Ovrednotenje in primerjava različnih testov za določanje visoko tveganih genotipov človeškega papilomavirusa.

Marinčič, Maja (author), Kloboves Prevodnik, Veronika (mentor)

V Sloveniji presejalni program raka materničenga vratu obsega ženske stare od 20 do 64 let, ki so na 3 leta vabljene na odvzem brisa materničnega vratu. Vzorec se najprej analizira s citologijo. Ob opaženih spremembah celic se naredi triažni hibiridzacijski test Hybrid Capture 2 High-Risk HPV DNA test (HC2, Qiagen, Hilden, Nemčija) in možni dodatni genotipizacijski test Anyplex II HPV HR Detection (Seegene, Seoul, Koreja). Nedavno je prišel na trg nov genotipizacijski test Allplex HPV HR (Seegene, Seoul, Koreja) z izboljšano tehnologijo zaznavanja virusne obremenitve, ki smo ga v naši raziskavi ovrednotili z analizo 330 vzorcev brisa materničnega vratu in primerjavo z zgoraj omenjenima referenčnima testoma in citologijo. Teste smo primerjali z izračuni deležev ujemanj, koeficientom Light in Cohen kappa. Ujemanje vseh testov med seboj je bilo odlično (Light κ = 0,69). Ujemanje med testoma, ki sta trenutno v uporabi, je bilo dobro (κ = 0,56) in ujemanje med HC2 in novim testom je bilo prav tako dobro (κ = 0,56), kar je pričakovano, saj sta genotipizacijska testa bolj analitično občutljiva kot hibridizacijski test HC2 zaradi tehnologije PCR. Ujemanje med genotipizacijskima testoma je bilo popolno (κ = 0,94) in ujemanje med zaznanimi genotipi je bilo popolno pri vseh genotipih HPV z vrednostmi koeficenta kappa 0,83 in več. Nov test ima naprednejšo tehnologijo zaznavanja virusne obremenitve in poda točne Ct vrednosti v primerjavi z referenčnim genotipizacijskim testom. V vzorcih žensk s citologijo visoke stopnje so v večjem deležu prisotni visoko tvegani genotipi HPV16, 18, 31 in 33 kot v vzorcih brez sprememb in citologijo nizke stopnje. Test Allplex HPV HR je popolnoma primerljiv s testom Anyplex II HPV HR Detection in bi ga lahko enako uporabili kot dodaten test pri triažnem testiranju žensk s citološko oceno nizke stopnje.

• Language: Slovenian
• Keywords: rak materničenga vratu, humani papiloma virusi, presejalni program
• Work type: Master's thesis/paper
• Typology: 2.09 - Master's Thesis
• Organization: BF - Biotechnical Faculty
• Year: 2023
• PID: 20.500.12556/RUL-153354
• COBISS.SI-ID: 179052291
• Publication date in RUL: 23.12.2023

Secondary language

• Language: English
• Title: Evaluation and comparison of different tests for the determination of high-risk human papillomavirus genotypes.

Abstract

In Slovenia, the cervical cancer screening programme covers women from 20 to 64 years old, who are invited to have a cervical smear every 3 years. The sample is first analysed by cytology. If cell changes are observed, a triage hybridisation test Hybrid Capture 2 High-Risk HPV DNA test (HC2, Qiagen, Hilden, Germany) and a possible additional genotyping test Anyplex II HPV HR Detection (Seegene, Seoul, Korea) are performed. We evaluated new test Allplex HPV HR (Seegene, Seoul, Korea) with improved detection technology by analysing 330 cervical smear samples and comparing results with reference tests and cytology. The tests were compared by calculations of agreement percentage, Light and the Cohen kappa coefficient. Agreement between all tests was very good (κ=0,69). The agreement between the two reference tests currently in use was good (κ=0,56) and the agreement between HC2 and the new test was also good (κ=0,56), which is expected as the genotyping tests are more analytically sensitive than the HC2 hybridisation test due to the PCR technology. The agreement between two genotyping tests was perfect (κ=0,94). The concordance between the detected genotypes was perfect for all HPV genotypes with kappa coefficient values of 0,83 and above. The new test has more advanced viral load detection technology and gives accurate Ct values compared to the reference genotyping test. High-risk HPV genotypes HPV16, 18, 31 and 33 are in a higher proportion present in the cervical smear samples with high-grade cytology than in samples with no changes and low-grade cytology. As the Allplex HPV HR test is fully comparable to the Anyplex II HPV HR Detection test, it could equally be used as an additional test in triage testing of women with low-grade cytology.

• Keywords: cervical cancer, human papillmaviruses, screening