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
Manufacturer: BD 256040
DescriptionThe 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.
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.
|BD Veritor System Reader|
|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.|
|Rapid chromatographic immunoassay for the direct and qualitative detection of Group A Streptococcus antigen from throat swabs of symptomatic patients|
|Veritor System, Group A Strep|
|Throat swabs of symptomatic patients|
|Group A Streptococcus|
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For in vitro diagnostic use only