Collection of the BD SurePath Pap Test with a broom device plus endocervical brush improves disease detection when compared to the broom device alone or the spatula plus endocervical brush combination

Abstract

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.