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(mb GeneXpert) TEST HCV viral load, cartridge GXHCV-VL-CE-10

https://medicalguidelines.msf.org/en/node/286
https://unicat.msf.org/cat/product/65490
STD ELAEMBIT107

Valid Article

Former Code(s): DDGTZFR0253 ELAEZNL0672 ELAEPCRT107
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.
12
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W0105020307 - Hepatitis C virus - molecular biology
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.
P
The order of this product needs to be justified and is only acceptable under certain conditions.
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 HCV viral load, 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 HCV viral load assay is performed on the GeneXpert. It is cartridge based and is a quantitative in vitro diagnostic test designed to detect HCV nucleic acids using human serum or plasma (EDTA). The test utilizes automated reverse transcriptase polymerase chain reaction (RT-PCR) using fluorescence to detect the RNA of interest for the quantitation of HCV.

The Xpert HCV viral load quantifies HCV genotypes 1-6 over the range of 10 to 100,000,000 IU/ml. The assay is intended for use as an aid in the management of HCV infected patients undergoing antiretroviral therapy. The test measures HCV RNA levels at baseline and during treatment and can be used to predict sustained and non-sustained virological responses to antiretroviral therapy.

Results from Xpert HCV viral load may also be used to confirm HCV infection in the anti-HCV positive individuals. In anti-HCV positive individuals who test negative for HCV RNA, use of another anti-HCV serological assay may be considered for distinction between true HCV exposure and biologic false positivity. Repeat HCV RNA testing may be indicated in cases that have had HCV exposure in the last 6 months or have clinical evidence of HCV disease.

This assay is not intended to be used as a blood donor screening test for HCV.

Specifications

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Technical specifications

The Xpert® HCV Viral Load (GXHCV-VL-CE-10) contains sufficient reagents for 10 specimens.

Each kit contains following:

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

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

Key characteristics:

  • Sample: EDTA plasma or serum
  • Time to result: 1h45min
  • Internal QC: Sample processing control (SPC): armored RNA in the form of a dry bead that is included in each cartridge to identify adequate processing of the sample virus.

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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Storage

  • Store at 2 - 28°C
  • Shelf life: 12 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​

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

MSF requirements

Reserved for programmes with the management of patients with HCV.

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