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(mb GeneXpert) TEST HCV VL Fingerstick, cart. GXHCV-FS-CE-10

https://medicalguidelines.msf.org/en/node/286
https://unicat.msf.org/cat/product/94955
NST ELAEMBIT126

Valid Article

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
W0105020307 - Hepatitis C virus - molecular biology
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).
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/589076/image_1920?unique=da309b5

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(mb GeneXpert) TEST HCV VL Fingerstick, cartridge

CAUTION

This test (= 1 cartridge) is worded and codified by unit to make the order easier, but it is always packaged in kit of 10.

Definition

The Xpert HCV VL Fingerstick assay, performed on the GeneXpert.

It is a cartridge based detection and quantification of Hepatitis C virus RNA by RT-PCR finger stick blood or venous whole blood.

Specifications

  • WHO prequalified December 2022 (PQDx 0453-070-00)
  • Sample type: capillary whole blood or venous whole blood with EDTA
  • Sample volume: 100 µl
  • Beads are solid white components in cartridges reagents are clear liquids which are primarily buffered in aqueous solutions
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Material

Xpert® HCV VL Fingerstick cartridges with integrated reaction tubes contains:

  • Bead 1, Bead 2, and Bead 3 (freeze-dried) 1 of each
  • Lysis Reagent (Guanidinium Thiocyanate) 1.0 mL
  • Rinse Reagent 0.5 mL
  • Elution Reagent 1.5 mL
  • Binding Reagent 1.5 mL

Contains Guanidine thiocyanate

Components

  • 10 Xpert® HCV VL Fingerstick cartridges with integrated reaction tubes
  • 1 CD with Assay Definition Files (ADF) and instructions for use

Technical specifications

The Xpert HCV VL Fingerstick GXHCV-FS-CE-10 contains sufficient reagents for 10 specimens.

Packaging & Labelling

1 kit = 10 tests

Transport Dangerous Goods

  • UN3265
  • Hazard class 8
  • Packing group III
  • Proper shipping name: Corrosive liquid, acidic organic, n.o.s (Guanidine thiocyanate)

To be Ordered Separately

  • Bleach 70%
  • Ethanol
  • Disposable gloves
  • Disposable Minivette 100 µl K3E for capillary blood use
  • Safety lancet

Instructions for use

Follow the instructions for use

Precautions for Use

  • Do not open a cartridge until you are ready to perform testing
  • Do not use a cartridge that has leaked

Storage

  • Store between 2°C-28°C
  • Shelflife 12 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life

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 environment.

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

  • 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 bu OCP laboratory referent - Newton Ambaisi (October 2025)