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BD Veritor™ System -- Group A Strep

Catalog No. B256040
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30/Pk.
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B256040 30/Pk.
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GAS Reagent 1 may cause skin, eye and respiratory tract irritation. The combination of GAS Reagent 1 and Gas Reagent 2 generates nitrous acid which may cause skin, eye and respiratory tract irritation.
Catalog No. B256040 Supplier BD Supplier No. 256040
GAS Reagent 1 may cause skin, eye and respiratory tract irritation. The combination of GAS Reagent 1 and Gas Reagent 2 generates nitrous acid which may cause skin, eye and respiratory tract irritation.

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 Streptococci (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