COMPARATIVE ANALYSIS OF THE EFFECTIVENESS OF RUSSIAN HPV TESTS BASED ON REAL-TIME PCR FOR DETECTING HIGH CARNCINOGENIC RISK HPV IN CERVICAL SCREENING PROGRAMS
O.Yu. Shipulina, M.S. Abramova, L.I. Korolenkova
For quotation:
Shipulina O.Yu., Abramova M.S., Korolenkova L.I. Comparative analysis of the effectiveness of Russian
HPV tests based on real-time PCR to detect HPV with high carcinogenic risk
in cervical screening programs. Questions of practical colposcopy. Genital infections. 2022; (3): 26–32.
DOI: 10.46393/27826392_2022_3_26
Annotation:
Purpose of the study: to conduct comparative tests of Russian HPV tests for organized screening
and preventive examinations, evaluate the diagnostic and technical characteristics of the kits in screening conditions.
Material and methods. The work used reagent kits (RR) for the determination of human papillomavirus (HPV) of high carcinogenic risk from four Russian manufacturers: “AmpliSens HPV VKR screen-titre-FL”, “AmpliSens HPV VKR screen-titre-14-FL” and “AmpliSens HPV VKR genotype-titer-FL" (FBUN "TsNIIE"), "AmpliPrime HPV VKR 14" and "AmpliPrime HPV VKR 14 genotype" (NextBio LLC), "HPV Kvant-15" and "HPV Kvant-21" (JSC "DNA technology") and "RealBest DNA HPV VKR screen" (JSC "Vector-Best"). The material was DNA samples isolated from scrapings of the cervical canal from women with cervical cancer (L-SIL, H-SIL), in which HPV DNA of types 16, b18, 31, 33, 39, 45 and 52 was found in integrated form (absence of the E1–E2 region of the HPV genome). A total of 56 samples were examined. We also tested 136 scraping samples in BD SurePath in parallel using two screening HPs, AmpliSens and AmpliPrime, to compare quantitative results.
Results. HPV DNA was not detected in any of the 56 samples with an integrated form of the virus using the HP “AmpliSens HPV VKR screen-titre-FL”; it was detected in 52 of 56 samples in the HP “AmpliSens HPV VKR screen-titre-14-FL”, in 22 out of 56 samples - in "HPV Kvant-15", in all 56 - in "AmpliPrime HPV VKR 14", in 20 out of 20 samples - in "RealBest DNA HPV VKR screen". When testing 136 samples with the AmpliPrime and AmpliSens kits, the former showed higher sensitivity and fewer invalid results. HPV DNA quantification demonstrated a high correlation coefficient.
Conclusion. The sensitivity of the HPV test depends on the target chosen for amplification. Tests targeting the E1–E2 region may produce false-negative results when viral DNA is integrated into the cellular genome, whereas tests targeting the E6–E7 region will miss the presence of HCV HPV in such cases. Based on the results obtained and analysis data, we came to the conclusion that the AmpliPrime line kits are the most optimal for HPV screening.
Journal “Issues of practical colposcopy. Genital infections" No. 3_2022
https://drive.google.com/file/d/1OzJMdQ-VCgKHCt0vHydJfiqs8MGZ0xq9/view
O.Yu. Shipulina, M.S. Abramova, L.I. Korolenkova
For quotation:
Shipulina O.Yu., Abramova M.S., Korolenkova L.I. Comparative analysis of the effectiveness of Russian
HPV tests based on real-time PCR to detect HPV with high carcinogenic risk
in cervical screening programs. Questions of practical colposcopy. Genital infections. 2022; (3): 26–32.
DOI: 10.46393/27826392_2022_3_26
Annotation:
Purpose of the study: to conduct comparative tests of Russian HPV tests for organized screening
and preventive examinations, evaluate the diagnostic and technical characteristics of the kits in screening conditions.
Material and methods. The work used reagent kits (RR) for the determination of human papillomavirus (HPV) of high carcinogenic risk from four Russian manufacturers: “AmpliSens HPV VKR screen-titre-FL”, “AmpliSens HPV VKR screen-titre-14-FL” and “AmpliSens HPV VKR genotype-titer-FL" (FBUN "TsNIIE"), "AmpliPrime HPV VKR 14" and "AmpliPrime HPV VKR 14 genotype" (NextBio LLC), "HPV Kvant-15" and "HPV Kvant-21" (JSC "DNA technology") and "RealBest DNA HPV VKR screen" (JSC "Vector-Best"). The material was DNA samples isolated from scrapings of the cervical canal from women with cervical cancer (L-SIL, H-SIL), in which HPV DNA of types 16, b18, 31, 33, 39, 45 and 52 was found in integrated form (absence of the E1–E2 region of the HPV genome). A total of 56 samples were examined. We also tested 136 scraping samples in BD SurePath in parallel using two screening HPs, AmpliSens and AmpliPrime, to compare quantitative results.
Results. HPV DNA was not detected in any of the 56 samples with an integrated form of the virus using the HP “AmpliSens HPV VKR screen-titre-FL”; it was detected in 52 of 56 samples in the HP “AmpliSens HPV VKR screen-titre-14-FL”, in 22 out of 56 samples - in "HPV Kvant-15", in all 56 - in "AmpliPrime HPV VKR 14", in 20 out of 20 samples - in "RealBest DNA HPV VKR screen". When testing 136 samples with the AmpliPrime and AmpliSens kits, the former showed higher sensitivity and fewer invalid results. HPV DNA quantification demonstrated a high correlation coefficient.
Conclusion. The sensitivity of the HPV test depends on the target chosen for amplification. Tests targeting the E1–E2 region may produce false-negative results when viral DNA is integrated into the cellular genome, whereas tests targeting the E6–E7 region will miss the presence of HCV HPV in such cases. Based on the results obtained and analysis data, we came to the conclusion that the AmpliPrime line kits are the most optimal for HPV screening.
Journal “Issues of practical colposcopy. Genital infections" No. 3_2022
https://drive.google.com/file/d/1OzJMdQ-VCgKHCt0vHydJfiqs8MGZ0xq9/view
