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The BBL™ Staphyloslide™ Latex Test is a latex slide agglutination test for the differentiation of staphylococci which possess clumping factor and/or Protein A, usually present with Staphylococcus aureus, from staphylococci that do not possess these properties.¹

It has been reported that approximately 97% of human strains of S. aureus possess both bound coagulase and extracellular staphylocoagulase. Protein A is found on the cell surface of about 95% of human strains of S. aureus and has the ability to bind the Fc portion of immunoglobulin G (lgG).²

Perform Daily Quality Control each day the kit is used. Follow the methods given in "Test Procedure".

1. Positive Control: Use a known S. aureus strain such as ATCC™ 25923. Ensure that agglutination occurs within 20 sec.

2. Negative Control: Use a known S. epidermidis strain such as ATCC 12228. Ensure that the reagent remains smooth and unagglutinated for the entire 20 sec of the test.

NOTE: Do not use the reagents if reactions with the control organisms are incorrect.

Quality control requirements must be performed in accordance with applicable local, state and/or federal regulations or accreditation 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 practices.

For in vitro Diagnostic Use.

REAGENTS: The test latex can become contaminated if the dropper tip is allowed to touch the specimen on the reaction card. Ensure caps on reagent bottles are securely fitted after each use to prevent contamination and drying out of the reagents.

WARNING: The reagents contain material of human origin. The human plasma proteins used in the manufacture of the reagent have been tested for the presence of the antibody to HIV (Human Immunodeficiency Virus), Hepatitis C and HBsAg (Hepatitis B surface Antigen) and found to be nonreactive. Because no test method can offer complete assurance that infectious agents are absent, SPECIMENS AND THESE REAGENTS SHOULD BE HANDLED AS THOUGH CAPABLE OF TRANSMITTING AN INFECTIOUS DISEASE. The U.S. Food and Drug Administration (FDA) recommends such material be handled at a Biosafety Level 2. BSL 2 is referenced in the U.S. Centers for Disease Control and Prevention/National Institutes of Health (CDC/NIH) manual, Biosafety in Microbiological and Biomedical Laboratories.

Reagents contain sodium azide, which is 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: Cards must be flat for proper reactions. If necessary, flatten cards by bowing back in a direction opposite to that of the curl. Care should be taken not to finger-mark the test areas, since this may result in an oily deposit and improper test result. Use each card once and discard. Store cards in the original package in a dry area at room temperature.