2023 global inventory of commercial molecular tests for human papillomaviruses (HPV)

Poljak, Mario; Oštrbenk Valenčak, Anja; Cuschieri, Kate; Bohinc, Klara B.; Arbyn, Marc

doi:10.1016/j.jcv.2024.105671

Cited by 9 publications

(1 citation statement)

References 48 publications

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“…Current HPV testing is described in detail in the recent paper by Poljak et al [42], which lists the main groups and subgroups of commercial HPV tests available on the global market in 2023: (1) high-risk HPV DNA screening test without genotyping; (2) high-risk HPV DNA screening test with concurrent partial (HPV16/18/45), concurrent extended, or reflex partial genotyping for main high-risk HPV genotypes, and we expect that the number of different tests in this category will increase remarkably, reflecting updated guidelines and changes in screening and triage practices; (3) HPV DNA full genotyping test; (4) HPV DNA genotype-or group-specific genotyping tests; (5) high-risk HPV E6/E7 mRNA tests. There may be more tests using mRNA in the future; (6) in situ hybridization HPV tests; and (7) HPV DNA tests targeting multiple non-Alpha HPV genotypes.…”

Section: Discussionmentioning

confidence: 99%

Quantification of HPV16 E7 Oncoproteins in Urine Specimens from Women with Cervical Intraepithelial Neoplasia

Makioka,

Inada,

Awano

et al. 2024

Microorganisms

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We present the validity of using an ultrasensitive enzyme-linked immunosorbent assay (ELISA) for quantifying high-risk human papillomavirus (HPV) 16 E7 oncoproteins in urine specimens as a noninvasive method of analyzing the oncogenic activity of HPV. Some reports claim that the oncogenic activity of HPV is a more relevant clinical indicator than the presence of HPV DNA for estimating malignant potential. In the present study, urine containing HPV16 and related types were selected by uniplex E6/E7 polymerase chain reaction and classified according to the pathologic diagnosis of cervical intraepithelial neoplasia (CIN) in cervical biopsy specimens. Our ultrasensitive ELISA was able to detect attomole levels of HPV16 E7 oncoproteins, and it detected HPV16-positive SiHa cells at >500 cells/mL without detecting HPV18-positive cells. Our ELISA results showed E7 oncoproteins in 80% (4/5) of urine specimens from women with HPV16-positive CIN1, 71% (5/7) of urine specimens from CIN2 patients, and 38% (3/8) of urine specimens from CIN3 patients. Some urine specimens with undetectable E7 oncoproteins were thought to be negative for live HPV 16-positive cells or in an inactivated state of infection. These results provide the basis for assessing oncogenic activity by quantifying E7 oncoproteins in patient urine.

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Section: Discussionmentioning

confidence: 99%

Quantification of HPV16 E7 Oncoproteins in Urine Specimens from Women with Cervical Intraepithelial Neoplasia

Makioka,

Inada,

Awano

et al. 2024

Microorganisms

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Clinically validated HPV assays offer comparable long‐term safety in primary cervical cancer screening: A 9‐year follow‐up of a population‐based screening cohort

Oštrbenk Valenčak,

Kroon,

Fabjan

et al. 2024

Intl Journal of Cancer

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Molecular testing for human papillomaviruses (HPV) is gradually replacing cytology in cervical cancer screening. In this longitudinal population‐based cohort study, 4140 women 20 to 64 years old attending organized screening were tested at baseline by five different screening methods and followed for 9 years. To assess long‐term safety, the cumulative risks of CIN2+/CIN3+ were estimated after a negative baseline result obtained by conventional cytology and four clinically validated HPV assays: Hybrid Capture 2 (hc2), RealTime High Risk HPV assay (RealTime), cobas 4800 HPV Test (cobas_4800), and Alinity m HR HPV (Alinity). HPV‐negative women at baseline had a substantially lower risk for CIN2+ compared to those with normal baseline cytology: 0.84% (95% CI, 0.46–1.22), 0.90% (95% CI, 0.51–1.29), 0.78% (95% CI, 0.42–1.15), and 0.75% (95% CI, 0.39–1.11) for hc2, RealTime, cobas_4800, and Alinity, respectively, compared to 2.46% (95% CI, 1.88–3.03) for cytology. No differences were observed between HPV assays in longitudinal sensitivity (range: 86.21%–90.36%) and negative predictive values (range: 99.54%–99.70%) for CIN2+ in women ≥30 years, but were significantly different from cytology (p < .05). The 9‐year cumulative risk of CIN2+ differed significantly between HPV genotypes, reaching 32.1% (95% CI, 14.5–46.1) for HPV16, 24.9% (95% CI, 4.7–40.8) for HPV18/45, 27.2% (95% CI, 14.6–37.8) for HPV31/33/35/52/58, and 8.1% (95% CI, 0.0–16.7) for HPV39/51/56/59. Four clinically validated HPV assays showed comparable safety and better assurance against precancerous lesions than cytology, but some important differences were identified in the performance characteristics of HPV assays impacting the referral rate. Information about the HPV genotype is valuable for guiding further clinical action in HPV‐based screening programs.

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The Sansure® Human Papillomavirus DNA Diagnostic Kit offers excellent reproducibility performance for the detection of high‐risk HPV

Prétet,

Baraquin,

Chung

et al. 2024

Journal of Medical Virology

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Cervical cancer screening is a cornerstone of cervical cancer elimination. Detection of high‐risk human papillomavirus (hrHPV) is recommended as the first step in screening provided that the assay used has been adequately validated. The Sansure® Human Papillomavirus DNA Diagnostic Kit is a new assay designed to detect HPV16, HPV18 and 13 other HPV in aggregate. The study aimed to evaluate the intra‐ and interlaboratory reproducibility of the assay according to international guidelines. Five hundred and fifty cervical residual cell samples from women attending cervical cancer screening were selected from the biobank of the HPV National Reference Centre in Belgium and used in this study. After DNA extraction, HPV was tested using the Sansure® Human Papillomavirus DNA Diagnostic Kit. The lower 95% confidence limit around the general reproducibility of this assay should be greater than or equal to 87%, with κ ≥ 0.50. Five hundred and thirty‐three samples had valid results. The Sansure® Human Papillomavirus DNA Diagnostic Kit demonstrated an excellent intra‐laboratory reproducibility of 93.8% (95% confidence interval [CI]: 91.4–95.7, κ = 0.85). The interlaboratory reproducibility was 93.4 (95% CI: 91.0–95.4, κ = 0.84). Intra and interlaboratory reproducibility were also excellent at the genotype level. Excluding HPV53 single infection samples from the analyses also resulted in excellent agreement. These data show that the Sansure® Human Papillomavirus DNA Diagnostic Kit is highly reproducible.

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2023 global inventory of commercial molecular tests for human papillomaviruses (HPV)

Cited by 9 publications

References 48 publications

Quantification of HPV16 E7 Oncoproteins in Urine Specimens from Women with Cervical Intraepithelial Neoplasia

Quantification of HPV16 E7 Oncoproteins in Urine Specimens from Women with Cervical Intraepithelial Neoplasia

Clinically validated HPV assays offer comparable long‐term safety in primary cervical cancer screening: A 9‐year follow‐up of a population‐based screening cohort

The Sansure® Human Papillomavirus DNA Diagnostic Kit offers excellent reproducibility performance for the detection of high‐risk HPV

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