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(mb GeneXpert) TEST EBOLA, cartridge GXEBOLA-CE-50

https://medicalguidelines.msf.org/en/node/288
https://unicat.msf.org/cat/product/56941
NST ELAEMBIT106

Valid Article

Former Code(s): ELAEZBE1066 ELAEPCRT601 DDGTZFR0256 ELAEZNL0671
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
W0105040528 - Ebola (filovirus) - na reagents
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.
UN1760
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).
CT25
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/588506/image_1920?unique=9d080c2

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(mb GeneXpert) TEST EBOLA, cartridge GXEBOLA-CE-50

CAUTION

This article is labelled as a unit to faciliate the order but is always packaged in kit of 50 cartridges

Definition

The Xpert Ebola Assay is a real-time reverse transcription polymerase chain reaction (RT-PCR) test used on the GeneXpert platform intended for the qualitative detection of RNA from the Ebola Zaire virus (detected in the West Africa outbreak in 2014) in EDTA venous whole blood from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors.

Specifications

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Material

  • GeneXpert Ebola assay cartridges containing :
    • Bead 1, Bead 2 and Bead 3 (freeze-dried)
    • 0.5 ml of rinse solution
    • 2.0 ml of elution reagent
    • 2.0 ml of binding solution
  • Ebola sample reagent with guanidinium thiocyanate lysis solution

Components

  • 50 GeneXpert Ebola assay cartridges with integrated reaction tubes
  • ​50 x 2.5 ml of Ebola sample reagent
  • 5 x 10 Disposable 1 ml Transfer Pipettes
  • 1 CD

Technical specifications

  • The Xpert Ebola kit (GXEBOLA-CE-50) contains sufficient reagent for 50 specimens
  • Beads are solid white components in cartridges
  • Reagents are clear liquids which are primarily buffered in aqueous solutions

Quality control

Each test includes a Sample Volume Adequation (SVA) control, Cepheid internal control (CIC) and a Probe Check Control (PCC).

External controls should be used in accordance with local, regional, national requirements of accreditation organisms, as applicable.

Packaging & Labelling

Kit for 50 tests

Transport Dangerous Goods

  • UN1760
  • Hazard class 8
  • Packing group III
  • Proper shipping name: corrosive liquid n.o.s (guanidine thiocyanate)

Instructions for use

Precautions for Use

  • Do not use reagent that are visibly turbid or with a colour change.
  • Do not use a cartridge that has leaked.

Storage

  • Store at 2°C-28°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

The cartridge contains guanidium thiocyanate as the lysis reagent. This chemical is highly toxic and all care should be taken when using the cartridges in case of spills etc.

Please note that as this chemical is also highly toxic to aquatic life, it should optimally be disposed of by incineration. No liquids from the cartridge should be released into the environmen

  • Skin corrosion/irritation, Category 1, H314
  • Serious eye damage/eye irritation, Category 1, H318
Image

Signal Word

Danger

H314Causes severe skin burns and eye damage.
P260Do not breathe dust/fume/gas/mist/vapours/spray.
P280Wear protective gloves/protective clothing/eye protection/face protection
P310Immediately call a POISON CENTER or doctor/physician.
P321Specific treatment (see ... on this label)
P303 + P361 + P353IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing.
P305 + P351 + P338IF IN EYES: rinse cautiously with water for several minutes. If the victim wears contact lenses, remove them if possible. Keep rinsing
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Validated by OCB Laboratory Referent - Pascale Chaillet - July 2025