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TEST, STREPTOCOCCUS A, B, C, D, F, G (Pastorex), 1 test

https://unicat.msf.org/cat/product/40698
STD SBIDILATSTREP

Valid Article

Former Code(s): DDGTZBD0104 SSDTSTRE60T
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.
12
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W0104080302 - Streptococci grouping 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.
P
The order of this product needs to be justified and is only acceptable under certain conditions.
0208
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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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Streptococcus A, B, C, D, F, G 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 60.

Definition

PASTOREX STREP is a rapid agglutination test for grouping streptococci according to Lancefield classification. The test involves use of latex suspensions specific for groups A, B, C, D, F, and G.

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

Specifications

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Components

Each kit contains:

  • Six vials of 1 ml of latex suspension, specific for group A, B, C, D, F, and G streptococci, respectively. The latex particles are coated with group-specific rabbit immunoglobulins.
  • Two vials of freeze-dried extraction enzyme. The content of the vial should be reconstituted with 10 ml distilled water.
  • One vial of 1.5 ml polyvalent positive control antigen, made of an extracts mixture of Lancefield of group A, B, C, D, F, and G streptococci.
  • 3 x 125 disposable rods
  • 4 x 15 disposable agglutination cards (8 circles).

Technical specifications

  • Specimen: cultured bacteria (not directly on clinical specimen!)

Packaging & Labelling

Kit for 60 tests:

  • 6 x 1 ml vials
  • 1 x 1.5 ml vial
  • 2 bottles of liophilised extraction enzyme
  • 60 agglutination cards
  • 375 mixing sticks

To be Ordered Separately

  • Micropipettes for 40 µl and 300 µl
  • Pipettes for 10 ml
  • Loop for the collection of bacterial colonies
  • Sterile distilled water
  • Sterile physiological water
  • Hemolysis tubes or micro-tubes (1 per strain to be tested)
  • Timer
  • Disinfectant bath
  • Dry incubator

Instructions for use

  • Let the reagents get to room temperature before starting the test.
  • Shake the bottles of latex before use.
  • Hold the bottle with latex in vertical position when placing the drop.
  • Use a new rod for each reaction.
  • Do not touch the reaction surface of the agglutination card.
  • Ensure that the caps of the dropper bottles are firmly tightened to avoid contamination or drying of the reagents.
  • Use distilled water for reconstitution of enzyme extraction

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.).

Avoid any contact with the eyes, skin and mucous membranes (presence of sodium azide).

Storage

  • Store between 2°C and 8°C
  • Do not freeze
  • Not to be used beyond expiry date
  • After reconstitution, the extraction enzyme is stable up to 4 months at 2 to 8°C
  • Shelf life: 12 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life

(Cf Introduction: Thermosensitive products)

Waste management

After use, sterilise the cultures and all contaminated material.

Presence of substances 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

Extraction enzyme:

  • Causes skin irritation, Category 2 H315
  • Causes serious eye Irrit. Category 2 H319
  • May cause respiratory irritation. Category 3 H335

Polyvalent positive control antigen + Strep A-G latex:

  • Skin Sens. Category 1 H317
  • Aquatic Chronic Category 3 H412
Image

Signal Word

Warning

(Extraction enzyme)

H315Causes skin irritation
H319Causes serious eye irritation
H335May cause respiratory irritation
P405Store locked up.
P261Avoid breathing dust/fume/gas/mist/vapours/spray.
P321Specific treatment (see ... on this label)
P302 + P352IF ON SKIN: wash with plenty of soap and water
P305 + P351 + P338IF IN EYES: rinse cautiously with water for several minutes. If the victim wears contact lenses, remove them if possible. Keep rinsing
P501Dispose of contents/container to location in accordance with local and regional/ national/ international regulations
P362 + P364Take off contaminated clothing and wash it before reuse.

Signal Word

Warning

(polyvalent positive control antigen + Latex Strep A-C-F-G)

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
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

(Latex Strep B-D)

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
P321Specific treatment (see ... on this label)
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

MSF requirements

Reserved to bacteriology programmes

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