Objective:Here we examine the diagnostic utility of the US Food And Drug Administration (FDA) approved Spatula + endocervical brush combination for the BD SurePath Pap Test (SPPT) and compare it to SPPT collection with the broom alone or to an off-label combination of broom + EC brush. This question is important due to lingering concerns over the value of EC detection to a satisfactory Pap test.Methods:20,125 SPPT vials were examined for the collection devices contained. The SPPT collection device combinations allowed were: Rovers Cervex-Brush (broom, FDA approved), Medscand Pap Perfect Spatula + Medscand CytoBrush Plus GT (spatula + GT brush, FDA approved) or Rovers Cervex-Brush + Surgipath C-E Brush (broom + CE brush, off label).Results:Examination of SPPT vials revealed 11,130 collected with the broom, 4,687 collected with the spatula + GT brush and 2,921 collected with the broom + CE brush. Absence of an endocervical/transformation zone was seen in 22.86% of broom cases, 13.10% of spatula + GT brush cases (p= 0.00005 vs broom) and 10.17% of broom + CE brush cases (p= 0.00005 vs broom, p= 0.00005 vs spatula + GT brush). Importantly, LSIL detection was: broom 2.99%; spatula + GT brush 2.45% (p= 0.053 vs broom); broom + CE brush 4.18% (p= 0.034 vs broom, p= 0.0001 vs spatula + GT brush).Conclusion:When broom + brush combination is compared to broom alone or to spatula + GT brush, the broom + CE brush combination better sampled the endocervical/transformation zone and increased LSIL detection.

No US Food and Drug Administration-approved method is available to test for human papillomavirus (HPV) DNA in the SurePath liquid-based Papanicolaou (Pap) test (TriPath Care Technologies, Burlington, NC). We compared the performance characteristics of Inform HPV (Ventana Medical Systems, Tucson, AZ) and Hybrid Capture 2 (HC2; Digene, Gaithersburg, MD) using SurePath for collection. The study included samples from 102 women, aged 18 to 60 years, who underwent a SurePath Pap test immediately before colposcopy and cervical biopsy. Each SurePath specimen was processed additionally for Inform HPV and HC2. Performance characteristics were determined by using the cervical biopsy as the "gold standard." The SurePath, Inform HPV, and HC2 correctly identified high-grade squamous intraepithelial lesions (HSILs) in 15 (94%) of 16, 6 (38%) of 16, and 14 (93%) of 15 cases, respectively. When only SurePath samples with a diagnosis of atypical glandular and/or squamous cells were examined, Inform HPV and HC2 correctly identified HSIL in 19 (43%) of 44 and 45 (100%) of 45 cases, respectively. When SurePath is used for collection, Inform HPV lacks sufficient sensitivity to detect HSIL reliably.

No US Food and Drug Administration-approved method is available to test for human papillomavirus (HPV) DNA in the SurePath liquid-based Papanicolaou (Pap) test (TriPath Care Technologies, Burlington, NC). We compared the performance characteristics of Inform HPV (Ventana Medical Systems, Tucson, AZ) and Hybrid Capture 2 (HC2; Digene, Gaithersburg, MD) using SurePath for collection. The study included samples from 102 women, aged 18 to 60 years, who underwent a SurePath Pap test immediately before colposcopy and cervical biopsy. Each SurePath specimen was processed additionally for Inform HPV and HC2. Performance characteristics were determined by using the cervical biopsy as the "gold standard." The SurePath, Inform HPV, and HC2 correctly identified high-grade squamous intraepithelial lesions (HSILs) in 15 (94%) of 16, 6 (38%) of 16, and 14 (93%) of 15 cases, respectively. When only SurePath samples with a diagnosis of atypical glandular and/or squamous cells were examined, Inform HPV and HC2 correctly identified HSIL in 19 (43%) of 44 and 45 (100%) of 45 cases, respectively. When SurePath is used for collection, Inform HPV lacks sufficient sensitivity to detect HSIL reliably.