BD Veritor™ System -- Group A Strep

Description

Includes

• BD Veritor System Group A Strep Device (30 devices): Foil pouched device containing one reactive strip. Each strip has one test line of polyclonal antibody specific to Strep A antigen and a positive control line containing purified Strep A antigen
• BD GAS Reagent 1 (Bottle with 4mL reagent): Dilute acetic acid solution
• BD GAS Reagent 2: (30 tubes with 200μL reagent): Sodium nitrite and EDTA
• Individually packaged sterile swabs (30 each): for throat specimen collection
• Positive Control Swab (1 each): Strep A Positive Control Swab (purified Strep A antigen) with <0.1% sodium azide (preservative)
• Negative Control Swab (1 each): Strep A Negative Control Swab with <0.1% sodium azide

Rapid chromatographic immunoassay for the direct and qualitative detection of Group A Streptococcus antigen from throat swabs of symptomatic patient

The first CLIA-waived Digital Immunoassay (DIA), a new category of diagnostic tests where the assay and instrument work together to combine advances in detection particles, optical image recognition and interpretation algorithms to improve accuracy.

• For use in point-of-care or laboratory settings
• Provides greater consistency regardless of user's experience
• Provides digital and reliable result in minutes
• High sensitivity and specificity performance
• Test utilizes antibodies specific for whole cell Lancefield group A Streptococcus to selectively detect Strep A antigen
• Easy sample processing; unitized tube containing the correct volume of process reagent facilitates workflow; just add 3 drops of reagent 1 and incubate for 1 to 2 min.
• Test device is ready to insert into reader in 5 minutes after sample is added
• Simple one-touch button readies the reader for test device insertion
• Digital test result is displayed in 10 seconds
• Sensitivity: 95.4%
• Specificity: 95.7%

Note:

All negative test results should be confirmed by bacterial culture because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment.

Recommended Storage

Store kits at 2° to 30°C. Do not freeze. Reagents and devices must be at room temperature between 15° to 30°C) when used for testing.

Specifications

• Content And Storage: Store kits at 2°C to 30°C. Do not freeze. Reagents and devices must be at room temperature between 15°C to 30°C when used for testing.
• Clia Complexity: Waived
• Detectable Analytes: Streptococcal Antigen (Group A)
• Sample Type: Throat swabs of symptomatic patients
• Sensitivity: 95.4%
• Type: Veritor System, Group A Strep
• For Use With (Application): Rapid chromatographic immunoassay for the direct and qualitative detection of Group A Streptococcus antigen from throat swabs of symptomatic patients
• Includes:
  • BD Veritor System Group A Strep Devices (30 devices): Foil pouched device containing one reactive strip. Each strip has one test line of polyclonal antibody specific to Strep A antigen and a positive control line containing purified Strep A antigen
  • BD GAS Reagent 1 (Bottle with 4mL reagent): Dilute acetic acid solution
  • BD GAS Reagent 2: (30 tubes with 200μL reagent): Sodium nitrite and EDTA
  • Individually packaged sterile swabs (30 each): for throat specimen collection
  • Positive Control Swab (1 each): Strep A Positive Control Swab (purified Strep A antigen) with <0.1% sodium azide (preservative)
  • Negative Control Swab (1 each): Strep A Negative Control Swab with <0.1% sodium azide
• Quantity: 30/Pk.
• Specificity: 0.957

For in vitro diagnostic use only