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(mb GeneXpert) TEST HIV-1 VL, cartridge, GXHIV-VL-CE-10

https://medicalguidelines.msf.org/en/node/289
https://unicat.msf.org/cat/product/53351
STD ELAEMBIT105

Valid Article

Former Code(s): DDGTZBE0231 DDGTZFR0246 ELAEPCRT105
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).
Article is intended to be used with children (<12 years) ONLY.
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.
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)

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(mb GeneXpert) TEST HIV-1 VL, cartridge

This cartridge will be phased out by December 2024 by the manufacturer and will be replaced by a new cartridge: GXHIV-VL-XC-CE-10

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® HIV-1 Viral Load assay runs on the GeneXpert System. It is a cartridge based test and allows measurement of HIV-1 RNA concentration (or viral load) in plasma. Assessment of the viral load levels is a strong predictor of the HIV disease progression.

The Xpert® HIV-1 Viral Load assay includes RNA extraction, purification, reverse transcription and cDNA quantitation (by real-time PCR) and provides results in 90 minutes.

Specifications

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Technical specifications

The Xpert® HIV-1 Viral Load (GXHIV-VL-CE-10) contains sufficient reagents for 10 specimens.

Each kit contains the following:

  • 10 HIV VL assay cartridges (GXHIV-VL-CE-10) with integrated reaction tubes per cartridge:
    • Bead 1, bead 2, bead 3 (freeze dried): 1 of each
    • Lysis reagent (Guanidium Thiocyanate): 2.0ml
    • Rinse reagent: 0.5ml
    • Elution reagent: 1.5ml
    • Binding reagent: 2.4ml
    • Proteinase K reagent: 0.48ml

Beads are solid white components in cartridges; reagents are clear liquids which are primarily buffered in aqueous solutions.

  • 10 disposable 1 ml transfer pipettes
  • 1 CD containing the package insert

Quality control

Each test includes a Sample Volume Adequacy (SVA) control, Internal Quantitative Standard High and Low (IQS-H and IQS-L) which is also a Sample Processing Control (SPC) 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

Instructions for use

Follow the instructions for use

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.

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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.

Lysis reagent contains guanidium thiocyanate

Acute toxicity oral, 5

H302Harmful if swallowed
H320Causes eye irritation
H313May be harmful in contact with skin
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