BD 440705 - ProbeTec CT/GC Reagent Pack Advanced Reagents for Molecular Detection of Chlamydia trachomatis and Neisseria gonorrhoeae

BD 440705 - ProbeTec CT/GC Reagent Pack Advanced Reagents for Molecular Detection of Chlamydia trachomatis and Neisseria gonorrhoeae

The BD 440705 ProbeTec CT/GC Reagent Pack is a high-performance reagent system designed for use with the BD ProbeTec ET instrument in the molecular detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC). This reagent pack supports strand displacement amplification (SDA) technology, delivering accurate, rapid, and reliable detection of CT and GC DNA directly from clinical specimens. Optimized for sensitivity and specificity, BDs ProbeTec system provides efficient, automated testing for sexually transmitted infection (STI) diagnostics, ensuring consistent results for high-throughput laboratory operations.

Key Benefits

The BD 440705 ProbeTec CT/GC Reagent Pack offers a combination of precision, speed, and convenience in molecular diagnostics. Its advanced SDA technology enables direct amplification without the need for complex thermal cycling, reducing turnaround time while maintaining high analytical sensitivity. The pre-formulated, ready-to-use reagents minimize human error and handling time, enhancing workflow efficiency. Designed for the BD ProbeTec ET System, this reagent pack ensures consistent performance across multiple runs, making it ideal for routine STI screening in clinical laboratories.

Compatibility and Applications

This reagent pack is specifically designed for use with the BD ProbeTec ET System and is compatible with validated collection devices and specimen types, including endocervical swabs, urine samples, and urethral swabs. It is intended for use in diagnostic laboratories, public health centers, and hospitals for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA. The test aids clinicians in identifying infections, guiding appropriate treatment, and supporting public health surveillance programs aimed at reducing STI prevalence.

Usage Guidelines

Use the BD 440705 ProbeTec CT/GC Reagent Pack in accordance with the BD ProbeTec ET System Operators Manual and laboratory standard operating procedures. Allow reagents to reach room temperature before loading. Mix gently to ensure homogeneity and avoid bubble formation. Load the reagents into the instrument as directed, and follow all quality control measures to validate each run. Store the reagent pack at the recommended temperature, typically between 2C and 8C, to preserve reagent stability and effectiveness. Do not freeze.

Certifications, Safety Standards, and Regulatory Approvals

The BD 440705 ProbeTec CT/GC Reagent Pack is FDA-cleared for in vitro diagnostic use and CE-marked for use in the European Union. Manufactured in ISO 13485 and ISO 9001 certified facilities, it adheres to Good Manufacturing Practice (GMP) standards and rigorous quality control protocols. Each batch undergoes potency, stability, and contamination testing to ensure consistent, regulatory-compliant performance in clinical environments.

Comparison with Competitor Products

Unlike traditional culture-based or immunoassay methods, BDs ProbeTec SDA technology offers faster and more sensitive molecular detection without requiring complex PCR equipment. Compared to other nucleic acid amplification tests (NAATs), the BD 440705 reagent pack delivers equivalent or superior sensitivity and specificity while reducing reagent waste and preparation time. Its integrated automation and simple workflow provide a significant advantage over manual molecular assays and competitor systems with longer turnaround times.

Typical User Profile and Application Scenarios

The BD 440705 ProbeTec CT/GC Reagent Pack is used by molecular diagnostic technologists, clinical microbiologists, and laboratory scientists in hospital, public health, and reference laboratories. It is ideal for large-scale STI screening programs, confirmatory testing, and diagnostic workflows requiring rapid, reliable detection of CT and GC. The systems streamlined automation supports high-volume testing with minimal user intervention, making it particularly suited for modern diagnostic laboratories.

Best Practices for Use and Maintenance

Ensure that all reagents are stored, handled, and loaded under aseptic and temperature-controlled conditions. Perform routine instrument maintenance and calibration as outlined in the BD ProbeTec ET System user manual. Always use fresh, unexpired reagents and run appropriate positive and negative controls with each batch. Dispose of all used materials as biohazard waste according to institutional and local regulations. Regularly monitor run logs and quality control data to maintain system accuracy and compliance.

Regulatory and Safety Information

The BD 440705 ProbeTec CT/GC Reagent Pack meets global standards for molecular diagnostic reagents and complies with FDA, CE, and ISO 13485 requirements. It is intended exclusively for in vitro diagnostic use by trained laboratory personnel. The reagents are non-toxic when handled properly but should be managed as potentially infectious material due to the nature of clinical samples. Always use personal protective equipment (PPE) and follow laboratory biosafety guidelines during handling and disposal.

How to Order

To order the BD 440705 ProbeTec CT/GC Reagent Pack, add the product to your cart and complete your purchase securely through CIA Medicals online ordering system. For institutional or bulk order inquiries, contact CIA Medical customer service at (312) 275-5850 or submit your request through the contact form on this page. Our dedicated representatives can assist with product availability, pricing, and additional technical documentation for your laboratory needs.