Original Article
The accuracy and validity of HPV testing through self-collection with tampons for cervical cancer screening
Abstract
Background: Detection of HPV DNA using a self-collection kit in the home setting could provide a simple, less-invasive method for cervical cancer screening. In this feasibility study, we examined the rates of HPV DNA detection with tampons collected at home as compared to clinician obtained cervical swabs.
Methods: A total of 120 participants were recruited by street outreach and letters and randomly assigned to either a Self-collection Arm or a Clinic Arm. Participants in the Self-collection Arm collected the sample at home using a tampon, followed by a clinic visit for Pap testing with clinician-sampling via cervical swab and pelvic examination. Participants in the Clinic Arm had a clinic visit for Pap testing with clinician-sampling via cervical swab and pelvic examination. Both home samples and clinician obtained cervical samples were tested for HPV DNA and the sensitivity and specificity of HPV testing via tampon with samples collected in the home were calculated.
Results: The percentage of tampon samples returned was 80.0% (48/60), which was significantly higher than attending of clinic visits (56.7%, 34/60). A valid HPV test was seen more often in clinician-obtained samples (34/34, 100%) as compared to self-collected samples (35/48, 72.9%). Logistic regression showed that invalid HPV testing may be related to longer interval between sample collection to sample receipt (P=0.08) but this did not reach statistical significance. However, there was no difference in the detection rates between the two Arms (58.3% vs. 56.7%) if only adequately collected samples were compared. Only 23 subjects
in the Self-collection Arm had both the tampon sample and clinic sample collected, and HPV testing from the self-colleced samples showed high sensitivity (100%) and specificity (94.1%) as compared to any HPV positive results with clinic sample as the reference test.
Conclusions: When collected and transported properly, self-collection with a tampon compared favorably to a clinical-obtained cervical swab for HPV testing. While home sampling for HPV could be an alternative to clinic-based testing for hard to reach women, more research is needed to improve the validity of HPV testing with the self-collected tampon sample.
Methods: A total of 120 participants were recruited by street outreach and letters and randomly assigned to either a Self-collection Arm or a Clinic Arm. Participants in the Self-collection Arm collected the sample at home using a tampon, followed by a clinic visit for Pap testing with clinician-sampling via cervical swab and pelvic examination. Participants in the Clinic Arm had a clinic visit for Pap testing with clinician-sampling via cervical swab and pelvic examination. Both home samples and clinician obtained cervical samples were tested for HPV DNA and the sensitivity and specificity of HPV testing via tampon with samples collected in the home were calculated.
Results: The percentage of tampon samples returned was 80.0% (48/60), which was significantly higher than attending of clinic visits (56.7%, 34/60). A valid HPV test was seen more often in clinician-obtained samples (34/34, 100%) as compared to self-collected samples (35/48, 72.9%). Logistic regression showed that invalid HPV testing may be related to longer interval between sample collection to sample receipt (P=0.08) but this did not reach statistical significance. However, there was no difference in the detection rates between the two Arms (58.3% vs. 56.7%) if only adequately collected samples were compared. Only 23 subjects
in the Self-collection Arm had both the tampon sample and clinic sample collected, and HPV testing from the self-colleced samples showed high sensitivity (100%) and specificity (94.1%) as compared to any HPV positive results with clinic sample as the reference test.
Conclusions: When collected and transported properly, self-collection with a tampon compared favorably to a clinical-obtained cervical swab for HPV testing. While home sampling for HPV could be an alternative to clinic-based testing for hard to reach women, more research is needed to improve the validity of HPV testing with the self-collected tampon sample.
