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.

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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

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Simple protocol

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

TEST LATEX	CONTROL LATEX	Interpretation
–	–	Negative reaction The strain tested is not Staphylococcus aureus
–	+
+	–	Positive reaction The strain tested is Staphylococcus aureus
+	+	Uninterpreted reaction

Reagents and material

Reference	Quantity	Description
22711	1	TEST LATEX: Dispenser vial of 1.8 mL of sensitized latex
	1	CONTROL LATEX: Dispenser vial of 1.8 mL of unsensitized latex
	15	TEST CARD: Disposable reaction card
	120	STICK: Disposable mixing sticks

Reference	Quantity	Description
22712	2	TEST LATEX: Dispenser vial of 2.4 mL of sensitized latex
	2	CONTROL LATEX: Dispenser vial of 2.4 mL of unsensitized latex
	40	TEST CARD: Disposable reaction card
	320	STICK: Disposable mixing sticks

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

 

Manufacturer: ELITech Microbio.
Product(s) intended for healthcare professionals.
Read the instructions on the label and/or instructions for use of the product(s).