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(mb GeneXpert)TEST HIV-1 Qual XC EID,cart. GXHIV-QA-XC-CE-10

https://medicalguidelines.msf.org/en/node/289
https://unicat.msf.org/cat/product/94688
STD ELAEMBIT125

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).
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)
https://unicat.msf.org/web/image/product.template/586626/image_1920?unique=f032c4d

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(mb GeneXpert)TEST HIV-1 Qual XC EID, cartridge

This article replaces and is the new version of ELAEMBIT104, with extented coverage.

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

Xpert HIV-1 Qual XC (Extended Coverage) is an in vitro nucleic acid amplification test for the qualitative detection of human immunodeficiency virus type 1 (HIV-1) total nucleic acids, on the automated GeneXpert System. The test is used to detect HIV-1 in human dried blood spots (DBS) and EDTA capillary or venous whole blood (WB) specimens from individuals suspected of HIV-1 infection.

Xpert HIV-1 Qual XC is intended to aid in the diagnosis of HIV-1 infection in conjunction with clinical presentation and other laboratory markers in infant, adolescent and adult populations.

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

Specifications

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Technical specifications

The Xpert® HIV-1 Qual XC (GXHIV-QA-XC-CE-10) contains sufficient reagents for 10 specimens. Each kit contains following:

  • 10 HIV Qual (GXHIV-QA-XE-CE-10) assay cartridges with integrated reaction tubes
    • Bead 1, Bead 2, and Bead 3 (freeze-dried) 1 of each per cartridge
    • Lysis Reagent (Guanidinium Hydrochloride) 1.2 mL per cartridge
    • Rinse Reagent 0.5 mL per cartridge
    • Elution Reagent 1.5 mL per cartridge
    • Wash Reagent (Guanidinium Hydrochloride) 3.2 mL per cartridge
    • Proteinase K Reagent 0.48 mL per cartridge
  • Disposable 100 μL Transfer Pipettes 1 bag of 10 per kit
  • CD
  • Assay Definition File (ADF)
  • Instructions to import ADF into software
  • Instructions for Use (Package Insert)

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

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

Transport Dangerous Goods

Transport not regulated

To be Ordered Separately

  • GeneXpert DX System
  • Bleach or hypochlorite sodium
  • Ethanol or denaturated ethanol

If use of DBS:

  • The Eppendorf ThermoMixer C and Smartblock need to be ordered for DBS application only (see related articles).
  • DBS filter paper cards
  • Blood sample collection items
  • Sterile tweezers or forceps
  • Sterile scissors

Instructions for use

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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

  • Skin corrosion/irritation, category 2, H315
  • Serious eye damae/eye irritation, category 2, H319
Image

Signal Word

Warning

H315Causes skin irritation
H319Causes serious eye irritation
P264Wash … thoroughly after handling
P280Wear protective gloves/protective clothing/eye protection/face protection
P321Specific treatment (see ... on this label)
P332 + P313If skin irritation occurs: get medical advice/attention
P337 + P313If eye irritation persists: get medical advice/attention
P362 + P364Take off contaminated clothing and wash it before reuse.
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