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.