BD 440450 - ProbeTec CT/GC/AC Reagent Kit, 384 Tests, for Molecular Detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis,EA
The BD 440450 - BD ProbeTec CT/GC/AC Reagent Kit is a high-performance molecular diagnostic reagent system designed for the simultaneous detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and Trichomonas vaginalis (AC) using BDs advanced strand displacement amplification (SDA) technology. This kit provides all the necessary reagents to process up to 384 patient specimens on BDs ProbeTec molecular platforms, offering rapid, accurate, and reliable identification of common sexually transmitted infections (STIs).
Manufactured by Becton Dickinson (BD), the ProbeTec CT/GC/AC assay has become a benchmark for molecular STI diagnostics, delivering high sensitivity, specificity, and workflow efficiency in clinical and public health laboratories. Its automated assay process minimizes human error, reduces turnaround times, and enhances the reliability of STI screening and confirmatory testing.
Key Benefits
The BD ProbeTec CT/GC/AC 384 Test Kit offers exceptional accuracy and operational efficiency, ensuring dependable results for clinicians and laboratories. Its key benefits include:
- High sensitivity and specificity: Detects low levels of CT, GC, and AC DNA in a single test, reducing false negatives and false positives.
- Multiplex testing efficiency: Enables simultaneous detection of three pathogens from one specimen, saving time and resources.
- Streamlined workflow: Designed for use with BDs automated molecular platforms to improve throughput and consistency.
- Closed-system safety: Reduces contamination risk through automated sample handling and sealed reagent cartridges.
- Validated performance: Proven accuracy in large-scale clinical studies for routine diagnostic and epidemiological testing.
This reagent kit supports large-volume laboratories performing high-throughput STI screening and diagnostic confirmation.
Compatibility and Applications
The BD 440450 ProbeTec CT/GC/AC Reagent Kit is compatible with the following BD molecular diagnostic platforms:
- BD Viper System with XTR Technology
- BD ProbeTec ET System
It is designed for testing endocervical, urethral, vaginal, and urine specimens collected using BD ProbeTec Collection Kits. Common applications include:
- Screening for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in clinical specimens.
- Diagnostic testing in sexual health, obstetrics, gynecology, and urology clinics.
- Public health surveillance and research on STI prevalence and co-infection rates.
The kit is optimized for laboratories processing medium to high specimen volumes and seeking rapid, reliable molecular detection of multiple STIs from a single sample.
Usage Guidelines
Follow the BD ProbeTec system operators manual for correct setup and reagent preparation. Load the reagent strips, amplification tubes, and control reagents according to kit instructions. Use appropriate BD collection kits for sample acquisition and transfer specimens into the testing platform using aseptic technique. Ensure proper calibration and run internal controls for each batch. Store the reagent kit at 28C and avoid repeated freeze-thaw cycles. Dispose of all biological waste according to institutional biosafety protocols.
Certifications, Safety Standards, and Regulatory Approvals
The BD ProbeTec CT/GC/AC Reagent Kit is FDA-cleared and CE-marked for in vitro diagnostic (IVD) use. It is manufactured in accordance with ISO 13485:2016-certified quality management systems and complies with CLSI and WHO molecular testing standards. Each batch undergoes extensive validation for accuracy, precision, and sensitivity using reference control materials. BDs rigorous quality assurance processes ensure consistency and reliability for clinical and epidemiological testing worldwide.
Comparison with Competitor Products
Compared to other molecular STI diagnostic kits, such as those from Roche or Hologic, the BD ProbeTec CT/GC/AC Kit provides excellent workflow flexibility and cost efficiency. While competitor platforms often require separate tests for each pathogen, BDs multiplex SDA technology enables simultaneous detection of three major STIs in a single assay. The closed-cartridge system minimizes contamination risks and reduces manual handling. Laboratories also benefit from BDs broad range of compatible collection devices and integrated software for result tracking and reporting.
Typical User Profile and Application Scenarios
This product is designed for use by trained laboratory technologists, molecular diagnostics professionals, and microbiologists in clinical and public health laboratories. Typical scenarios include:
- Routine STI screening in sexual health and reproductive care clinics.
- Confirmatory testing for symptomatic patients or contact tracing.
- Population-level surveillance of antimicrobial resistance trends in STIs.
- Academic or clinical research on STI co-infections and molecular epidemiology.
The BD 440450 kit is ideal for high-volume facilities seeking standardized, automated, and high-sensitivity STI testing solutions.
Best Practices for Use and Maintenance
Store reagents at 28C in original, sealed packaging until use. Do not expose to direct light or extreme temperatures. Mix reagents gently before loading; avoid creating bubbles that can affect accuracy. Use within the expiration date indicated on the label. Always run internal controls (positive and negative) with each batch to ensure reagent performance. Perform routine maintenance of BD ProbeTec instruments as per manufacturers instructions to maintain optimal assay reliability. Dispose of all biohazard materials following local and institutional regulations.
Regulatory and Safety Information
The BD 440450 - BD ProbeTec CT/GC/AC Reagent Kit is an FDA-cleared, CE-marked in vitro diagnostic reagent kit intended for professional laboratory use only. It complies with ISO, CLSI, and GMP standards for molecular diagnostics. The reagents are non-toxic, non-pyrogenic, and formulated with proprietary nucleic acid amplification components. A Safety Data Sheet (SDS) is available from BD upon request, detailing reagent composition, handling precautions, and disposal instructions. This product should be used only by trained professionals familiar with molecular diagnostic techniques and biosafety practices.
How to Order
To order the BD 440450 - BD ProbeTec CT/GC/AC Reagent Kit (384 Tests), add the item to your cart and complete checkout through CIA Medical. We offer competitive pricing, reliable delivery, and dedicated customer support for diagnostic and research laboratories. For bulk purchases, technical documentation, or assistance with assay integration, contact CIA Medicals customer service at (312) 275-5850 or use the contact form on this page. Our team can provide additional guidance on product availability, validation data, and compatibility with your existing BD molecular systems.
