BD focalpoint slide profiler performance with atypical glandular cells on SurePath Papanicolaou smears

The FocalPoint Slide Profiler is an automated cervical cytology screening system that is approved for primary screening. It identifies up to 25% of slides as requiring No Further Review. However, few studies have evaluated FocalPoint performance with glandular abnormalities.

Sixty-six SurePath Papanicolaou (Pap) tests with a diagnosis of atypical glandular cells were identified. A total of 172 Pap tests with a diagnosis of "endometrial cells present" were included as controls. Follow-up histology was abnormal if diagnosed as high-grade squamous intraepithelial lesions, adenocarcinoma in situ, carcinoma, or complex endometrial hyperplasia. The FocalPoint software ranked each case into 1 of 7 categories: quintiles 1 (high risk) through 5 (low risk), No Further Review, and Process Review.

A total of 215 slides were qualified for review; 38 (57.6%) atypical glandular cells cases were abnormal on follow-up biopsy, and 27 (71.1%) atypical glandular cells with abnormal follow-up qualified for review; no cases were classified No Further Review, and 9 (33%) were ranked in quintile 1. Twenty-three (82.1%) atypical glandular cells with benign follow-up were qualified for review; 3 (11%) cases were classified No Further Review, and 4 (17%) were ranked in quintile 1. There was a statistically significant difference between the ranking of benign atypical glandular cells cases, abnormal atypical glandular cells cases, and control cases (P = .03). However, when collapsed into No Further Review versus all other quintiles, the differences were not significant (P = .20).

The FocalPoint Slide Profiler did not classify glandular lesions with abnormal follow-up in the No Further Review category. However, these cases were not preferentially ranked in quintile 1. FocalPoint-screened slides need to be carefully reviewed for glandular abnormalities, regardless of the quintile ranking.