ELITex Staph

Intended use

Staphylococci are a serious problem for hospital epidemiology. Among them, Staphylococcus aureus is the main pathogenic species and is responsible for septicemia and nosocomial infections.
Multi-drug resistance poses considerable therapeutic problems, particularly with respect to methicillin resistant staphylococci. The ability to rapidly differentiate Staphylococcus aureus from other staphylococci species is therefore a necessity in microbiological diagnosis.

The ELITex Staph is a slide agglutination test for the rapid identification of Staphylococcus aureus (MRSA included) from primary culture plates. It is rapid, easy-to-use and easy-to-read with results available within 1 minute.

Principle

Red latex particles are sensitized with three proteins:

• Fibrinogen that reacts with “Clumping Factor”
• The Fc fragment of human IgG that reacts with Staphylococcus aureus protein A
• Anti-Staphylococcus aureus capsular polysaccharides polyclonal IgG.

The presence of Staphylococcus aureus is revealed by a strong agglutination reaction. In the absence of Staphylococcus aureus, no agglutination appears.

The test procedure is easy with results available in less than a minute.

The kit is complete and includes:

• TEST LATEX
• CONTROL LATEX (internal control)
• Test cards
• Single use sticks

Simple protocol

Easy-to-read and easy-to-interpret results

Reagents and material

• TEST LATEX:
  • Dispenser vial of 1.8 mL of sensitized latex
  • Ref. 22711 Quantity: 1
  • Dispenser vial of 2.4 mL of sensitized latex
  • ref. 22712 Quantity: 2
• CONTROL LATEX:
  • Dispenser vial of 1.8 mL of unsensitized latex
  • Ref. 22711 Quantity: 1
  • Dispenser vial of 2.4 mL of unsensitized latex
  • Ref. 22712 Quantity: 2
• TEST CARD:
  • Disposable reaction card
  • Ref. 22711 Quantity: 15
  • Ref. 22712 Quantity: 40
• STICK:
  • Disposable mixing sticks
  • Ref. 22711 Quantity: 120
  • Ref. 22712 Quantity: 320

Stability and storage

• The reagents are ready-to-use.
• All the reagents are stored at 2-8°C. Do not freeze.
• The results of the stability study indicate that the product has a tability of 18 months at 2-8°C from its manufacture.

Performance

• ELITex Staph assay has a good sensitivity for methicillin resistant strains of Staphylococcus aureus (MRSA), producing little protein A and/or fibrinogen affinity factor. The sensitivity of the assay is 99.02% and its specificity is 99.07%.

Material required but not supplied

• Incubator calibrated at 37°C
• Contaminated waste container