Technology Forecast: Automated Systems for Pap Smear Analysis

The following was supplied by ECRI, widely recognized as one of the world's most trusted organizations for unbiased, reliable information on healthcare technology. This article is posted through a partnership agreement between ECRI and this site.

Limited evidence suggests that relatively new automated Pap test technologies may improve upon manual screening for cervical cancer. The U.S. Food and Drug Administration has approved automated Pap test systems that support primary screening and QC rescreening functions.

Consolidation and mergers have reduced the number of automated screening system manufacturers. Primary screening devices list for about $450,000 but can be leased based on a per-slide charge of about $3 to $5. Slide preparation systems sell for $55,000 to $195,000, depending on slide-volume capacity. Suppliers of automated slide preparation systems may form closer ties with makers of automated screening systems to promote more completely automated Pap smear testing methods and increase sales of both.

Several large laboratory chains have adopted the automated Pap smear screening systems. Some health insurers may reimburse laboratories for the costs of automated screening. Automated Pap smear screening does not increase costs to the patient beyond normal laboratory fees. However, automated slide preparation can add $15 to $20 to the charges for a conventional Pap smear, resulting in total patient costs of $30 to $40.

ECRI recommends -- In a recent report, ECRI concluded that automated screening systems may be more effective and less costly than manual screening and rescreening for patients at normal risk of cervical cancer, based on limited cost-effectiveness data. Furthermore, an automated screening device can perform both primary screening and QC rescreening. However, ECRI could not determine whether automated Pap smear slide preparation systems were superior to conventional slide preparation based on available evidence. ECRI recommends further studies on automated screening and slide preparation systems under replicated normal laboratory conditions to avoid inflating the performance of the automated systems.