(mb GeneXpert) TEST MTB/RIF, cartridge, CGXMTB/RIF-50


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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.
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
The order of this product needs to be justified and is only acceptable under certain conditions.
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).
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/RIF cartridge

This test cartridge will be discontinued by the manufacturer in Decembre 2023 and replaced by the MTB/RIF Ultra cartridge (see related items).


This test (= 1 cartridge) is worded and codified by unit to make the order easier, but it is always packaged in kit of 50.


The Xpert MTB/RIF assay runs on the GeneXpert System.

It is a cartridge-based, semiquantitative diagnostic test that can detect Mycobacterium tuberculosis (MTB) complex and resistance to rifampicin (RIF).

The Xpert® MTB/RIF/GeneXpert system purifies, concentrates, amplifies (by real-time PCR) and identifies targeted nucleic acid sequences in the genome of M. tuberculosis complex bacteria, and provides results from unprocessed sputum samples in 90 minutes, with minimal biohazard and limited technical training required to operate.


Test MTB/RIF for Rapid Molecular Detection of Tuberculosis and Rifampin Resistance.

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Technical specifications

Material Provided

The Xpert MTB/RIF kit (GXMTB/RIF-50) contains sufficient reagents to test 50 specimens.

The kit contains the following:

  • 50 Xpert MTB/RIF cartridges with integrated reaction tubes
  • Bead 1 (freeze-dried) quantity: 2 per cartridge
    • Primers / Probes / KCl / MgCl2 / HEPES, pH 8.0
    • BSA (bovine serum albumin)
  • Bead 2 (freeze-dried) quantity: 2 per cartridge
    • Polymerase / KCl / MgCl2 / dNTPs / HEPES, pH 7.2
    • BSA (bovine serum albumin)
  • Bead 3 (freeze-dried) quantity: 1 per cartridge
    • Sample Processing Control (SPC) 2000 non-infectious sample
    • Preparation control spores
  • Reagent 1 (Tris Buffer, EDTA, and surfactants) 4 ml per cartridge
  • Reagent 2 (Tris Buffer, EDTA, and surfactants) 4 ml per cartridge
  • Sample Reagent (Sodium Hydroxide and Isopropanol) 50 x 8 ml bottles
  • Sterile disposable transfer pipettes (x60)
  • Material Safety Data Sheets (MSDS) for all reagents

Quality Control

Each test includes a Sample Processing Control (SPC) and probe check control (PCC).

Sample Processing Control (SPC) ensures the sample was correctly processed. The SPC contains non-infectious spores in the form of a dry spore cake that is included in each cartridge to verify adequate processing of MTB. The SPC verifies that lysis of MTB has occurred if the organisms are present and verifies that specimen processing is adequate. Additionally, this control detects specimen associated inhibition of the real-time PCR assay.

The SPC should be positive in a negative sample and can be negative or positive in a positive sample. The SPC passes if it meets the validated acceptance criteria. The test result will be “Invalid” if the SPC is not detected in a negative test.

Probe Check Control (PCC): before the start of the PCR reaction, the GeneXpert Dx System measures the fluorescence signal from the probes to monitor bead rehydration, reaction-tube filling, probe integrity and dye stability. Probe Check passes if it meets the assigned acceptance criteria.

Packaging & Labelling

1 kit = 50 tests (5 pouches of 10 cartridges)

Transport Dangerous Goods

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

Cepheid sends MTB kits in special box that can hold up to 6 kits (80 ml of hazardous materials per kit) so 480 ml per secondary packaging. This allows to send large quantities of the product because the total quantity does not exceed 500 ml per packaging, which is the limit for the UN dangerous products.

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.


For offline access, contact your laboratory advisor.

Precautions for Use

  • Do not open a cartridge until you are ready to perform testing.
  • Start the test within 4 hours of adding the sample reagent-treated sample to the cartridge (GeneXpert DX Instrument).
  • The cartridge is stable up to 6 weeks at 2-45°C after opening the pouch.


  • Store between 2- 28°C
  • Do not open a cartridge until ready to test.
  • Shelf Life: 21 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life
  • Not to be use beyond expiry date

Waste management

Substance 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/RIF compared to smear microscopy

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

Classification EC Regulation N° 1272/2008

  • Flammable liquid: Category 3, H226
  • Skin corrosion: Category 1B, H314
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Signal Word


H226Flammable liquid and vapour.
H314Causes severe skin burns and eye damage.
H341Suspected of causing genetic defects (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard).
H361Suspected of damaging fertility or the unborn child (route of exposure if it is conclusively proven that no other routes of exposure cause the hazard).
H373May cause damage to organs (or state all organs affected, if known) through prolonged or repeated exposure (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard).
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
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