Table 4. Summary of technical challenges and opportunities for HPV testing globally.
| Challenges | Opportunities |
|---|---|
| Sample collection | |
| • Collection devices and collection media are not standardized and validation of existing products across different testing platforms is limited • Proprietary devices optimized for sample collection are costly • Generic devices may increase complexity of lab processes • Liquid cytology media is too toxic to send into homes, incompatible with some platforms, has high cost and lab complexity • Liquid molecular buffers leave samples more susceptible to degradation in transit, have relatively high cost, and restrict sample usage to certain testing platforms • Dry swab collection leaves samples most susceptible to degradation in transit, risking false negatives |
• Standardize a common buffer or sample type across existing HPV testing platforms • Expand validation studies of a wide range of buffers or sample types across platforms • Validate dry swab stability and clinical sensitivity for high-grade disease across HPV testing platforms |
| Point-of-care tests | |
| • HPV tests on the market remain too complex for true point-of-care use |
• Expand near-patient or point-of-care testing approaches • Innovate true point-of-care testing platforms, especially leveraging recent SARS-CoV-2 rapid molecular tests |
| Increasing access with self-collection | |
| • Self-collected samples need to be transported from the screening participant to the lab • Results need to be communicated back to the screening participant with appropriate linkages to follow-up care • Technical challenges with processing vaginal instead of cervical samples • Cut points and limits of detection may not be optimal for dry swabs • Trained personnel are needed to support self-collection and follow-up |
• Increase dry swab stability for transport • Adjust lab protocols for vaginal sample processing • Optimize test characteristics for compatibility with dry swabs • Characterize dry swab stability through multiple modes of transport • Integrate quality control indicators into samples and/or tests |
| Clinical role of triage tests | |
| • HPV DNA tests have low positive predictive values • Resource constraints dictate triage test used |
• Investigate clinical role of extended HPV genotype-based risk stratification and other single-test strategies for screening and triage • Evaluate clinical performance of recent cervical imaging innovations |
| Access to regulatory support and funding | |
| • Many HPV tests on the market are not appropriately validated • Clinical evaluations of HPV tests employ variable study designs and sample types |
• Create a standardized and well-validated set of reference samples |
| Impacts of the COVID-19 pandemic | |
| • People have inadequate access to affordable and suitable HPV testing platforms globally • Technology developed to mitigate the COVID-19 pandemic have exacerbated global health inequities |
• Develop regional approval processes to facilitate access to new technologies • Leverage innovations for SARS-CoV-2 molecular detection to develop new HPV tests • Utilize centralized COVID-19 testing infrastructure for HPV testing • Implement decentralized sampling strategies, including at-home self-collection |
| Procurement | |
| • Per-test costs remain too high for widespread use without negotiated bulk pricing in LMICs • Many distinct and overlapping funding efforts are involved in test platform and consumables procurement |
• Develop national essential diagnostics lists to integrate procurement at the governmental level • Organize a procurement and coordination effort, subsidized cartridges, and/or reagents for existing multi-analyte platforms |