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

Catalog No. B256040

$376.10 / Pack of 30 Each

Quantity

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%

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 2Â° to 30Â°C. Do not freeze. Reagents and devices must be at room temperature between 15Â° to 30Â°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.
Detectable Analytes	Streptococcal Antigen (Group A)
Sensitivity	95.4%
For Use With (Application)	Rapid chromatographic immunoassay for the direct and qualitative detection of Group A Streptococcus antigen from throat swabs of symptomatic patients
Quantity	30/Pk.

Clia Complexity	Waived
Sample Type	Throat swabs of symptomatic patients
Type	Veritor System, Group A Strep
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
Specificity	0.957

For in vitro diagnostic use only

BD Veritor™ System -- Group A Strep

Alert:

Description

Recommended Storage

Specifications

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