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BD Veritor™ System -- Group A Strep
Rapid chromatographic immunoassay for the direct and qualitative detection of Group A Streptococcus antigen from throat swabs of symptomatic patient
Supplier: BD 256040
Alert:
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.
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
Description
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%
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
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. | |
Streptococcal Antigen (Group A) | |
95.4% | |
Rapid chromatographic immunoassay for the direct and qualitative detection of Group A Streptococcus antigen from throat swabs of symptomatic patients | |
30/Pk. |
Waived | |
Throat swabs of symptomatic patients | |
Veritor System, Group A Strep | |
|
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0.957 |
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For in vitro diagnostic use only