REAL-TIME PCR SYSTEM (GeneXpert GXIV-4-D-10C)4mod-10col.+DT

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REAL-TIME PCR SYSTEM (GeneXpert GX-IV)

The first generation GeneXpert machines are using modules with 6 colour multiplexing technology. Cepheid more recently launched GeneXpert new modules with a 10-colour multiplexing technology to be used in GeneXpert Systems.

Definition

The Cepheid GeneXpert system is a simple-to-use, cartridge-based, closed system that integrates all processes necessary to perform nucleic acid amplification testing (NAAT).

Specifications

Replacement of the current 6-color modules by the new 10-color modules will be organized gradually in MSF projects and prioritized by each operational center.

  • MTB/RIF, MTB/RIF Ultra, HIV, HCV, SARS-CoV2 GeneXpert cartridges can be used with the 10-color as well as the current 6-color modules
  • The new MTB-XDR cartridge can only be used with the 10-color module.

Contact your laboratory advisor for more information.

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Quality standards

ISO 20395, 2019, edition 1, Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR

Technical specifications

  • Capabilities : 6 color detection or 6+4 color detection depending of the model.
  • Computer operating system XP, 7, 10 (6-color system) or 7, 10 (10-color system)
  • GeneXpert Dx software : 4.4a to 6.4 (6-color) or 6.2 to higher (10-color)
  • Power supply:
    • Rated AC voltage range: 100–240 V~, 50–60Hz
    • Mains supply fluctuations: up to ± 10% of the nominal voltage
    • Transient over-voltages: up to 2500 V peak (impulse withstand category II)
    • Rated Current: 1.9A @ 100V, 0.95A @ 200V~
    • Fuse Rating: 250 V~ T3A (IEC 60127 time-delay type)
  • Operational environmental parameters :
    • General environment: Indoor only
    • Operating temperature: 15–30°C
    • Operating temperature required for maximum thermal ramp rates: 20–25°C
    • Relative humidity: 10%–95%, non-condensing

Place the GeneXpert Dx instrument away from heat and air conditioning ducts. Do not place the instrument directly under an air vent or in direct sunlight. Keep free space around the machine. Always keep the instrument module doors closed when not in use.

The operating temperature for GeneXpert IV® device is 15-30°C, air-conditioning is necessary in locations where the temperatures exceeds these.

Dimensions

  • Width 29.8 cm (11.75 in)
  • Height 35.6 cm (14 in)
  • Depth 31.1 cm (12.25 in)
  • Weight: 12 kg (26 lb)

Supplied with the Article

  • Barcode reader
  • Desktop computer (with screen, keyboard, mouse) or laptop
  • Sofware: Genexpert DX (installed), Antivirus, Windows
  • Connector cable for the GX4

Instructions for use

Follow the instructions manual

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.

Precautions for Use

Emergency power supplies must be ordered with the device. Depending on the context:

For cuts of a few seconds to a few minutes or longer cuts of several hours the use of an adapted UPS is recommended. Please contact your biomedical advisor for advice.

Maintenance

A major maintenance intervention foreseen for the GeneXpert platform is the regular control of the proper calibration of modules. Modules need to be checked after 1 year from the date of invoice or after 2000 tests (whichever is reached first) with the Xpert Check cartridges provided for this purpose.

The first calibration check must be carried out after the first year of use at the end of the warranty period. If this is respected, an additional year of warranty is offered by manufacturer Cepheid to MSF.

In the following two years, a "Xpert total support" contract can be subscribed of choice, otherwise calibration checks and maintenance of modules will be managed on a case by case basis between MSF and Cepheid. Contact your laboratory or biomedical referent for the best solution according to your context.

The warranty starts from the date of the invoice from Cepheid to the supply centre. As this date is not systematically communicated, do not hesitate to ask for it when placing the order.

The period of warranty is 1 year from the date of the invoice, extended to 2 years if Xpert Check checks are carried out in the first year. This warranty includes the same services as the ones listed in the contract Xpert total support, apart from calibration.

In case of failure on one module (GX4), the module will have to be sent back to Cepheid France through your MSF procurement center. Cepheid will provide a loan or equivalent equipment during the time of intervention, if the equipment is covered either by warranty or service contract.

Storage

Environmental Conditions for Storage and Transport:

  • Temperature: -30°C to +45°C
  • Humidity: 0%–95% relative humidity, non-condensing
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