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

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.