BD 256066 - Veritor Plus Analyzer, Accurate Testing Results For Influenza A & B, Respiratory Syncytial Virus (RSV), SARS-CoV-2 (COVID-19), 1/EA

The BD 256066 Veritor Plus Analyzer is a highly advanced diagnostic device designed to provide rapid and accurate testing results for infectious diseases such as Influenza A & B, Respiratory Syncytial Virus (RSV), SARS-CoV-2 (COVID-19), and Group A Strep. This portable, easy-to-use analyzer is part of the BD Veritor System and is widely used in clinical and point-of-care settings to deliver fast, reliable, and actionable results. The Veritor Plus Analyzer helps healthcare providers make informed decisions quickly, facilitating efficient patient management and care.

Product Overview and Design Features

• Rapid Results: The BD Veritor Plus Analyzer delivers rapid test results in minutes, reducing the time required for traditional lab-based diagnostics. This is particularly important for infectious disease testing, where timely results can influence treatment decisions and patient management.
• Digital Display: The analyzer features an easy-to-read digital display that shows clear test results, reducing the risk of interpretation errors often associated with manual reading of test strips.
• CLIA-Waived: The Veritor Plus Analyzer is CLIA-waived, meaning it is approved for use in point-of-care testing environments such as clinics, pharmacies, and urgent care centers. This waiver indicates that the analyzer is simple to operate and doesnt require extensive laboratory training.
• Multiple Testing Modes: The device offers two testing modes:
  • Walk Away Mode, which allows for automated testing and reduces hands-on time for staff.
  • Analyze Now Mode, for users who want immediate results after sample preparation.
• Compact and Portable: The compact and portable design makes the analyzer easy to transport between patient rooms or clinical settings, enabling rapid on-site diagnostics.
• Integrated Connectivity: The Veritor Plus Analyzer is equipped with wireless connectivity to securely transmit test results to electronic medical records (EMRs) or laboratory information systems (LIS), facilitating efficient data management and patient tracking.

Intended Use in Medical Settings

The BD Veritor Plus Analyzer is designed for use in a variety of clinical environments, particularly in point-of-care testing settings such as:

• Urgent Care and Emergency Departments: Ideal for providing rapid diagnostic results during acute patient visits, helping to determine the appropriate course of action quickly.
• Clinics and Doctor's Offices: The analyzer can be used in routine patient visits where quick diagnostics are needed, such as for diagnosing flu, strep throat, or COVID-19 infections.
• Pharmacies and Retail Clinics: With its CLIA-waived status, the Veritor Plus Analyzer is often used in pharmacies and retail health clinics to provide accessible and fast diagnostic testing.

Benefits for healthcare professionals:

• Rapid, Accurate Results: The analyzer provides quick and highly accurate results for a range of infectious diseases, enabling clinicians to make fast and informed treatment decisions.
• Ease of Use: The device is user-friendly and requires minimal training, making it suitable for various healthcare settings, including non-laboratory environments.
• Increased Efficiency: With the Walk Away Mode, healthcare professionals can process tests while attending to other tasks, enhancing workflow efficiency.

Certifications, Safety Standards, and Regulatory Approvals

• FDA Approved: The BD Veritor Plus Analyzer is FDA-cleared for diagnosing various infectious diseases, ensuring that it meets stringent safety and efficacy standards.
• CLIA-Waived: The analyzer is classified as CLIA-waived, meaning it is authorized for use in point-of-care settings that meet basic operational requirements, simplifying its adoption in clinics and pharmacies.
• ISO Certified: BD follows ISO 13485 standards for medical device manufacturing, ensuring the products quality and reliability.

Comparison with Other Market Products

Unique Features:

• Dual Testing Modes: The Walk Away Mode enhances the workflow by allowing healthcare providers to perform other tasks while the test runs, while the Analyze Now Mode provides quick results for immediate decision-making.
• Wireless Connectivity: The integrated wireless connectivity allows for seamless communication with health information systems, improving efficiency and accuracy in data recording.

Common User Profile and Typical Scenarios

The BD Veritor Plus Analyzer is commonly used by:

• Healthcare Providers in Primary Care: Doctors and nurses rely on this analyzer to provide rapid diagnostics during routine visits, especially during flu and RSV season or in pandemic settings.
• Urgent Care Centers: Professionals working in urgent care centers use the analyzer to quickly diagnose patients presenting with symptoms of flu, strep, or COVID-19, allowing for immediate treatment.
• Pharmacies and Retail Clinics: Pharmacists and retail health providers use the analyzer to offer convenient and rapid testing services for common infectious diseases.

Typical scenarios include:

• Flu Season Testing: During flu season, the BD Veritor Plus Analyzer is frequently used to diagnose Influenza A and B infections in both clinics and urgent care settings, helping clinicians to differentiate between flu and other respiratory infections.
• COVID-19 Screening: The analyzer plays a key role in COVID-19 screening at point-of-care facilities, offering quick test results to reduce the spread of the virus and facilitate treatment decisions.
• Strep Throat Testing: The analyzer is also used to test for Group A Strep infections, especially in pediatric or primary care settings where strep throat is a common condition.

Best Practices for Using and Maintaining the Product

To ensure the safe and effective use of the BD Veritor Plus Analyzer, follow these best practices:

• Follow the Manufacturers Protocol: Carefully follow the testing procedures as outlined in the product manual to ensure accurate results. Incorrect handling or timing can affect the test's performance.
• Use Only BD Veritor Plus Assays: Ensure that only the compatible BD Veritor Plus Assays are used with the analyzer to guarantee the accuracy and reliability of the test results.
• Regular Calibration: Perform regular calibration checks as recommended by the manufacturer to ensure the analyzers accuracy and functionality.
• Data Connectivity: Ensure that the wireless connectivity is properly configured to transmit test results securely to the necessary systems, reducing manual data entry errors.
• Proper Cleaning and Maintenance: Clean the analyzer regularly according to the manufacturer's guidelines to maintain hygiene and performance in high-volume environments.

By adhering to these best practices, healthcare providers can ensure that the BD Veritor Plus Analyzer delivers reliable and rapid results, enhancing the quality of care in various clinical settings.