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(mb GeneXpert) TEST HIV-1 VL XC, cart., GXHIV-VL-XC-CE-10

https://medicalguidelines.msf.org/en/node/289
https://unicat.msf.org/cat/product/94486
STD ELAEMBIT124

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.
18
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W0105030107 - Hiv 1 - 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.
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/586886/image_1920?unique=f032c4d

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(mb GeneXpert) TEST HIV-1 VL XC, cart., GXHIV-VL-XC-CE-10

This cartridge is the replacement of ELAEMBIT105, it is the new version with improved performance.

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 HIV-1 VL XC test uses real-time reverse transcription polymerase chain reaction (RT-PCR) technology to achieve high sensitivity for the quantitative detection of HIV-1 RNA in human plasma from HIV-1 infected individuals.

Specifications

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Material

  • Each cartridge is composed of:
    • Bead 1, Bead 2, and Bead 3 (freeze-dried) 1 of each
    • Lysis Reagent (Guanidinium Thiocyanate) 2.0 mL
    • Rinse Reagent 0.5 mL
    • Elution Reagent 1.5 mL
    • Binding Reagent 2.4 mL
    • Proteinase K Reagent 0.48 mL
  • Contains guanidine thiocyanate

Components

Each kit is composed of:

  • 10 HIV-1 VL XC Cartridges with Integrated Reaction Tubes
  • 10 Disposable 1 mL Transfer Pipettes
  • 1 CD

Technical specifications

  • Beads are solid white component in cartridge; reagents are clear liquids which are primarily buffered in aqueous solutions
  • Sample: plasma from whole blood collected on PPT or K2-EDTA tubes
  • Volume of sample: 1 ml
  • Quality control
    • Each test includes a Sample Volume Adequacy (SVA) control, Internal Quantitative Standard High and Low (IQS-H and IQS-L), Lot Specific Parameters (LSP), and a Probe Check Control (PCC).
    • External controls, not available in the kit, should be used in accordance with Ministry Of Health requirements as applicable.

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

  • GeneXpert Dx system
  • Bleach or sodium hypochlorite
  • Ethanol or denaturated ethanol

Instructions for use

Follow the instructions for use

Precautions for Use

  • Manipulation and transport practices : do not spill to avoid leaking
  • Do not open a cartridge until you are ready to perform testing
  • Use the cartridge within 4 hours after opening the cartridge lid
  • Do not use a cartridge that has leaked

Storage

  • Store between 2 and 28°C
  • Shelf life: 18 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of 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 damae/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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