EUROIMMUN EURO Array HPV Screening User Guide

EUROIMMUN EURO Array HPV Screening User Guide

Product Information: EUROArray HPV

Specifications

• Compliance with international quality criteria for HPV screening tests
• 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
• CE marked

Product Usage Instructions

DNA Extraction
Extract DNA from the sample using a manual (column-based) method or a chemagic Prepito* automated workstation.

Pre-PCR
Prepare the extracted DNA sample for PCR amplification.

PCR
Perform PCR amplification of the DNA sample using a PCR cycler.

Hybridisation
Hybridize the PCR-amplified DNA sample with the EUROArray HPV probes.

Evaluation
Evaluate the hybridized DNA sample using the EUROArrayScanner and EUROArrayScan software. Please note that the Chemagic Prepito is for research use only.

For the highest quality HPV screening

• 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

Features of HPV tests in comparison

Based on data from the study by Poljak et al. (2020) on the spectrum of worldwide available molecular HPV tests’

GO FOR COMPLETE SUBTYPING!

For improved risk-based patient management owing to …
Determination of the individual risk based on the HPV subtypes detected

HPV subtype and risk for CIN3+ (categorisation according to Bonde et al.) 2 The risk of cervical carcinoma depends on the HPV subtype detected. 2, 3,4

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 with changing subtypes, however, no increase in the incidence of CIN2 dysplasia was observed. Correspondingly, the risk of developing cervical carcinoma is only increased in persisting infections with the same high-risk HPV subtype.5

The proportion of women who develop CIN2 dysplasia after a persistent infection with a single high-risk HPV subtype or after sequential infections with different high-risk HPV subtypes (modified from Elfgren et al.)

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. 6. 7

CONCLUSION: Only complete subtyping, as provided by the EUROArray HPV, allows to recognise persisting infections with the same HPV subtype as well as multiple infections with different HPV subtypes and enables a corresponding risk-based patient management.

TRUST AN INDEPENDENTLY VALIDATED TEST!

With 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 2018.9

Fulfils international criteria for primary cervical cancer screening 10

• **Detection of at least 13 defined high-risk HPV types:***
  • The EUROArray HPV enables the 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.
  • HPV-16, – 18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59 and -68
• At least 90% of the sensitivity for CIN2+ of an established and validated HPV test
• At least 98% of the specificity for CIN2+ of an established and validated HPV test
• Inter- and intra-laboratory reproducibility of at least 87%

CE mark
The EUROArray HPV is CE-marked.

• Relative values are shown. The sensitivity and specificity of the reference test HC2 were set to 100%.

GO FOR A TEST BASED ON E6 AND E7!

• For higher sensitivity even after the integration of HPV DNA into the host DNA
  A prerequisite for the development of carcinoma is the 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 (see figure). 2-15

• The course of an untreated, persistent HPV infection. The circular DNA genome of HPV is linearised and integrated into the DNA of the cervical cells of the host. Genes that are responsible for regulating the oncogenes E6 and E7 are lost during this process, leading in the long-term to invasive carcinoma.

• During the integration into human DNA, particular regions of the HPV genome (generally the E1, E2, L1 and L2 genes) are split, which is why tests based on the detection of these genes are unreliable: For instance, L1-based tests for the detection of HPV-16 and -18 may miss 8% to 28% of infections. ‘

• The EUROArray HPV, however, reliably detects HPV based on the viral oncogenes E6 and E7, which are essential for the malign transformation of the host cell and are present intact after integration into the human DNA. 12,17

CONCLUSION: Only reliable detection systems based on the viral oncogenes E6 and E7, such as those 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.

BENEFIT FROM A FLEXIBLE TEST SYSTEM!

Different flexible automation solutions

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). 9, 11
• allows to verify the treatment success (e.g. following conisation).”
• delivers reliable subtyping results compared to different other HPV subtyping
• is suitable for HPV detection in FFPE tissue samples (also from oropharyngeal tumours*). 19, 20
• has an especially high sensitivity even with self-sampling – unlike other
• can detect HPV subtypes even in surgery smoke from loop electrosurgical excision procedure._

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

References

1. Poljak M et al., Clin Microbiol Infect 26:1144-1150 (2020).
2. Bonde JH et al., J Low Genit Tract Dis 24(1):1-13 (2020).
3. Liverani CA et al., J Oncol. 2020:8887672 (2020).
4. Demarco M et al., EClinicalMedicine 22:100293 (2020).
5. Elfgren K et al., Am J Obstet Gynecol 216(3):264.e1-264.e7 (2017).
6. Trottier H et al., Cancer Epidemiol Biomarkers Prev 15(7):1274-80 (2006).
7. Dickson EL et al., Gynecol Oncol 133(3):405-408 (2014).
8. Arbyn M et al., J Clin Virol 76(1):S14-21 (2016).
9. Viti J et al., J Clin Virol 108:38-42 (2018).
10. Meijer et al., Int J Cancer, 124:516-520 (2009).
11. Cornall AM et al., Eur J Clin Microbiol Infect Dis 35(6):1033-1036 (2016).
12. Tjalma WA et al., Eur J Obstet Gynecol Reprod Biol 170(1):45-46 (2013)
13. Andersson S et al., Br J Cancer 92(12):2195-2200 (2005).
14. Cullen AP et al., J Virol 65(2):606-612 (1991).
15. Watts KJ et al., Int J Cancer 97(6):868-874 (2002).
16. Park JS et al., Gynecol Oncol 65(1):121-129 (1997).
17. Morris BJ, Clin Chem Lab Med 43(11): 1171-1177 (2005).
18. Cornall AM et al., Papillomavirus Res 4:79-84 (2017).
19. Kriegsmann M et al., J Clin Pathol 70(5):417-423 (2016).
20. Maroun CA et al., Infect Agent Cancer 6(15):1. (2020).
21. Mangold BR, Acta Cytol 63(5):379-384 (2019).
22. Neumann K et al., Arch Gynecol Obstet 297(2):421-424 (2018).

FAQ

Q: What HPV subtypes does EUROArray HPV detect?
A: EUROArray HPV detects 18 high-risk HPV subtypes (HPV-16, -18, -26, -31, -33, -35, -39, -45, -51, -52, -53, -56, -58, -59, -66, -68, -73, -82) and 12 low-risk HPV subtypes (HPV-6, -11, -40, -42, -43, -44, -54, -61, -70, -72, -81, -89).

Q: What is the sensitivity of EUROArray HPV?
A: EUROArray HPV has a sensitivity of at least 90% for detecting CIN2+ (cervical intraepithelial neoplasia grade 2 or higher).

Q: What is the specificity of EUROArray HPV?
A: EUROArray HPV has a specificity of at least 98% for detecting CIN2+.

Q: Is EUROArray HPV independently validated?
A: Yes, EUROArray HPV has been independently validated and achieved more than 95% of the sensitivity of the reference test HC2 in two independent studies.

EUROIMMUN Medizinische Labordiagnostika AG
Seekamp 31
23560 Lübeck (Germany)
Phone: +49 451 2032-0
www.euroimmun.com
MN_2540_L_UK_D10, 02/2023

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