EUROArray HPV

Key Features and Benefits

The EUROArray HPV test offers compliance with international quality criteria for HPV screening tests and independent validation.

• Complete subtyping for qualified assessment of the risk of cervical carcinoma:
  • 18 high-risk HPV subtypes: HPV-16, -18, -26, -31, -33, -35, -39, -45, -51, -52, -53, -56, -58, -59, -66, -68, -73, -82
  • 12 low-risk HPV subtypes: HPV-6, -11, -40, -42, -43, -44, -54, -61, -70, -72, -81, -89
• Highest sensitivity due to detection based on viral oncogenes E6 and E7
• Modular and efficient automation

Unrivalled Top Quality

The EUROArray HPV is the only VALGENT-validated subtyping test providing HPV detection based purely on the viral oncogenes E6 and E7. It stands out among other tests, with only 3 tests providing complete subtyping and only 11 tests meeting VALGENT validation and HPV screening criteria, compared to 254 different HPV tests on the market.

Improved Risk-Based Patient Management

Determination of Individual Risk Based on HPV Subtypes Detected

The risk of cervical carcinoma depends on the HPV subtype detected.

Detection of Persisting Infections with the Same HPV Subtype

CIN2 dysplasia is linked to long-standing infections with the same high-risk HPV subtype. With infections involving changing subtypes, no increase in CIN2 dysplasia incidence was observed. Correspondingly, the risk of developing cervical carcinoma is only increased in persisting infections with the same high-risk HPV subtype.

A graph illustrates the cumulative incidence of CIN2 dysplasia over time since first screening. It shows that persistent infections with a single high-risk HPV subtype lead to a higher cumulative incidence of CIN2 dysplasia compared to sequential infections with different high-risk HPV subtypes.

Detection of Multiple Infections with Different HPV Subtypes

Infections with different HPV subtypes increase the likelihood of cytological changes of the cervical mucosa and therefore yield a higher risk of carcinoma.

Conclusion on Subtyping

Complete subtyping, as provided by the EUROArray HPV, allows for the recognition of persisting infections with the same HPV subtype as well as multiple infections with different HPV subtypes, enabling corresponding risk-based patient management.

Independently Validated Test

VALGENT Validation

The VALGENT (VALidation of HPV GENotyping Tests) protocol provides a comprehensive framework for studies for clinical validation of different HPV tests and for evaluation of a test's suitability for HPV screening. The EUROArray HPV has been VALGENT-validated since 2018.

Fulfils International Criteria for Primary Cervical Cancer Screening

Detection of at Least 13 Defined High Risk HPV Types

The EUROArray HPV enables detection and subtyping of 18 high-risk HPV types (-16, -18, -26, -31, 33, 35, 39, -45, -51, 52, 53, 56, 58, 59, -66, -68, -73, -82) and 12 low-risk HPV types (-6, -11, -40, 42, 43, 44, 54, 61, 70, 72, -81, -89) in only one reaction.

Sensitivity and Specificity

In two independent studies, the EUROArray HPV achieved more than 95% of the sensitivity of the reference test HC2. Bar charts compare the sensitivity of EUROArray HPV and the reference test HC2. In one study, EUROArray HPV showed 106.6% sensitivity while HC2 showed 90%. In another study, EUROArray HPV showed 97.5% sensitivity while HC2 showed 90%.

The EUROArray HPV achieves a specificity of 99.8%. Bar charts compare the specificity of EUROArray HPV and the reference test HC2, showing EUROArray HPV at 99.8% and HC2 at 98%.

Inter- and Intra-Laboratory Reproducibility

The EUROArray HPV achieves an inter- and intra-laboratory reproducibility of 94.5% and 98.4%, respectively, exceeding the minimum requirement of 87%. Bar charts illustrate these reproducibility figures.

CE mark

The EUROArray HPV is CE marked.

** Relative values are shown. Sensitivity and specificity of the reference test HC2 were set to 100%.

Higher Sensitivity with E6 and E7 Detection

A prerequisite for the development of carcinoma is integration of the circular HPV genome into the DNA of the epidermal cells of the patient. The proportion of infected cervical cells containing integrated viral DNA increases as the infection progresses.

A diagram illustrates the progression of HPV infection. It shows circular HPV DNA in a normal cervix, then cervical intraepithelial neoplasia (grades 1-3) with increasing proportions of integrated HPV DNA, and finally invasive carcinoma with fully integrated DNA. The diagram highlights that during integration, genes like E1, E2, L1, and L2 can be split, making tests based on them unreliable. For instance, L1-based tests for the detection of HPV-16 and -18 may miss 8% to 28% of infections.

The EUROArray HPV reliably detects HPV based on the viral oncogenes E6 and E7, which are essential for the malignant transformation of the host cell and are present intact after integration into the human DNA.

Conclusion on E6/E7

Reliable detection systems based on the viral oncogenes E6 and E7, such as provided by the EUROArray HPV, can identify HPV infections with high sensitivity, not only before, but specifically also after the integration of the HPV DNA into the human DNA.

Flexible Test System

Automation Solutions

A workflow diagram shows flexible automation solutions for the EUROArray HPV test. It details the process from DNA extraction (manual or automated, e.g., using chemagic Prepito) through Pre-PCR, PCR (using a PCR cycler), Hybridisation (using a hybridisation station), to Evaluation (using EUROArrayScanner and EUROArrayScan software). The Automated Workstation Pre-NAT II and EUROArray Processor are also featured.

Different Sample Materials Possible

• Cervical and vaginal swab samples
• Swab samples from penile shaft and glans
• Samples from liquid-based cytology
• Anal swab samples
• Formalin-fixed tissues, embedded in paraffin

Scientific Studies Speak for Themselves

Proof of the High Quality of the EUROArray HPV

The EUROArray HPV:

• Meets the international requirements for HPV screening tests according to VALGENT (so-called Meijer criteria).
• Allows to verify the treatment success (e.g., following conisation).
• Delivers reliable subtyping results compared to different other HPV subtyping tests.
• Is suitable for HPV detection in FFPE tissue samples (also from oropharyngeal tumours).
• Has an especially high sensitivity even with self-sampling, unlike other tests.
• Can detect HPV subtypes even in surgery smoke from loop electrosurgical excision procedures.

* Oropharyngeal and self-collected samples as well as surgery smoke have not been validated as sample material for the test system by the manufacturer but have been successfully used in the cited studies.

Product Information

* For research use only, not for in vitro diagnostics

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EUROIMMUN Medizinische Labordiagnostika AG, Seekamp 31, 23560 Lübeck (Germany). Phone: +49 451 2032-0. www.euroimmun.com