An evaluation of solid versus liquid transport media for high-risk HPV detection and cervical cancer screening on self-collected specimens

摘要

The 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. Ten 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. Ten 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). 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 solid transport media is a suitable medium for collecting and storing vaginal self-samples.