TEST:

cobas® HPV test

The assay has demonstrated a high intra- and inter-laboratory reproducibility, also among the individual genotypes. The Vitro HPV Screening assay is valid for cervical cancer screening and it provides genotyping information on HPV-positive samples without further sample processing in a fully automated workflow.

These data suggest that self-collected vaginal samples enable accurate clinical HPV testing, and that extended ambient dry storage or exposure to extreme temperatures do not influence HPV detection. Further, lack of β-globin amplification in HPV negative samples accurately identified participants that required recollection.

Pap smear abnormalities were detected in 31 patients (3.5 %), and 19 patients had high-risk HPV. Using HPV NGS for screening, rare HPV subtypes were detected, and quantitative values were obtained as read depth.

While this study demonstrated a reasonable kit return rate and indicated the capability of opt-in HPV self-sampling to detect CIN2+ cases in unscreened women, the low ordering rate of kits and suboptimal compliance for follow-up cytology testing highlight significant challenges. The findings suggest the need for more effective strategies to enhance participation in cervical cancer screening programs.

This study highlights that HR-HPV other types are more prevalent in anal ASCUS cases compared to the cervical ASCUS cases, where HR-HPV 16 is more common. Our findings support the use of concurrent cytology and HR-HPV testing for anal cancer screening. Co-testing significantly enhances the specificity of atypical cytology diagnoses, enabling more accurate patient triaging.

This study emphasizes the continued increase in HPV 16 rates despite advancements in vaccination and screening. Additionally, it highlights the need for ongoing vigilance and research in the post-vaccination era to determine the clinical significance of high-risk HPV non-16/18 genotypes which maintain a higher prevalence in our population. Larger retrospective studies are necessary to determine the need for expanded vaccination coverage and effective strategies to monitor and treat HPV-related diseases.

Women undergoing allo-HSCT are at higher risk of HPV infection and premalignant lesions, and consequently, screening programs should be strictly followed- However, pathologists should be aware of the cytological abnormalities associated with busulfan, which may closely mimic HPV-associated lesions.

This is the largest study on ASC-H Pap with HPV genotyping.hrHPV positive rate was 84.4% in women with ASC-H Pap. HPV16, -52, -58, -33, -31 were the most common five HPV types. 16.4% CIN2+ lesions and 3.9% cancer caseswere detected in women with ASC-H and negative hrHPV testing.The study indicated all women with ASC-H Pap should have colposcopic assessmentas optimal clinical practice.

"The excellent intra- and interlaboratory reproducibility and the established clinical performance, together with the platforms' simplicity, make these assays particularly applicable to low-resource settings."

P=N/A; Enrolling by invitation --> Completed | N=240 --> 149

All methods differed in their sensitivity and specificity. HPV genotyping contributes to individual risk stratification, therapeutic decisions, epidemiological studies and vaccine development, supporting approaches in prevention, healthcare and management of HPV infection.

HPV DNA testing from self-collected specimen to detect HR-HPV demonstrates high concordance with HPV mRNA testing from clinician-collected specimen. The sensitivity and negative predictive value of both tests to detect high-grade lesions are comparable.

Two women tested positive for HPV16 and hrHPV (non-18); of those one had positive CINtec, and HGSIL cytology, and the other had negative CINtec and ASCH. Conclusion Among women with CIN2 the rate of a positive CINTEC+ test is lower than that of cytology testing, possibly reflecting a difference in the oncogenic potential of CIN2 cases.

Improved test accuracy could be achieved with urine-specific thresholds for HPV positivity. Urine is broadly acceptable to attenders and some groups of non-attenders (eg LGBTQIA+) but others (eg ethnically diverse) may prefer clinician sampling, making choice important.

The highest prevalence of hr-HPV positive women was in the age group 25-29 years (7,8%) and the lowest in the age group 45-49 years (4,1%). Conclusion The presence of hr-HPV was detected in 6,9% (n=236) of tested women from disadvantaged communities and marginalized regions, while another type of hr-HPV was most represented in 69,1% (n=163).

human papillomavirus positivity was not detected in all urine samples. It is still inappropriate to recommend the use of urine liquid biopsy for the accurate and reliable detection of human papillomavirus. Due to the lack of a standardized tool, the utilization of urine samples as a screening human papillomavirus test remains a challenge.

Testing with automated cobas 4800 system showed 96.7 % concordance (198 concordant-negative, 34 concordant-positive, Cohen's kappa=0.87). HPV testing on Colli-Pee urine offers advantages for acceptable non-invasive HPV screening.

P=N/A; N=240; Enrolling by invitation; Sponsor:University of Wisconsin, Madison

This study has successfully established a detection method capable of simultaneously identifying 16 HPV genotypes. This approach can be further applied to HPV vaccine research and surveillance, with the potential for broad applications.

Especially for Lacticaseibacillus, we observed significant depletion in the case of HPV16, HPV18 versus hrHPVother. Overall, our results suggest that the presence or absence of specific cervicovaginal microbial genera may be linked to the observed severity in hrHPV infection, particularly in the case of HPV16, 18 types.

"This study further confirmed the feasibility of self-test at home screening strategy based on self-sampling with an opt-in system as a support method to enhance cervical cancer screening coverage in Italy. Enrolled women showed a high appreciation for this approach. HPV Selfy test demonstrated to be a valuable assay for cervical cancer screening based on home self-collection."

Cobas HPV testing was highly efficacious for predicting CIN2+ lesions in the low-risk CPC population, which supports HPV primary screening for cervical cancer in low-risk populations. For high-risk patients, especially those with a history of CIN2+/cervical cancer, HPV/Pap cotesting may still be necessary to maintain a high clinical sensitivity for CIN2+.

When self-collected HPV testing is used as the primary testing, the internet-based data platform facilitates the screening in registration, data collection, and data tracking, and increases the screening coverage. Internet-facilitated community model is promising to cervical cancer control and applicable in regions with variety of resources.

We found a good agreement and similar performance to detect HPV-16, HPV-18, and the 12 other hrHPV genotypes. The global performance to detect the 14 hrHPV genotypes was not significantly different between the 2 assays.

Attributable risk of all HR-HPV genotypes targeted by both Anyplex and cobas tests was evident in ⩾CIN2/AIS Testing for these genotypes in HPV primary cervical screening and cytology triage could identify those at increased risk of cervical cancer and also be beneficial in the management of LSIL referral populations.

Ct value represented a good triage marker in both PCR-based and isothermal amplification HPV detection.

Genotyping data was comparable across both assay platforms. In the context of HPV primary screening HPV mRNA testing has potential to reduce triage tests and follow-up tests at 12 months compared to DNA testing, with no significant difference in detection of CIN2+ and CIN3+.

"Roche announced today the recent U.S. Food and Drug Administration (FDA) approval of the cobas® HPV test for use on its next-generation cobas® 5800 molecular instrument. This new approval will broaden access to HPV testing in mid-size and smaller labs in the U.S. to help enable accurate and timely diagnosis of patients who are at risk of developing cervical cancer."

Molecular and epidemiological studies have strongly demonstrated the link between high-risk HPV types and squamous cell carcinoma of the cervix. The Alinity m HR HPV (IUO) assay was designed for first-line primary screening, co-testing with cytology, and ASC-US triage applications. Screening for cervical cancer remains an important public health and economic concern where HPV DNA tests can be effectively used in triaging patients with equivocal cytology, in post- therapeutic follow-up, and in monitoring vaccine efficacy.

P=N/A; N=900; Completed; Sponsor:PT Bio Farma

The study included 108 cases, for which the sample-inadequacy rate was 4.6% (5/108 cases). Patient's mean age was 44.0 ± 8.1 with 75.0% aged 30-49 years. Among 103 qualified cases, positive rates for HPV16, HPV18 and 12 other high-risk HPV types were 0.97%, 0% and 2.91% respectively in self-collected versus 0.97%, 0.97% and 2.91% in physician-collected samples.

The index and predicate HPV assays demonstrated equivalent performance, and extended HPV genotyping, using the index assay, provided effective ≥CIN2 and ≥CIN3 risk stratification, supporting a new indication for use of the index assay with PreservCyt.

HPV 18 affects KR, koilocytosis, nuclear membrane irregularity, enlargement, and nuclear diameters. Light microscopic analysis of these abnormalities increases the sensitivity and specificity of cytology in the evaluation of cellular pictures due to HPV 18.

Consequently, these results underscore the necessity for a larger-scale study with an expanded sample size encompassing cytology and HPV testing. Such an investigation would be invaluable in facilitating the development of a national prevention program to effectively control cervical cancer.

It is necessary to have a laboratory solution to automate the process. Self-sampling in cervical cancer screening has been widely accepted among female participants, which is expected to translate into increased participation and eventually coverage.

P=N/A; Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Jul 2023 --> Jul 2024

The findings indicate a high frequency of HR-HPV and a considerable frequency of Chlamydia trachomatis in the Indigenous women of XIP. The detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and/or HR-HPV does not present evidence of a potential interrelationship for a combined pathogenic action in these women.

So far, no studies have been conducted on the value of P16/Ki-67 ICC for CIN2 surveillance. If the study identifies high correlation of P16/Ki-67 ICC to colposcopy, larger studies could be designed to investigate longer-term reassurance for the surveillance of women with untreated CIN2 without colposcopy.

HPV prevalence was 8%, with HPV 52 being the most common high-risk type, making it a necessity to develop a diagnostic kit and vaccine for national vaccination program that is specific for Indonesian population which includes this genotype.

The high concordance, reproducibility, and clinical performance of the current assay suggest that the urine-based HPV test fulfills the requirements for its use in primary cervical screening. Moreover, it has the potential to be used for mass screening to not only identify high-risk individuals, but also to monitor vaccine effectiveness.

After 3 years, 14 (9.3%) of the 150 women who were still undergoing follow-up were diagnosed with histologic HSIL+ lesions, of which 5 (35.7%) had baseline NILM cytology. Despite the small sample, the results of this study allow us to conclude that reflex cytology is not useful for discrimination to immediate referral for colposcopy in women who test positive for HPV 16 and/or 18, as most women with a histologic diagnosis of an HSIL+ lesion had <HSIL reflex cytology.

"Roche...announced that the cobas® HPV test for use on the cobas® 6800/8800 Systems has been awarded World Health Organization (WHO) prequalification. WHO prequalification expands the availability of this critical HPV screening tool in countries that rely on the global organisation’s list in making purchasing and implementation decisions."