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(mb GeneXpert) TEST HIV-1 Qual EID, cartridge GXHIV-QA-CE-10

https://medicalguidelines.msf.org/en/node/289
https://unicat.msf.org/cat/product/53350
STD ELAEMBIT104

Valid Article

Former Code(s): DDGTZFR0245 ELAEPCRT104 ELAEMBIT102 DDGTZBE0232 ELAEVLHT102
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.
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 Qual EID, 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 HIV-1 Qual assay, performed on the GeneXpert. It is cartridge based and is a qualitative in vitro diagnostic test designed to detect HIV-1 total nucleic acids using human whole blood and dried blood spots.

The Xpert HIV-1 Qual assay is intended to aid in the diagnosis of HIV-1 infection in conjunction with clinical presentation and other laboratory markers.

The assay is not intended to be used as a donor screening test for HIV-1.

Specifications

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Technical specifications

The Xpert® HIV-1 Qual (GXHIV-QA-CE-10) contains sufficient reagents for 10 specimens.

Each kit contains following:

  • 10 HIV Qual (GXHIV-QA-CE-10) assay cartridges with integrated reaction tubes
    • Bead 1, bead 2, bead 3 (freeze dried): 1 of each per cartridge
    • Lysis reagent (Guanidium Thiocyanate): 1.4ml per cartridge
    • Rinse reagent: 0.5ml per cartridge
    • Elution reagent: 2.5ml per cartridge
    • Binding reagent: 2.4ml per cartridge
    • Proteinase K reagent: 0.48ml per cartridge
  • 10 disposable 1 ml transfer pipettes
  • 1 CD containing the package insert

Quality control

Each test includes a Sample Volume Adequacy (SVA) control, 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

To be Ordered Separately

The Eppendorf ThermoMixer C and Smartblock need to be ordered for DBS application only (see related articles).

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

  • Do not open a cartridge until you are ready to perform testing
  • Do not use the cartridge if it appears wet or if the lid seal appears to have been broken.
  • Do not use a cartridge that has been dropped after removing it from the packaging.
  • Do not shake the cartridge. Shaking or dropping the cartridge after opening the cartridge lid may yield invalid results.
  • Do not use any reagents that have become cloudy or discolored.
  • 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.

Classification EC Regulation N° 1272/2008

  • Acute toxicity oral, Category 5, H302
  • Skin mild Irritation, Category 5, H313
  • Eye Mild irritation, Category 2B, H320

Signal Word

Warning

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