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

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.

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

• 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.

• Sample Reagent
• Pipette
• Self contained cartridge

• See: Updated laboratory procedures, MSF, 2022
• See: WHO Model List of Essential In Vitro Diagnostics 2019
• See: GeneXpert MTB-RIF ELAEMBIT101 SOP, MSF, 2022
• See: MSF diagnostic packages, MSF, 2023

• 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

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.

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

Danger