The MonoPrep Pap test for the detection of cervical cancer and its precursors. Part I: results of a multicenter clinical trial.
The MonoPrep Pap Test (MPPT; MonoGen, Lincolnshire, IL) is a novel, liquid-based specimen collection and processing technology for cytologic and molecular testing. Its usefulness in the detection of cervical cancer and its precursors was evaluated in a multicenter, masked, adjudicated, split-sample study of 10,739 samples. After preparation of a conventional smear, the residuum on the collection device was rinsed into a collection vial from which an MPPT slide was prepared. Accuracy was assessed by masked reference interpretation by an independent pathologist. Slides prepared by MPPT, compared with smears, yielded statistically significant increases in relative sensitivity for atypical squamous cells of undetermined significance and worse, atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion/atypical glandular cells and worse, and low-grade squamous intraepithelial lesion and worse. There was no significant difference in relative specificity. MPPT provided a 58% reduction in unsatisfactory slides. There was no significant difference in the presentation of endocervical/transformation zone component or the detection of benign conditions. The MPPT is a promising new liquid-based technology for cervical cancer screening.
Cibas
Edmund S
ES
Department of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02115, USA.
Alonzo
Todd A
TA
Austin
R Marshall
RM
Bolick
David R
DR
Glant
Michael D
MD
Henry
Michael R
MR
Moriarty
Ann T
AT
Molina
J Thomas
JT
Rushing
Lynda
L
Slowman
Sally D
SD
Torno
Roosevelt
R
Eisenhut
Carol C
CC
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005188:False Negative Reactions; D005260:Female; D006801:Humans; D008875:Middle Aged; D011230:Precancerous Conditions / Q000175:diagnosis / Q000517:prevention & control; D013048:Specimen Handling; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D014626:Vaginal Smears / Q000379:methods*