Comparison of the ScreenFire and Xpert HPV assays for the detection of human papillomavirus and cervical precancer among women living with HIV in Malawi

Mungo, Chemtai; Guliam, Anagha; Chinula, Lameck; Inturrisi, Federica; Msowoya, Lizzie; Mkochi, Tawonga; Jawadu, Siniya; de Sanjosé, Silvia; Schiffman, Mark; Tang, Jennifer H.; Smith, Jennifer S.

doi:10.1186/s13027-024-00585-4

Cited by 3 publications

References 42 publications

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A cervical cancer control strategy for lower-resource settings: interventions to complement one-dose HPV vaccination

Campos,

Lowy,

de Sanjosé

et al. 2024

JNCI Monographs

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One-dose prophylactic HPV vaccination of pre-adolescents may reduce cervical cancer deaths dramatically in lower-resource settings, but the benefits of achieving immediate high coverage among pre-adolescents would not be realized for 20 to 40 years. Prophylactic vaccine efficacy is reduced after sexual debut, and current therapeutic intervention candidates designed to treat existing HPV infections or precancerous lesions have yielded insufficient evidence to warrant widespread use. However, we are developing a feasible, scalable, high-quality cervical screening approach that could prevent hundreds of thousands of deaths, while we work to achieve high coverage of one-dose vaccination for adolescent cohorts. A time-limited “one screen” campaign approach for lower-resource settings could complement parallel efforts to achieve high coverage with one-dose vaccination. This screen-triage-treat strategy would target the highest risk groups of screening age (ie, 25 to 49 years) for once-in-a-lifetime HPV testing of self-collected samples using a low-cost accurate HPV test; subsequent triage relying on extended genotyping and a validated deep-learning algorithm for automated visual evaluation (AVE) would stratify management based on risk to provide treatment for those most likely to develop cancer without overburdening health care systems. Early efficacy of this approach has been demonstrated in 9 countries within the HPV-AVE (PAVE) Study Consortium. We estimate that the cost per death averted of a screen-triage-treat campaign is of similar magnitude to prophylactic vaccination. We do not envision perpetual investment in ubiquitous brick-and-mortar screening programs if “one dose, one screen” is implemented with high coverage and targets the highest-risk populations. In collaboration with in-country stakeholders, efforts to ensure acceptability, risk communication, and cost-effectiveness are underway.

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A cervical cancer control strategy for lower-resource settings: interventions to complement one-dose HPV vaccination

Campos,

Lowy,

de Sanjosé

et al. 2024

JNCI Monographs

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Validation of a simplified HPV genotyping assay designed for cervical screening in low-resource settings

Desai,

Ajenifuja,

Adepiti

et al. 2024

Preprint

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IntroductionHuman papillomavirus (HPV) genotype predicts cervical cancer risk, and genotyping could help guide management of HPV positives as part of cervical screening. An isothermal amplification HPV extended genotyping test (ScreenFire HPV RS assay) can assay up to 96 controls/samples in one hour plus preparation time. A novel format with pre-aliquoted reagents and an anti-contamination component (Zebra BioDome™) could simplify the HPV testing process by substantially reducing the assay preparation time and the chances of post-amplification contamination. We validated Zebra BioDome formulation prior to its clinical use.MethodsResidual provider-collected cervical samples (n=450) from a population-based study in rural Nigeria were retested with ScreenFire, once using the standard assay version (liquid reagents combined onsite) and twice with Zebra BioDome. HPV results with adequate DNA (N=427) were analyzed channel-by-channel and using the cervical cancer risk-based hierarchy of HPV type channels (HPV16, else 18/45, else 31/33/35/52/58, else 39/51/56/59/68, else high-risk HPV negative) to evaluate Zebra BioDome repeatability and accuracy against the standard version.ResultsZebra BioDome reduced the number of pipetting steps to run the ScreenFire HPV assay. Following amplification, the BioDome material formed a sealant layer above the reaction components. Zebra BioDome had excellent repeatability and agreement with the standard version, both at the channel-specific analysis [positive percent agreement between 88.4% (HPV39/51/56/59/68) and 100% (HPV16); negative percent agreement between 97.8% (HPV31/33/35/52/58) and 100% (HPV39/51/56/59/68)] and hierarchical analysis (overall agreement 97.2%).ConclusionsThe assay version utilizing Zebra BioDome performed similarly to the previously validated standard version of the ScreenFire HPV assay and is now undergoing field evaluation. This solution has the potential to reduce assay preparation time and risk of contamination, providing a simpler, low-cost, near-point-of-care HPV testing and extended genotyping solution for cervical screening in lower-resource settings. Potential application of Zebra BioDome technology to other DNA amplification assays should be considered.

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Analytic performance of ScreenFire HPV RS assay Zebra BioDome format and its potential for large-scale population HPV screening

Wang,

Imade,

Akanmu

et al. 2024

Infect Agents Cancer

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Background Easy-to-use, rapid, scalable, high-throughput, and cost-effective HPV tests are urgently needed for low-resource settings. Atila Biosystems’ high-throughput, cost-effective, and clinically validated ScreenFire HPV Risk Stratification (RS) assay identifies 13 high risk HPV (hrHPV) in 4 groups based on their oncogenic risk (i.e., HPV16, HPV18/45, HPV31/33/35/52/58, and HPV51/59/39/56/68). The current standard format is subject to laboratory contamination, which is common for any molecular PCR test. To overcome this drawback, Atila has recently upgraded it into an innovative, contamination-free Zebra BioDome format. The contamination-free feature makes this novel assay format more suitable for large-scale community- and population-based cervical screening. This study evaluated the analytical performance of the Zebra BioDome format. Methods We conducted a study to test the analytical performance of Zebra Biodome format in comparison to the results of using the ScreenFire HPV RS assay standard format on Biorad CFX-96 real-time PCR instrument. We used overall agreement rate and unweighted kappa value to compare the performance. Results The overall agreement for detection of hrHPV was 96.0% with unweighted kappa value 0.94 (95% confidence interval: 0.90–0.98). The agreement rates between hrHPV genotype 16 and risk stratification genotype group (HPV18/45, HPV31/33/35/52/58, and HPV51/59/39/56/68) were all > 97.5%. Conclusion The innovative ScreenFire HPV RS assay Zebra BioDome format produced highly concordant results with the standard format. The shared features by the two assay formats, such as easy-to-use, high throughput, cost-appropriate, and no requirements for DNA extraction. The unique contamination-prevention feature along with no requirement of preparation of reagents make the Zebra BioDome format more suitable for large-scale HPV screening to reduce global cervical cancer burden.

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Comparison of the ScreenFire and Xpert HPV assays for the detection of human papillomavirus and cervical precancer among women living with HIV in Malawi

Cited by 3 publications

References 42 publications

A cervical cancer control strategy for lower-resource settings: interventions to complement one-dose HPV vaccination

A cervical cancer control strategy for lower-resource settings: interventions to complement one-dose HPV vaccination

Validation of a simplified HPV genotyping assay designed for cervical screening in low-resource settings

Analytic performance of ScreenFire HPV RS assay Zebra BioDome format and its potential for large-scale population HPV screening

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