A self-collected vaginal human papillomavirus test demonstrated 95.8% sensitivity for detecting high-grade cervical dysplasia, matching clinician-collected results in a large U.S. trial, according to a recent study.
In a nonrandomized clinical trial, researchers evaluated a vaginal self-collection (SC) device designed for at-home cervical cancer screening using high-risk (hr) HPV testing. Conducted across 16 clinical sites in the United States from November 2023 to April 2024, the researchers enrolled 599 participants aged 25 to 65 years. Each participant collected an SC sample in a simulated home environment, followed by a clinician-collected (CC) sample for method comparison. Both samples were tested using the U.S. Food and Drug Administration–approved Roche cobas hrHPV assay after SC specimens were eluted from dry storage into PreservCyt media at the laboratory.
Agreement between SC and CC samples for detection of hrHPV was the primary outcome measure. Among 582 valid paired samples, the positive percentage agreement for hrHPV was 95.2% (278/292). Agreement for HPV-16 and HPV-18 genotypes was 95.8% (69/72). The SC method demonstrated an absolute clinical sensitivity of 95.8% (46/48) for high-grade cervical dysplasia (CIN2+), matching the CC sample sensitivity (relative sensitivity = 1.00). For CIN3+, the SC sensitivity was 96.6% (28/29), with a relative sensitivity of 0.97.
The rate of invalid SC results was 2.3% (14/599), comparable to 0.5% (3/599) with CC. Usability surveys indicated that 92.3% of participants (555/601) found the SC instructions easy or very easy to follow, and 93.0% (560/602) would choose SC if results were equivalent to CC. Adverse events attributable to the SC device occurred in 0.3% (2/602), and were mild.
The researchers concluded that the SC method demonstrated high agreement and equivalent sensitivity compared with clinician sampling, while offering a safe and preferred approach for cervical cancer screening. The findings supported the use of at-home SC testing as a viable strategy to improve screening accessibility and uptake among underscreened populations.
Full disclosures can be found in the published study.
Source: JAMA Network Open
