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TEST BRUCELLOSIS, Rose Bengal, ser, 1t (Spinreact 1200901)

https://medicalguidelines.msf.org/en/node/275
https://unicat.msf.org/cat/product/11418
NST SSDTBRUC50T

Valid Article

Former Code(s): DDGTBRUC1T- SSDTBRUC1T-
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.
21
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W0105011701 - Brucella
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.
UN3265
Hazardous materials and products (identified by their 4-digit transport UN-number) must be transported under certain conditions as specified in the MSDS sheet (Material Safety Data Sheet).
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)
https://unicat.msf.org/web/image/product.template/588507/image_1920?unique=16a2795

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BRUCELLOSIS TEST (Rose Bengal)

CAUTION

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

Definition

A​gglutinating test for the qualitative and semi-qualitative detection of antibodies (IgG and IgM) to Brucella in human serum.

Specifications

The sensitivity of this test is standardized at 25 IU/ml, against the 2nd International Preparation of anti-Brucella abortus from NIBSC (WHO).

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Components

  • 2,5 ml Rose Bengal suspension (white cap): mix of inactivated brucella cells + acid buffer + rose bengal (stain)
  • 1 ml Positive control‌ (red cap)
  • 1 ml Negative control‌ (blue cap)
  • 8 x 6 disposable slides

All solutions contain 2-Methyl-2H-isothiazol-3-one (Proclin 950)

Technical specifications

  • Agglutination test
  • Analytical sensitivity: 25 (±5) IU/mL
  • Sample type: serum
  • Sample volume: 50µl
  • Reaction time: 4 minutes
  • No prozone effect was detected up to 1000 IU/mL
  • Rose bengal solution: bright rose liquid
  • Positive control: yellowish liquid
  • Negative control: colorless or yellowish liquid

Packaging & Labelling

Set containing the reagents and equipment needed to perform 50 tests

Transport Dangerous Goods

Rose Bengal solution:

  • UN3265
  • Class: 8
  • Packing group: III
  • Proper shipping name: Corrosive liquid, acidic, organic, n.o.s

To be Ordered Separately

  • Centrifuge
  • Vortex
  • Precision pipette; 50 µl

Instructions for use

Follow the instructions in the leaflet.

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Precautions for Use

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

Caution: reagent and controls contain phenol.

Storage

  • Keep refrigerated between 2 and 8ºC, protected from light
  • Do not freeze
  • Shelf life 21 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life

(Cf Introduction: Thermosensitive products)

Waste management

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).

Incinerate used cards and equipment.

Classification EC Regulation N° 1272/2008

Rose bengal solution

  • Skin corrosion/irritation, category 1, Sub-category 1C, H314
  • Serious eye damage/eye irritation, category 1, H318
  • Skin sensitisation, category 1, H317

Positive and negative control

  • Skin sensitisation, category 1, H317

Signal Word

Rose bengal solution: Danger

Image Image
H314Causes severe skin burns and eye damage.
H317May cause an allergic skin reaction
P260Do not breathe dust/fume/gas/mist/vapours/spray.
P264Wash … thoroughly after handling
P501Dispose of contents/container to location in accordance with local and regional/ national/ international regulations

Signal Word

Positive control: Warning

Image
H317May cause an allergic skin reaction
P261Avoid breathing dust/fume/gas/mist/vapours/spray.
P272Contaminated work clothing should not be allowed out of the workplace.
P501Dispose of contents/container to location in accordance with local and regional/ national/ international regulations

Signal Word

Negative control: Warning

Image
H317May cause an allergic skin reaction
P261Avoid breathing dust/fume/gas/mist/vapours/spray.
P272Contaminated work clothing should not be allowed out of the workplace.
P501Dispose of contents/container to location in accordance with local and regional/ national/ international regulations
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Validated by OCB Laboratory referent - Pascale Chaillet - July 2025