Abstract
ObjectiveThe aim of this research was to evaluate independently the performance of a new isothermal amplification assay for cervical cancer screening compared to two previously validated PCR-based assays and histologic endpoints.MethodsThis is a sub-study from the Chinese multi-center screening trial (CHIMUST). The self-collected and clinician-collected specimens stored in PreservCyt at − 4 °C from 6042 women with complete data were tested with the AmpFire assay. These specimens had been previously tested with Cobas and SeqHPV assays. In the primary study all patients with an abnormal test were referred to colposcopy where all had directed and/or random biopsies plus ECC. No additional patients were called back based on the AmpFire results.Results6042/6619 women had complete data (mean age 44.1). There were 57 cases of CIN 2, 35 cases of CIN 3 and 2 cancers. The sensitivity for CIN2+ and CIN3+ were similar among the three assays (both direct and self-collected). For the specificities in all categories (CIN2+/CIN3+ and self and direct collection), isothermal amplification assay was either equal to or more specific than Cobas but consistently less specific than SeqHPV.ConclusionThe AmpFire HPV assay showed similar sensitivity to Cobas and SeqHPV for CIN2+ and CIN3+ on both self and clinician-collections (P>0.05), with good specificity. The speed, low cost, and simplicity of this assay will make it particularly suited for low and middle resource settings. Its accuracy with self-collection makes it applicable for mass screening programs.
Highlights
For over two decades, our academic research group has had a major interest in self-collection technologies for cervical cancer screening [1]
We learned of the AmpFire assay which presented a unique constellation of characteristics that appeared special among the sea of high-risk human papillomavirus assays we had explored over the years
The mean age of the study population (6042) was 44.1 years. 577 (8.7%) women were dropped from the analysis: 1501 women were asked to return for colposcopy, and 556 (37.04%, 556/ 1501) did not return to the study doctors. 6 (0.09%, 6/ 6619) were missing Cobas human papillomavirus (HPV) clinician collection data; 1 (0.02%, 1/6619) was missing SeqHPV clinician data; 10 (0.15%, 10/6619) were missing SeqHPV self-collection results (1 of the these missing AmpFire self-collection); and 4 (0.06%, 4/6619) had unsatisfactory cytology
Summary
Our academic research group has had a major interest in self-collection technologies for cervical cancer screening [1]. With the simplicity came a significant reduction in per sample cost, as well as the equipment and space required, equal to the least expensive of HPV assays. We saw a future opportunity to use a simple dry collection brush with no transport media required (solid or liquid). This would further reduce the cost and facilitate population-based screening in remote communities. The combination of these unique features represented a real opportunity to integrate clinicbased hrHPV testing into same-day “test-and-treat” cervical screening programs. The objective of this study was to compare the AmpFire high-risk HPV assay to two previously validated PCR-based assays, using histologic endpoints
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