Self-Collected HPV Test Results Are as Accurate as Clinic-Collected Results

In the IMPROVE study conducted by Polman and colleagues and published in THE LANCET Oncology, self-collected cervical (cervix) samples showed, for HPV positivity and HPV-related cervical intraepithelial neoplasia (CIN 2 or CIN3) lesions, sensitivity and accuracy similar to samples collected during a doctor’s examination.

Study Details

Women aged 29 to 61 were invited to participate as part of regular Dutch cancer screening . Participants were randomly divided equally into two arms: one used Evalyn Brush for self-collection of cervicovaginal samples; in the other, a physician used Cervex-Brush as usual.

All samples were tested for HPV using clinically validated GP5+/6+ polymerase chain reaction (PCR) . Women testing positive in either group were retested using the other collection method.

The figure below illustrates the pathological process from HPV infection to cervical cancer . CIN stands for cervical intraepithelial neoplasia and ranges from 1 to 3; increasing numbers indicate a greater proportion of dysplastic cells. CIN is not cancer and does not necessarily become cancer, but these lesions have cancerous potential (precancerous).

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The primary endpoints were detecting CIN2 and CIN3 positivity. Noninferiority (not being a weaker test) criteria for self-collected versus physician-collected samples were set at % 90 relative sensitivity and % 98 relative specificity.

Study Results

• Among 187.473 women invited, 8.212 were assigned to self-sampling and 8.198 to physician-based sampling. After excluding ineligible women and non-returned samples, the self-sampling group included 7.643 and physician-based sampling 6.282 women.
• HPV positivity was detected in 569 (%7.4) self-collected samples and 451 (%7.2) physician-collected samples.
• Median follow-up for HPV-positive women was 20 months.
• No difference in sensitivity or accuracy (specificity) was observed between physician and self-sampling HPV tests for CIN2 positivity. Similarly, no difference was observed for CIN3 positivity.

In conclusion, HPV testing using a clinically validated PCR-based test had similar accuracy in self-collected and physician-collected samples for CIN2 + or CIN3 + lesions. These findings suggest self-sampling could be used as a primary method in routine screening.

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