TEST, STAPHYLOCOCCUS AUREUS (Pastorex), 1 test

STD SBIDILATSTAPH

Valid Article

Former Code(s): SLASZBE0496 SBIDLATXCOAG SBIDILATCOAG SSDTSTAP50T DDGTZFR0208
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
15
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W0104080303 - Staphylococci slide tests
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
The order of this product needs to be justified and is only acceptable under certain conditions.
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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S. AUREUS LATEX AGGLUTINATION (Pastorex)

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 50 tests.

Definition

Staphylococcus aureus agglutination latex test is a rapid slide agglutination test for the simultaneous detection of the fibrinogen affinity (clumping factor), protein A, and capsular polysaccharides of Staphylococcus aureus.

This kit is only to be used on cultured bacteria, not directly on clinical specimen.

Specifications

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Components

  • Latex test: 1 dropper bottle of 1 ml of red latex sensitised by bovine albumin solution, fibrinogen, IgG, and monoclonal antibodies directed against capsular polysaccharides of Staphylococcus aureus.
  • Negative control: 1 dropper bottle of 1 ml of negative control reagent of red latex sensitised by bovine albumin solution.
  • 16 disposable agglutination cards
  • 2 x 100 rods

Technical specifications

  • Specimen: cultured bacteria (not directly on clinical specimen!)
  • Negative control and latex test: liquid suspension, red

Packaging & Labelling

1 kit of 50 tests

Instructions for use

  • Follow the instructions of the package insert.
  • All the reagents and the sample should be used at a temperature between 18°C and 30°C.
  • Do not touch the reaction surface of the agglutination cards.
  • Shake the bottles of latex before use.
  • Wipe the tip of the reagent dropper bottle in order to obtain well-calibrated drops.
  • Hold the reagent bottle vertical to deposit drops.

Please consult the “Bacteriology laboratory procedures and resources” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources: https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Bacteriology-Laboratory-Resources.aspx

For offline access, contact your laboratory advisor

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Precautions for Use

All biological samples must be considered as potentially infectious and handled with the usual precautions (compulsory wearing of gloves, hand washing, etc.).

Storage

  • Store at 2°C to 8°C after opening.
  • Do not use after the expiry date.
  • Shelf life: 15 months.
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life.
  • Do not freeze the latex reagents.
  • Store the latex reagent vertically.

(Cf Introduction: Thermosensitive products)

Waste management

After use, sterilise the cultures and all contaminated material.

Presence of substance with hazardous characteristics. Please contact your watsan referent for advice on proper disposal.

Detailed hazard and precautionary information can be found in the safety data sheet (SDS).

Classification EC Regulation N° 1272/2008

Negative control and latex test

  • Skin Sens: Category 1A, H317
  • Chronic aquatic toxicity, Category 3, H412
Image

Signal Word

Warning

H317May cause an allergic skin reaction
H412Harmful to aquatic life with long lasting effects
P273Avoid release to the environment
P280Wear protective gloves/protective clothing/eye protection/face protection
P302 + P352IF ON SKIN: wash with plenty of soap and water
P333 + P313If skin irritation or rash occurs: Get medical advice/attention.
P501Dispose of contents/container to location in accordance with local and regional/ national/ international regulations

Signal Word

Warning

Image
H317May cause an allergic skin reaction
H412Harmful to aquatic life with long lasting effects
P273Avoid release to the environment
P280Wear protective gloves/protective clothing/eye protection/face protection
P302IF ON SKIN:
P333 + P313If skin irritation or rash occurs: Get medical advice/attention.
P501Dispose of contents/container to location in accordance with local and regional/ national/ international regulations

MSF requirements

Reserved to bacteriology programmes.

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