Abstract
BackgroundThe solid transport media is a small size card that allows fast, easy DNA extraction from a variety of biological samples. In 2016 we developed a solid media transport card; for that pilot study to control the self-collection we used a pseudo-self-collection technique. The current study expands this prior work using true self-collections and only the POI card, and aims to evaluate the solid media transport card to detect HR-HPV in self-samples compared to liquid transport media.MethodsTen thousand eight hundred eighty-five women between the ages of 30–59 with no screening for 3 years were enrolled. The self-collected sample was first applied to a new solid media transport card (Labeled as SC) then the brush placed in 6 ml ThinPrep liquid (Labeled as SL). Then a physician collected a direct endocervical specimen into ThinPrep liquid (Labeled as DL). Samples were tested with Cobas 4800 and the SeqHPV NGS assay for HR-HPV. Patients positive on any test were recalled for colposcopy and biopsy.ResultsTen thousand three hundred thirty-nine participants had complete data. The mean age was 43.9 years. CIN 2+ rates were 1.4% (142/10339). The agreement in HPV detection between the two different self-sample collection media was also good (Cobas HPV kappa = 0.86; SeqHPV kappa = 0.98). Tested with Cobas, the sensitivity of Cobas-SL and Cobas-SC for CIN 2+ was95.07 and 94.37%; and for CIN3+ was 96.30, 96.30% respectively. The specificity of Cobas-SC, and Cobas-SL for CIN2+ was 88.74 and 87.35%; for CIN3 was 88.04and 86.65% respectively. Tested with SeqHPV, the sensitivity for CIN2+ of Seq-SC and Seq-SL was 95.77 and 96.48%; for CIN3+, both the SC and SL specimens had a sensitivity of 100%. The specificity for CIN2+ of Seq-SC and Seq-SL was 89.54 and 89.53%; for CIN3+ was 88.84,88.82% respectively. For both HR-HPV assays, the sensitivities were similar for the two self-sample media (SC vs SL, p = 1.00).ConclusionsThe solid transport card for collecting vaginal self-samples as accurate as liquid transport media assayed by two different PCR based HR-HPV tests. The solid transport media is a suitable medium for collecting and storing vaginal self-samples.
Highlights
Cervical swabs have been placed in liquid media for transport
The solid transport card for collecting vaginal self-samples as accurate as liquid transport media assayed by two different PCR based HR-HPV tests
The return rate for colposcopy was 81.0%. 1.4% (141 patients) had CIN2+ and 0.5% had CIN3 + .101 (0.93%) women were dropped from the analysis due to HPV test failure. 6 (0.05%), 2 (0.02%), 29 (0.27%),34 (0.31%), 19 (0.17), and 19 (0.17) were missing Cobas-DL, Cobas-SL, Cobas-SC, Seq HPV-DL, SeqHPV-SL and SeqHPV-SC, respectively
Summary
Due to the logistical difficulties such as spillage, flammability, and weight, adding to the risks and costs of liquid transport media, solid carriers consisting of chemically treated or untreated filter paper have been investigated for hrHPV testing These filter paper cards are easy and safe to store and transport [1,2,3,4,5,6,7,8,9,10,11,12,13]. In a sub study (Luo et al.) provides data to suggest the iFTA may be a poorer transport vehicle than the new card when combined with the Cobas assay [15] In this trial we will evaluate the recently validated POI card for detecting HR-HPV in vaginal self-samples compared to self-collected samples transported in the standard PreservCyt liquid. The current study expands this prior work using true selfcollections and only the POI card, and aims to evaluate the solid media transport card to detect HR-HPV in selfsamples compared to liquid transport media
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