AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
Overview
The AutoPap 300 QC System is an automated cervical cytology screening device by BD Diagnostics, designed for the analysis of conventionally prepared Papanicolaou (Pap) smear slides. Initially approved for quality control rescreening to identify false negatives, its indications were later expanded to include initial screening. In this capacity, it can identify up to 25% of successfully processed slides as requiring no further human review, while also flagging at least 15% for a second manual review. The system aims to detect evidence of squamous carcinoma, adenocarcinoma, and their usual precursor conditions, and is intended for use by trained cytology laboratory personnel under qualified supervision.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Automated cervical cytology slide analysis
- Identifies slides requiring no further manual review (up to 25%)
- Identifies slides for a second manual review (at least 15%)
- Designed for conventionally prepared Pap smear slides
- Detects squamous carcinoma, adenocarcinoma, and precursor conditions
- Utilizes image processing algorithms and morphometrics (e.g., nuclear and cytoplasmic area, optical density, shape)
- Enhances false-negative detection rate in quality control rescreening
- Assigns a score based on the likelihood of abnormality
Use Cases
- Initial screening of Papanicolaou (Pap) smear slides
- Quality control (QC) rescreening of cervical smears
- Reducing false-negative rates in cervical cytology laboratories
- Assisting trained cytology laboratory personnel in slide review
What Physicians Need to Know
Physicians should recognize that the AutoPap 300 QC System serves as an automated aid in the quality control process of Pap smear screening, improving the detection of potential false negatives. While the system significantly enhances the detection of false negatives, especially for squamous cell lesions, it's important to note that its sensitivity for glandular lesions may be lower, emphasizing the continued necessity of human review. This system helps optimize laboratory workload by identifying slides that require no further review and by enriching the population of slides needing a second manual review. It is intended for use with conventionally prepared Pap smear slides and should be operated by trained cytology laboratory personnel under appropriate supervision.
The AutoPap 300 QC System processes conventionally prepared and stained slides. It integrates into the existing cytology laboratory workflow by identifying slides for human quality control review, thereby complementing manual screening processes. The system assigns a numerical QC score to each slide based on a statistical classifier algorithm, which can then be used to direct cases for manual rescreening. The original AutoPap 300 QC system was later renamed the BD FocalPoint Slide Profiler, indicating its potential evolution or integration into broader BD diagnostic platforms.
Details
| Category | OB/GYN AI, Oncology AI, Pathology AI |
| Pricing | Not publicly available |
| Deployment | On-premise medical device/instrument system |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
1 AI-estimated The AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM received FDA Premarket Approval (PMA) P950009 on September 29, 1995, for quality control rescreening of cervical smears. A subsequent supplement in 1998 expanded its indication for use in initial screening of Papanicolaou (Pap) smear slides, allowing it to identify slides requiring no further manual review or those needing a second manual review. |
| Integrations | |
| EHR | Not specified |
| Specialties | Obstetrics & Gynecology, Pathology |
Ratings & Reviews
Rate AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
Press & Coverage
Videos
Product demos, reviews, and walkthroughs for AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM.
