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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.
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 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.

HIV-1 Group M: A-D, F-H, J,K, CRFA/B, CRF-A/E, CRF-A/G, CRF-BC, CRF06 Group O, Group N and Group P

Specifications

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Technical specifications

  • Each kit is composed of:
    • HIV-1 VL XC Cartridges with Integrated Reaction Tubes (10). Each cartridge contains:
      • 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
    • Disposable 1 mL Transfer Pipettes 10 per kit
    • CD 1 per kit
    • Assay Definition File (ADF)
    • Instructions to import ADF into GeneXpert software
    • Instructions for Use (Package Insert)
  • Beads are solid white component in cartridge; reagents are clear liquids which are primarily buffered in aqueous solutions

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

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.

Classification EC Regulation N° 1272/2008

Acute toxicity Oral, 5

Signal Word

Warning

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