ITEST S. AUREUS LATEX - User Manual

Specification and Usage

The ITEST S. AUREUS LATEX set is designed for fast, easy and accurate identification of Staphylococcus aureus. The primary material used for determination are colonies from blood agar.

Test Principle

Pathogenic strains of S. aureus produce bound coagulase enzyme, a so called clumping factor, and cells of these strains contain protein A. The rabbit immunoglobulin (IgG) and fibrinogen are bound to the latex particles of ITEST S. AUREUS LATEX. When the clumping factor reacts with fibrinogen or protein A reacts with IgG, a clear agglutination of the latex suspension occurs. Clumping factor and protein A are mutually independent factors and their detection is important in identifying S. aureus.

Performing the Test

1. Put one drop of ANTI S. AUREUS latex suspension on the black field of the detection card.
2. Collect about 5 colonies of the test strain and mix them well into the latex suspension using the included stirrer.
3. Rock the detection card for one minute. When testing multiple stems at once, be sure to not mix materials from adjacent surfaces. If this happens repeat the test.

Rating

In a positive case, when the clumping factor reacts with fibrinogen or protein A reacts with rabbit IgG, an obvious agglutination of ANTI S. AUREUS will appear in the latex suspension within one minute.

Agglutination = creation of grains or clumps visible to the naked eye, with essentially clear fluid between them.

In the negative case an agglutination does not appear in the latex suspension within one minute.

NOTE: Ignore thin traces of granular material, which can be visible even in negative cases.

Warning

1. The ITEST S. AUREUS LATEX kit is sold in packages of 50 tests and are for in vitro use only.
2. Store the kit in a dark place at 2–8 °C and use before the expiration date printed on the package. Latex suspension must never be frozen.
3. If the primary packaging is damaged, do not use the IVD and instead contact the manufacturer (supplier).
4. Dispose of any unused IVDs and empty packaging material in accordance with the Waste Act No. 185/2001 Coll. in categories: 15 01 01 - paper packaging; 15 01 02 - plastic packaging; 15 01 07 - glass containers, aluminium - 17 04 02, chemicals containing dangerous substances - 18 01 06, residues and unused IVD dispose in category 18 01 09 - other unusable drugs. Waste which requires special treatment for infection prevention dispose in category 18 01 03.