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MENINGITIS A, B, C, Y/W135 TEST (Pastorex), CSF,1 test 61607

https://medicalguidelines.msf.org/en/node/272
https://unicat.msf.org/cat/product/19102
STD SSDTMENT25T

Valid Article

Former Code(s): DDGTMENT2WT
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
W0104080304 - Meningitis 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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MENINGITIS A,B,C,Y/W135 TEST (Pastorex)

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 25.

Definition

Rapid test for the detection of bacteria responsible for meningitis in CSF (cerebral spinal fluid).

Detects the meningococcus A, B, C, Y/W135, the Streptococcus B and Streptococcus pneumoniae, as well as the Haemophilus influenzae B.

In addition to its use on CSF during epidemics, the Pastorex meningitis is used in bacteriology laboratory with bacterial colonies (associated material will be adapted, depending of the procedures of test).

It is not only used to analyse the CSF but it is used on all types of colonies growing from any kind of sample and suspected to be S. pneumoniae, H. influenzae or N. meningitidis.

Specifications

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Components

  • 10 reagents:
    • 1: dropper bottle containing 1.2 ml of white latex sensitized by a monoclonal antibody of mouse, specific of Neisseria meningitidis group B/E Coli K
    • 2: dropper bottle containing 1.2 ml of purple latex, negative control of reagent R1
    • 3: dropper bottle containing 0.40 ml of white latex sensitized by antibodies of rabbit, specific of Haemophilus influenzae type b
    • 4: dropper bottle containing 0.40 ml of green latex sensitized by antibodies of rabbit, specific of Streptococcus pneumoniae
    • 5: dropper bottle containing 0.40 ml of yellow latex sensitized by antibodies of rabbit, specific of Streptococcus group B
    • 6: dropper bottle containing 0.40 ml of blue latex sensitized by antibodies of rabbit, specific of Neisseria meningitidis group A
    • 7: dropper bottle containing 0.40 ml of red latex sensitized by antibodies of a rabbit, specific of Neisseria meningitidis group C
    • 8: 1 dropper bottle containing 0.40 ml of pink latex sensitized by antibodies of a rabbit, specific of Neisseria meningitidis group Y/W135
    • 9: 1 dropper bottle containing 0.40 ml of prune latex negative control of R3, R4, R5, R6, R7, R8. This latex is sensitized by IgG of non immunized rabbit
    • 10: positive control: polyvalent antigenic extract to be reconstituted with 1 ml distilled water. Contains the polysaccharide antigens of Neisseria meningitidis A, B, C, Y/W135, Haemophilus influenzae type b, Streptococcus B and Streptococcus pneumoniae
  • Disposable cards to perform agglutination reactions with reagents 3, 4, 5, 6, 7, 8 and 9
  • Disposable plastic agitators

Technical specifications

For meningococcus A:

  • Sensitivity: 88%
  • Specificity: 93%

Packaging & Labelling

Kit of 25 tests

To be Ordered Separately

Lumbar puncture needles and sampling equipment

Please consult the “Updated laboratory procedures, 2022” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources.

https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Laboratory-Manual-page.aspx

For offline access, contact your laboratory advisor.

Instructions for use

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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

  • Keep refrigerated between 2ºC and 8ºC
  • Do not freeze
  • Shelf life: 12 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life
  • Whenever using the kit, always check the kit validity by using the positive and the negative control.

(Cf Introduction: Thermosensitive products)

Waste management

Presence of mercury in the reagents as thimerosal 0.02%. Please contact your watsan referent for advice regarding proper disposal.

Contains 5-Chloro-2-methyl-3(2H)-isothiazolone, mixture with 2-methyl-3(2H)-isothiazolone

Signal Word

Warning

Image
H317May cause an allergic skin reaction
H412Harmful to aquatic life with long lasting effects
P261Avoid breathing dust/fume/gas/mist/vapours/spray.
P280Wear protective gloves/protective clothing/eye protection/face protection
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

Enables to determine the bacteria responsible for meningitis before launching an immunization campaign.

Detects the W135.

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