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(mb GeneXpert) TEST MTB/XDR, cartridge GXMTB/XDR-10

https://unicat.msf.org/cat/product/85129
STD ELAEMBIT114

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.
17
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
PME
The order of this product needs to be justified and is only acceptable under certain conditions.
UN2920
Hazardous materials and products (identified by their 4-digit transport UN-number) must be transported under certain conditions as specified in the MSDS sheet (Material Safety Data Sheet).
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 MTB/XDR, 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 MTB/XDR assay only runs on the GeneXpert System with 10 color modules.

It is a cartridge-based, semiquantitative diagnostic test that can detect Mycobacterium tuberculosis (MTB) complex and resistance to isoniazid (INH), ethionamide (ETH), fluoroquinolone (FLQ), second line injectable drug.

The Xpert MTB/XDR assay purifies, concentrates, amplifies (by real-time PCR) and identifies targeted nucleic acid sequences in the genome of M. tuberculosis complex bacteria.

Specifications

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Components

  • 10 Xpert MTB/XDR assay cartridges with integrated reaction tubes:
    • Bead 1, 2, 3, 4 and 5 (freeze-dried) : 1 of each per cartridge
    • sample processing control bead (freeze-dried): 1 of each per cartridge
    • Reagent 1: 4 ml per cartridge
    • Reagent 2: 4 ml per cartridge

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

  • 10 Sample reagent bottles: 8 ml per bottle
  • 12 disposable transfer pipettes
  • 1 CD (assay definition, instructions for use)

Technical specifications

  • Detection of drug resistance against isoniazid, ethionamide, fluoroquinolones, amikacin, kanamycin, capreomycin
  • Results within 90 minutes
  • Sample type: Sputum sediment, unprocessed sputum or culture liquid from Mycobacteria Growth Indicator Tube (MGIT)
  • Build-in quality controls:
    • Control process: Sample Processing Control (SPC) and Sample Volume Adequacy (SV)
    • Control: Probe Check Control (PCC)

Packaging & Labelling

10 tests/cartridges (= 1 kit)

Transport Dangerous Goods

  • UN2920
  • Hazard Class: 8 (3)
  • Packing group: II
  • Proper Shipping Name: Corrosive liquid, flammable, n.o.s. (sodium hydroxide, isopropanol)

Supplied with the Article

  • Sample reagent
  • Pipette
  • Self contained cartridge

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 between 2 and 28°C.
  • Do not use reagent or cartridges that have passed the expiration date
  • Shelf life : 17 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life
  • Not to be use beyond expiry date

Waste management

Contains substances with hazardous characteristics. Please contact your watsan referent for advice on proper disposal.

Detailed hazard and precautionary information can be found in the safety data sheet (SDS).

To be noted is the relative large volume of additional waste generated by Xpert MTB/XDR compared to smear microscopy.

Using the Sample Reagent reduced by 6 log organ viability of a sample.

Classification EC Regulation N° 1272/2008

  • Flammable Liquids 3 - H226
  • Skin Corrosion 1B - H314
Image Image

Signal Word

Danger

H226Flammable liquid and vapour.
H314Causes severe skin burns and eye damage.
P210Keep away from heat/sparks/open flames/hot surfaces. – No smoking.
P233Keep container tightly closed.
P260Do not breathe dust/fume/gas/mist/vapours/spray.
P264Wash … thoroughly after handling
P280Wear protective gloves/protective clothing/eye protection/face protection
P310Immediately call a POISON CENTER or doctor/physician.
P321Specific treatment (see ... on this label)
P363Wash contaminated clothing before reuse.
P301 + P330 + P331IF SWALLOWED: rinse mouth. Do NOT induce vomiting
P303 + P361 + P353IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing.
P304 + P340IF INHALED: Remove to fresh air and keep at rest in a position comfortable for breathing.
P305 + P351 + P338IF IN EYES: rinse cautiously with water for several minutes. If the victim wears contact lenses, remove them if possible. Keep rinsing
P370 + P378In case of fire: Use... for extinction.
P501Dispose of contents/container to location in accordance with local and regional/ national/ international regulations

MSF requirements

Reserved for TB programmes with adapted infrastructure.

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