Clarity Diagnostics Clarity Strep A Test Kit (25/Box)

Yes, the Clarity Strep A Test Kit is a rapid immunoassay designed for the prompt detection of Group A Streptococcal antigen directly from throat swab specimens. This facilitates quick clinical decision-making regarding potential Strep A infections.

Key Features for Rapid Use

• CLIA Waived Status: Suitable for use in less complex testing environments, like doctor’s offices.
• Convenient Format: Supplied as individually pouched flip cassettes for ease of handling.
• Storage: Supports room temperature storage, simplifying logistics.

Note: This is strictly for prescription use. All negative results obtained from this rapid test must be confirmed by bacterial culture to conclusively rule out a Group A Strep infection.

Yes, the Clarity Strep A Test Kit includes the necessary controls in the box.

Using these controls is essential for clinical practice to:

• Ensure reagent integrity.
• Validate the accuracy and reliability of the testing procedure.

Yes, the Clarity Strep A Test Kit is supplied with 25 individually pouched flip cassettes per box. This packaging design ensures maximum integrity and convenience for clinical use:

• Protection: Each cassette is sealed and protected until the moment of use, which helps prevent contamination and maintains the product’s integrity.
• Convenience: Facilitates easy and efficient handling and dispensing, making it ideal for point-of-care diagnosis.

The Clarity Diagnostics Clarity Strep A Test Kit includes all necessary components for rapid, CLIA-waived diagnostic testing, packaged in a convenient 25-test format. This streamlines testing procedures in a professional setting.

Each box contains:

• 25 Clarity Strep A Flip Rapid Test Cassettes: These are individually pouched flip cassettes designed for the rapid detection of Group A Streptococcal antigen directly from throat swab specimens.
• Necessary Controls: Controls required for quality assurance and valid test operation are included in the kit.

Yes, the Clarity Strep A Test Kit is strictly available for prescription use and is intended only for professional in vitro diagnostics.

It is designed to be administered by qualified medical professionals in various clinical settings, including doctors’ offices, hospitals, and laboratories. Notably, this test is CLIA Waived, allowing for its use in diverse point-of-care environments.

Yes, the Clarity Strep A Test Kit is a complete diagnostic kit that includes the necessary controls directly within the box. This feature is crucial for verifying the test’s performance, ensuring immediate usability, and supporting accurate in vitro diagnostic results.

Yes, the Clarity Strep A Test Kit is specifically designed for in vitro diagnostic use, detecting Group A Streptococcal antigen directly from throat swab specimens taken from symptomatic patients.

As a CLIA Waived rapid immunoassay, it provides quick results for timely diagnosis and is suitable for deployment in various healthcare environments, including point-of-care clinical settings.

Yes, this test kit is CLIA Waived, making it suitable for deployment in a wide variety of clinical environments, including doctors’ offices and point-of-care locations. These settings commonly include:

• Doctors’ offices
• Hospitals
• Outpatient clinics and primary care settings
• Clinical laboratories

This product is strictly for in vitro diagnostic use and is available only by prescription.

The Clarity Strep A Test Kit is designed for convenient storage at room temperature. This simplifies handling and logistics as it eliminates the need for refrigeration or specialized cold chain requirements.

Yes, the Clarity Strep A Test Kit is strictly intended for professional use in clinical settings and is available for prescription use only.

• Intended Use: It is designed for in vitro diagnostic use to quickly identify Strep A germs from throat swabs of symptomatic patients.
• Appropriate Settings: This kit is used in professional medical environments, including doctors’ offices, hospitals, and clinical laboratories.