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Febrile Antigens are used in agglutination tests as an aid in the diagnosis of certain febrile diseases such as tularemia. The patient's serum is tested directly for homologous antibodies by either a slide or tube agglutination test. These tests are qualitative and semi-quantitative. The rapid slide test is used primarily as a screening procedure especially useful when large numbers of sera must be examined. The tube test should be used to confirm positive results obtained by the slide test.

Francisella Tularensis Control Antiserum is used in agglutination tests in conjunction with the Febrile Antigen as a positive control.

Serological diagnosis of patients suspected of having infectious diseases characterized by persistent fever is dependent upon demonstration of an agglutination reaction between the appropriate antigen and the patient's serum.

The natural response to the invasion by pathogenic organisms is the production of antibodies. This immune response is highly individualized and in addition to the host's physiological status and genetic capabilities, a number of other factors are involved with the production of antibodies to a particular stimulus. These include the antigenicity of the organism, the total amount introduced to the host and the route of introduction, and whether the host has had previous exposure to the organism. These factors will determine the rate of antibody formation, the amount of antibodies produced and their persistence in the circulatory system.

At time of use, apply both positive and negative controls to check performance of the antigen, techniques and methodology.

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.

Francisella Tularensis Antigen is a suspension of nonviable bacterial cells containing 0.5% formaldehyde.

Francisella Tularensis Control Antiserum is a polyclonal rabbit antiserum containing 30% - 50% glycerin as a preservative.

For in vitro Diagnostic Use.

The Packaging of This Product Contains Dry Natural Rubber.

Warning: May cause sensitization by skin contact. Avoid contact with skin. Wear suitable gloves. If swallowed, seek medical advice immediately and show this container or label.

Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. "Standard Precautions"^3-6 and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids. Prior to discarding, sterilize specimen containers and other contaminated materials by autoclaving.