Primerjava komercialnih testov za dokazovanje okužb s človeškimi papilomavirusi pri zgodnjem odkrivanju predrakavih sprememb materničnega vratu

Amon, Tadeja (author), Poljak, Mario (mentor)

Rak materničnega vratu in druge maligne spremembe so najhujša posledica okužbe s človeškimi papilomavirusi (HPV). Za dokazovanje okužb s HPV je danes na svetovnem trgu na voljo več kot 200 različnih komercialno dostopnih testov HPV in vsaj 130 variant originalnih testov HPV. V naši raziskavi smo na reprezentativnem vzorcu 1.600 slovenskih žensk starih 20-64 let želeli primerjati tri komercialno dostopne HPV teste: Hybrid capture 2 (hc2), Abbott RealTime High Risk HPV test (Abbott-RT) in 14 High-risk HPV with 16/18 Genotyping Real-time PCR test (HBRT-H14) glede na minimalne kriterije v mednarodno sprejetih priporočilih za varno uporabo testov HPV v klinični praksi. Med 1.600 ženskami, ki so bile vključene v raziskavo, je imelo 127 žensk histološko potrjeno visoko stopnjo intraepitelijske neoplazije (CIN2+), pri čemer je hc2 pravilno prepoznal 120/127 CIN2+ (klinična občutljivost 94,5 %), Abbott-RT 123/127 CIN2+ (96,9 %) in HBRT-H14 122/127 CIN2+ (96,1 %). Test hc2 je bil negativen za hrHPV pri 1.093/1.211 žensk, ki so imele dva zaporedna negativna citološka izvida (klinična specifičnost 90,3 %), Abbott-RT 1.116/1.216 (91,8 %) in HBRT-H14 1.061/1.211 (98.9 %). Klinična občutljivost testov Abbott-RT in HBRT-H14 je bila primerljiva z referenčnim testom hc2 v vseh primerjanih kategorijah (starostna skupina, stopnja lezije), pri čemer so bile vse p-vrednosti <0,05. Dodatno je analitična primerjava testov Abbott-RT in HBRT-H14 nakazovala na visoko strinjanje med testoma (96,1 %) s Kappa vrednostjo 0,85. Na podlagi dobljenih rezultatov lahko sklepamo, da sta HPV testa hc2 in Abbott-RT primerna za klinično uporabo, medtem ko bodo potrebne nadaljnje raziskave, s katerimi se bo potrdila tudi klinična uporabnost testa HBRT-H14.

• Language: Slovenian
• Keywords: virusi, človeški papilomavirus, molekularne tehnike, PCR, Hybrid Capture 2, 14 High-risk HPV with 16/18 Genotyping Real-time PCR, Abbott RaelTime High Risk HPV Test, klinična primerjava, analitična zanesljivost
• Work type: Master's thesis/paper
• Typology: 2.09 - Master's Thesis
• Organization: BF - Biotechnical Faculty
• Publisher: [T. Amon]
• Year: 2019
• PID: 20.500.12556/RUL-106913
• UDC: 578.7:616-006.5:577.2.083
• COBISS.SI-ID: 5040760
• Publication date in RUL: 26.03.2019

Secondary language

• Language: English
• Title: Comparison of comercially available molecular tests for human papillomaviruses in early detection of cervical cancer

Abstract

Cervical cancer and other human papillomavirus (HPV)-related cancers are the worst possible outcome of HPV infection. Thus far more than 200 distinct commercial HPV tests and at least 130 test variants are available on the market as a diagnostic tools. In a representative sample of Slovenian women aged 20-64 years we aimed to compare three commercially available HPV tests: Hybrid capture 2 (hc2), Abbott RealTime High Risk HPV test (Abbott-RT) and 14 High-risk HPV with 16/18 Genotyping Real-Time PCR test (HBRT-H14) according to the international consensus guidelines for primary cervical cancer screening. Out of 1,600 women, a total of 127 were diagnosed with cervical intraepithelial neoplasia grade 2 or worse (CIN2+), of which hc2 correctly identified 120/127, Abbott-RT 123/127 and HBRT-H14 122/127 women, which corresponds to clinical sensitivity of 94.5 %, 96.9 % and 96.1 %. hc2, Abbott-RT and HBRT-H14 were negative for hrHPV in 1,093/1,211, 1,116/1,216 and 1,061/1,211 women with two consecutive negative cytology results, respectively, which corresponds to clinical specificity for >CIN2 of 90.3 %, 91.8 % and 98.9 %, respectively. The noninferiority test revealed that the clinical sensitivity and specificity of the Abbott-RT and HBRT-H14 were non-inferior regardless of the clinical outcome (CIN2+/CIN3+) or age restriction (all p<0.05). In addition, high analytical concordance was observed between the Abbott-RT and HBRT-H14, with an overall agreement of 96.1 % and kappa value of 0.85. Our results suggest that Abbott and hc2 can be considered safe for use in clinical practice, while additional studies are needed to confirm HBRT-H14 as clinically validated.

• Keywords: viruses, human papillomavirus, molecular techniques, PCR, Hybrid Capture 2, 14 High-risk HPV with 16/18 Genotyping Real-time PCR, Abbott RaelTime High Risk HPV Test, clinical comparison, analytical evaluation