Papanicolaou smear screening augmented by a magnified chemiluminescent exam.

OBJECTIVES

Since the adequacy of screening for cervical cancer and pre-cancer with Papanicolaou smear alone has been questioned, a number of adjunctive tests have been evaluated. This study evaluated whether a magnified chemiluminescent visual screening exam can improve cervical screening when performed coincident with cytologic sampling.

METHODS

Patients were evaluated using the Papanicolaou smear, magnified chemiluminescent visual exam (MCE) and colposcopy at 10 study centers. Screening with either Papanicolaou smear alone or in combination with MCE (Pap and MCE), was evaluated using colposcopy directed biopsy as the highest diagnostic standard.

RESULTS

The Papanicolaou smear alone detected 9/29 (31%) of women with significant pathology (cervical neoplasia) on biopsy, whereas the combination of the Pap and MCE detected 24/29 (83%) of the women (P < 0.001). Patients in whom both tests results were negative (negative Pap and MCE) were extremely unlikely to harbor significant pathology (1% of those screened). Pap and MCE was especially helpful in the detection of low grade cervical lesions when compared with the Papanicolaou smear alone.

CONCLUSIONS

These data indicate that MCE enhances the sensitivity of cervical screening. MCE appears to be particularly useful as a triage instrument in women with otherwise negative Papanicolaou smears. Further studies of cost effectiveness of this combined screening protocol using non-colposcopists is warranted.