RealTime High Risk HPV Test Abbott, Wiesbaden, Germany
RIATOL HPV genotyping qPCR assay in house, AML, Antwerp, Belgium
Xpert HPV Cepheid, Sunnyvale, CA, USA

List of internationally validated hrHPV assays which can be applied in the Belgian cervical cancer screening (ordered alphabetically).
Updated on 17/03/2024.

DISCLAIMER: This preliminary list contains the internationally validated HPV tests deemed suitable by the NRC-HPV, to the best of our knowledge, for use in the Belgian cervical cancer screening context at the date of publication of this notification. However, this notification is not an official guideline on the topic. Sciensano cannot be held responsible for any differences between this notification and the BELAC guidelines which will be adopted on the topic or other ulterior, related official notifications.


Presentation of the NRC

The species of human papillomaviruses (HPV) comprises more than 200 genotypes among which a dozen are classified by the International Agency for Research in Cancer as carcinogenic. Persistent infection with a carcinogenic (often called high-risk) HPV type is necessary but not sufficient for developing cervical cancer. HPV can also cause other anogenital cancers or oropharyngeal cancers. Cervical cancer is a major public health problem. In 2020, more than 604,000 new cases and 341,000 deaths were reported worldwide (Singh et al., Lancet Glob Health 20235). This renders cervical cancer the third in the World.

The National Reference Center (NRC) for Human Papillomavirus (HPV) is a consortium of three different institutes. Sciensano, Algemeen Medisch Laboratorium (AML) and the University Hospital of Ghent (UZGent) bring their own expertise for quality assurance of HPV diagnosis, for proposing HPV proficiency panels, for HPV surveillance and other HPV projects related to the activities of the NRC.

Sciensano has a world-widely recognized expertise in HPV test validation whereas AML has an extensive experience in routine HPV testing with the use of the in-house, automated and clinically validated RIATOL HPV genotyping qPCR (Dhillon et al., J Med 20233; Benoy et al., J Clin Virol 20196). High volumes of samples can be run in a short timeframe. UZGent contributes to the NRC by offering their expertise Next Generation Sequencing (NGS) using an in-house targeted NGS assay. Request forms for HPV testing for research or monitoring purposes are available by clicking on the links on the panel displayed on the right side of the screen.

The NRC for HPV is involved in several projects such as:

  • The development of a proficiency test with the collaboration of Quality of Laboratories (Sciensano) for assessing HPV-based screening assays. On a yearly basis, a panel of samples is sent to first-line laboratories.
  • The surveillance of HPV genotypes in Belgium. On a yearly basis, screening samples from the three regions are collected and analysed for HPV. A map of HPV genotypes is drawn and the eventual risk of drift towards genotypes not targeted by the commercialized vaccines is assessed.
  • A standard operating procedure for promoting quality in HPV testing by re-analysing seemingly HPV negative high grade squamous intraepithelial lesions (HSIL) and invasive cervical cancer was recently proposed together with the International HPV Reference Center (Pretét et al., Preprint7). It involves the referral of HPV-negative HSIL and invasive cervical cancer to the NRC for retesting and eventual subsequent NGS assay for confirmation of HPV negativity or subsequent identification and characterization of HPV.

Available tests

List of assays performed by the NRC for HPV :

  • RIATOL HPV genotyping qPCR.
    The RIATOL HPV genotyping qPCR assay was developed at AML, Sonic Healthcare Benelux (Antwerp, Belgium) and used in routine screening for more than 15 years under ISO15189 accreditation. The assay comprises a multiplex RT-PCR that detects viral HPV DNA in a quantitative way. RIATOL qPCR is capable of detecting E6 or E7 genes of 18 distinct HPV types separately (i.e. HPV6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 56, 58, 59, 66, 67, and 68). In addition, human βeta-globin is used as both an endogenous cellular quality control and as relative normalizer of viral copies detected for HPV-positive samples.
  • HPV targeted in-house NGS.

Helpful links

At the bottom of this page, you can find the NRC reports.

You can consult the accompanying epidemiological surveillance reports at: Health topic Human papillomavirus (HPV) and cervical cancer


  1. Arbyn M, Simon M, Peeters E, et al. 2020 List of human papillomavirus assays suitable for primary cervical cancer screening. Clin Microbiol Infect 2021; 27(8): 1083-95
  2. Arbyn M, Rousta P, Dhillon SK, et al. Chapter 10: HPV testing on cervical cancer specimens: which assay can be used in cervical cancer screening. In: Ayhan A, ed. ESGO Textbook of Gynaecological Oncology. Istanbul: Günes Publishing; 2023: 115-20.
  3. Dhillon SK, Chung PYJ, Padalko E, et al. Intra- and interlaboratory reproducibility of the RIATOL qPCR HPV genotyping assay. J Med Virol 2023; 95(9): e29093.
  4. Arbyn M, Cuschieri K, Poljak M, Bonde J. Can REALQUALITY RQ-HPV screen be considered as a clinically validated HPV test for use in cervical cancer screening? Clin Microbiol Infect 2023.
  5. Singh D, Vignat J, Lorenzoni V, et al. Global estimates of incidence and mortality of cervical cancer in 2020: a baseline analysis of the WHO Global Cervical Cancer Elimination Initiative. Lancet Glob Health 2023; 11(2): e197-e206.
  6. Benoy I, Xu L, Vanden Broeck D, et al. Using the VALGENT-3 framework to assess the clinical and analytical performance of the RIATOL qPCR HPV genotyping assay. J Clin Virol 2019; 120: 57-62.
  7. Pretét J-L, Mühr LSA, Cuschieri K et al. Human papillomavirus negative high grade cervical lesions and cancers: suggested guidance for HPV testing quality assurance. Available at SSR: at SSRN:

Tests disponibles

Responsible laboratories



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