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The BBL™ Streptocard™ Enzyme Latex Test is a latex test system for the qualitative identification of Lancefield streptococcal groups A, B, C, D, F and G.

Lancefield¹ showed that the majority of pathogenic streptococci possess specific carbohydrate antigens, which permit the classification of streptococci into groups. These streptococcal group antigens are extracted from the streptococcal cell wall in a liquid form, and reacted with group specific antibodies.

Quality control requirements must be performed in accordance with applicable local, and/or federal regulations or accredition requirements and your laboratory's standard Quality Control procedures. It is recommended that the user refer to pertinent CLSI guidance and CLIA regulations for appropriate Quality Control practicies. Initially, upon receipt, the laboratory should check each shipment or lot of material prior to use to verify the performance of the product.

Streptococci of known group reactivity should be subjected to the complete test procedure. The performance of the test is assessed by the presence of agglutination in one latex suspension only, with the other five suspensions showing a negative (no agglutination) reaction for each reference strain tested. This will evaluate both the efficiency of the extraction procedure and the specificity of each reagent.

The positive control procedure and negative control procedure should be tested each day of use. Local, regional, or other laboratory regulations may apply which supersede package insert directions for frequency of testing the positive and/or negative control.

POSITIVE CONTROL - Shake each Test Latex and dispense 1 drop onto a separate circle on the card. Dispense 1 drop of Control + onto each of six circles. Spread each mixture over the entire area of the circle, using a separate stick for each Test Latex. Rock the card manually for 1 min. Each of the six Test Latex should demonstrate obvious agglutination.

NEGATIVE CONTROL - Shake each Test Latex and dispense 1 drop onto a separate circle on the card. Dispense 1 drop of reconstituted BBL Extraction Enzyme onto each of the six circles. Spread each mixture over the entire area of the circle, using a separate stick for each Test Latex. Rock the card manually for 1 min. No obvious agglutination should be evident for any Test Latex suspension.

The BBL™ Streptocard™ Positive Control (Cat. No. 240965) contains a mixture of extracted antigen from streptococcal groups A, B, C, D, F and G with sodium azide as a preservative. This control may also be used to perform quality control when using the individual test latex reagents (see "Availability").

For in vitro Diagnostic Use.

Caution: This product contains natural rubber latex which may cause allergic reactions.

Do not use test components beyond the expiration date.

Do not allow reagents to become contaminated by allowing the dropper tip to touch the specimen on the reaction card. Ensure caps are securely fitted on reagent bottles after each use to prevent contamination and drying out of the reagents.

WARNING: Extraction Enzyme contains Mercury. Don't put in trash. Recycle or dispose as hazardous waste.

Reagents contain sodium azide. Very toxic by inhalation, in contact with skin, and if swallowed. Contact with acids liberates very toxic gas. After contact with skin, wash immediately with plenty of water. Sodium azide may react with lead and copper plumbing to form highly explosive metal azides. On disposal, flush with a large volume of water to prevent azide build-up.

CARDS: Care should be taken not to finger-mark the test areas, since this may result in an oily deposit and improper test results.